CONSORT: Safety and Efficacy of Pre-defined, Fixed Dose of Gonal-f Pen Based on Subject Baseline Characteristics in Subjects Undergoing in Vitro Fertilization (IVF)

• Sponsor: Merck KGaA, Darmstadt, Germany (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00249834
• Collaborator: (none)
• Enrollment: 166
• Location: 1
• Arms: 8
• Actual Duration (Months): 15.8
• Patients Per Site Per Month: 10.5

Study Details

Study Description

Brief Summary

Clinical validation of the assisted reproductive technology (ART) treatment guidelines, which determine the optimal dose of recombinant human follicle stimulating hormone (r-hFSH) based on subject baseline characteristics/predictors of ovarian response.

Condition or Disease	Intervention/Treatment	Phase
Infertility	Drug: Gonal-f; Drug: Recombinant human chorionic gonadotrophin (r-hCG)	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 166 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase IIIB/IV, Open Label Study to Assess the Efficacy and Safety of a Pre-defined, Fixed Dose of Gonal-f® (Filled-by-Mass in a Prefilled Pen) Based on Subject Baseline Characteristics, for Ovarian Stimulation in Subjects Undergoing in Vitro Fertilization (IVF)
• Actual Study Start Date: Sep 22, 2004
• Actual Primary Completion Date: Jan 16, 2006
• Actual Study Completion Date: Jan 16, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Gonal-f 112.5 IU	Drug: Gonal-f; GONAL-f (follitropin alfa) will be administered subcutaneously based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle.; Other Names: follitropin alfa Recombinant Human Follicle Stimulating Hormone (r-hFSH) ; Drug: Recombinant human chorionic gonadotrophin (r-hCG); When at least 1 follicle greater than or equal to (>=) 18 millimeter (mm) and 2 follicles >=16 mm in diameter develop, 250 microgram (mcg) of recombinant human chorionic gonadotrophin (r-hCG) will be administered.
Experimental: Gonal-f 37.5 IU	Drug: Gonal-f; GONAL-f (follitropin alfa) will be administered subcutaneously based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle.; Other Names: follitropin alfa Recombinant Human Follicle Stimulating Hormone (r-hFSH) ; Drug: Recombinant human chorionic gonadotrophin (r-hCG); When at least 1 follicle greater than or equal to (>=) 18 millimeter (mm) and 2 follicles >=16 mm in diameter develop, 250 microgram (mcg) of recombinant human chorionic gonadotrophin (r-hCG) will be administered.
Experimental: Gonal-f 75 IU	Drug: Gonal-f; GONAL-f (follitropin alfa) will be administered subcutaneously based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle.; Other Names: follitropin alfa Recombinant Human Follicle Stimulating Hormone (r-hFSH) ; Drug: Recombinant human chorionic gonadotrophin (r-hCG); When at least 1 follicle greater than or equal to (>=) 18 millimeter (mm) and 2 follicles >=16 mm in diameter develop, 250 microgram (mcg) of recombinant human chorionic gonadotrophin (r-hCG) will be administered.
Experimental: Gonal-f 150 IU	Drug: Gonal-f; GONAL-f (follitropin alfa) will be administered subcutaneously based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle.; Other Names: follitropin alfa Recombinant Human Follicle Stimulating Hormone (r-hFSH) ; Drug: Recombinant human chorionic gonadotrophin (r-hCG); When at least 1 follicle greater than or equal to (>=) 18 millimeter (mm) and 2 follicles >=16 mm in diameter develop, 250 microgram (mcg) of recombinant human chorionic gonadotrophin (r-hCG) will be administered.
Experimental: Gonal-f 187.5 IU	Drug: Gonal-f; GONAL-f (follitropin alfa) will be administered subcutaneously based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle.; Other Names: follitropin alfa Recombinant Human Follicle Stimulating Hormone (r-hFSH) ; Drug: Recombinant human chorionic gonadotrophin (r-hCG); When at least 1 follicle greater than or equal to (>=) 18 millimeter (mm) and 2 follicles >=16 mm in diameter develop, 250 microgram (mcg) of recombinant human chorionic gonadotrophin (r-hCG) will be administered.
Experimental: Gonal-f 225 IU	Drug: Gonal-f; GONAL-f (follitropin alfa) will be administered subcutaneously based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle.; Other Names: follitropin alfa Recombinant Human Follicle Stimulating Hormone (r-hFSH) ; Drug: Recombinant human chorionic gonadotrophin (r-hCG); When at least 1 follicle greater than or equal to (>=) 18 millimeter (mm) and 2 follicles >=16 mm in diameter develop, 250 microgram (mcg) of recombinant human chorionic gonadotrophin (r-hCG) will be administered.
Experimental: Gonal-f 262.5 IU	Drug: Gonal-f; GONAL-f (follitropin alfa) will be administered subcutaneously based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle.; Other Names: follitropin alfa Recombinant Human Follicle Stimulating Hormone (r-hFSH) ; Drug: Recombinant human chorionic gonadotrophin (r-hCG); When at least 1 follicle greater than or equal to (>=) 18 millimeter (mm) and 2 follicles >=16 mm in diameter develop, 250 microgram (mcg) of recombinant human chorionic gonadotrophin (r-hCG) will be administered.
Experimental: Gonal-f 300 IU	Drug: Gonal-f; GONAL-f (follitropin alfa) will be administered subcutaneously based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle.; Other Names: follitropin alfa Recombinant Human Follicle Stimulating Hormone (r-hFSH) ; Drug: Recombinant human chorionic gonadotrophin (r-hCG); When at least 1 follicle greater than or equal to (>=) 18 millimeter (mm) and 2 follicles >=16 mm in diameter develop, 250 microgram (mcg) of recombinant human chorionic gonadotrophin (r-hCG) will be administered.

Outcome Measures

Primary Outcome Measures

1. Number of Oocytes Retrieved [Ovum pick up day (34 to 38 hours post r-hCG administration)]

   Mean number of oocytes retrieved on the day of ovum pick up (OPU) was calculated. Oocyte retrieval was a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body. As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.

Secondary Outcome Measures

1. Total Dose of Recombinant Human Follicle Stimulating Hormone (r-hFSH) [up to end of stimulation cycle (approximately 31 days)]

   As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.

2. Mean Number of Ovarian Stimulation Days [up to end of stimulation cycle (approximately 31 days)]

   The mean number of stimulation days were determined based on the treatment administration information collected in the case report form. Ovarian stimulation included time from first r-hFSH injection (stimulation Day) until day on which r-hCG was administered (r-hCG day). As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.

3. Percentage of Cycles Cancelled Due to Excessive or Inadequate Response to r-hFSH [up to end of stimulation cycle (approximately 31 days)]

   As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.

4. Number of Subjects Needing Dose Adjustment [6 days post r-hFSH treatment]

   Number of subjects needing increase in dose, decrease in dose or increase and decrease both in dose were reported. As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.

5. Mean Daily Recombinant Human Follicle Stimulating Hormone (r-hFSH) Dose [up to end of stimulation cycle (approximately 31 days)]

   As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.

6. Embryo Implantation Rate [35-42 days post r-hCG administration]

   Embryo implantation rate was measured as the number of gestational sacs observed divided by the number of embryos transferred multiplied by 100. As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.

7. Overall Pregnancy Rate, Clinical Rate and Multiple Pregnancy Rate [35-42 days post r-hCG administration]

   Overall pregnancy rate was defined as the percentage of subjects with serum beta-hCG levels greater than 10 IU/L. Clinical pregnancy rate was defined as the percentage of subjects with at least 1 ultrasound confirmed gestational sac, with or without foetal heart activity. Multiple pregnancy rate was defined as the percentage of subjects with more than 1 ultrasound confirmed gestational sac in the uterus with fetal heart activity. As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 34 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria

• Be an infertile subject justifying an in-vitro fertilization/embryo transfer (IVF/ET) treatment.

• Have a male partner with semen analysis within the past six months prior to study entry considered adequate to proceed with regular insemination or intracytoplasmic sperm injection (ICSI) according to the center's standard practice. If these criteria are not met, the subject can only be entered if donor sperm will be used.

• Be between her 18th and 35th birthday (35 not included).

• Have a regular spontaneous ovulatory menstrual cycle between 21 and 35 days in length.

• Have early follicular phase (Day 2-4) serum levels within the last 3 months prior to study entry of:

• Follicle stimulating hormone (FSH) greater than or equal to (>=) 12 International units per liter (IU/L), and

• Oestradiol (E2) within center's local normal laboratory range values.

• Presence of both ovaries.

• Have a uterine cavity without abnormalities, which, in the investigator's opinion, could impair embryo implantation or pregnancy evolution as assessed within the last 3 years using ultrasound (US), hysteroscopy (HSC), or hysterosalpingography (HSG).

• Have a negative cervical papanicolaou (PAP) test within the last 6 months prior to study entry.

• Have at least one wash-out cycle (defined as >= 30 days since the last dose of clomiphene citrate or gonadotrophin treatment) since the last ART cycle and/or clomiphene citrate or gonadotrophin treatment prior to starting gonadotrophin releasing hormone (GnRH) agonist therapy.

• Have a negative pregnancy test prior to beginning GnRH agonist therapy.

• Be willing and able to comply with the protocol for the duration of the study. Have given written informed consent, prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to her future medical care.

Exclusion Criteria:

• Had 2 previous ART cycles with a poor response to gonadotrophin stimulation, defined as less than or equal to (<=) 5 mature follicles and/or <=3 oocytes collected in any previous IVF cycle or hyper response, defined as >=25 oocytes retrieved.

• Any medical condition, which in the judgement of the investigator may interfere with the absorption, distribution, metabolism or excretion of the drug. In case of doubt, the subject in question should be discussed with Serono's Therapeutic Director.

• Had previous severe ovarian hyperstimulation syndrome (OHSS).

• A body mass index (BMI) greater than (>) 30 kilogram per square meter (kg/m^2)

• Any contraindication to being pregnant and/or carrying a pregnancy to term.

• Extra-uterine pregnancy within the last 3 months.

• History of 3 or more miscarriages (early or late miscarriages) due to any cause.

• Tumours of the hypothalamus and pituitary gland.

• Ovarian enlargement or cyst of unknown aetiology.

• Ovarian, uterine or mammary cancer.

• A clinically significant systemic disease.

• Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or C virus.

• Abnormal gynaecological bleeding of undetermined origin.

• Known allergy or hypersensitivity to human gonadotrophin preparations.

• Any active substance abuse or history of drug, medication or alcohol abuse in the past 5 years.

• Entered previously into this study or simultaneous participation in another clinical trial

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical Information	Paris		France

Sponsors and Collaborators

• Merck KGaA, Darmstadt, Germany

Investigators

• Study Director: Medical Responsible, Merck KGaA, Darmstadt, Germany

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Full FDA approved prescribing information can be found here

Publications

• Olivennes F, Howles CM, Borini A, Germond M, Trew G, Wikland M, Zegers-Hochschild F, Saunders H, Alam V; CONSORT study group. Individualizing FSH dose for assisted reproduction using a novel algorithm: the CONSORT study. Reprod Biomed Online. 2009 Feb;18(2):195-204.

• Responsible Party: Merck KGaA, Darmstadt, Germany
• ClinicalTrials.gov Identifier: NCT00249834
• Other Study ID Numbers: 25198
• First Posted: Nov 7, 2005
• Last Update Posted: Mar 30, 2018
• Last Verified: Aug 1, 2017

• Keywords provided by Merck KGaA, Darmstadt, Germany: Assisted Reproductive Technology (ART); Infertility; Ovarian stimulation
• Additional relevant MeSH terms: Infertility; Chorionic Gonadotropin; Follicle Stimulating Hormone

Study Results

Participant Flow

Pre-assignment Detail	A total of 166 subjects received at least 1 dose of recombinant human follicle stimulating hormone (r-hFSH). Of these, 161 subjects received r-hFSH in a dose group of 5 or more subjects. As per statistical analysis plan, only dose groups having 5 or more subjects were to be analyzed for efficacy and safety analysis in this study.

Arm/Group Title	Gonal-f 37.5 IU	Gonal-f 75 IU	Gonal-f 112.5 IU	Gonal-f 150 IU	Gonal-f 187.5 IU	Gonal-f 225 IU	Gonal-f 262.5 IU	Gonal-f 300 IU
Arm/Group Description	GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 37.5 International Units (IU) per day based on assisted reproductive technology (ART) treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle greater than or equal to (>=) 18 millimeter (mm) and 2 follicles >=16 mm in diameter were developed, a single injection of 250 microgram (mcg) of recombinant human chorionic gonadotrophin (r-hCG) was administered.	GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 75 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.	GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 112.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.	GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 150 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.	GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 187.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.	GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 225 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.	GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 262.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.	GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 300 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
Period Title: Overall Study
STARTED	1	48	45	34	24	10	2	2
COMPLETED	0	29	31	26	19	8	1	2
NOT COMPLETED	1	19	14	8	5	2	1	0

Baseline Characteristics

Arm/Group Title	Gonal-f 37.5 IU	Gonal-f 75 IU	Gonal-f 112.5 IU	Gonal-f 150 IU	Gonal-f 187.5 IU	Gonal-f 225 IU	Gonal-f 262.5 IU	Gonal-f 300 IU	Total
Arm/Group Description	GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 37.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.	GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 75 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.	GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 112.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.	GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 150 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.	GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 187.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.	GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 225 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.	GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 262.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.	GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 300 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.	Total of all reporting groups
Overall Participants	1	48	45	34	24	10	2	2	166
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	1 100%	48 100%	45 100%	34 100%	24 100%	10 100%	2 100%	2 100%	166 100%
>=65 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	1 100%	48 100%	45 100%	34 100%	24 100%	10 100%	2 100%	2 100%	166 100%
Male	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Number of Oocytes Retrieved
Description	Mean number of oocytes retrieved on the day of ovum pick up (OPU) was calculated. Oocyte retrieval was a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body. As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.
Time Frame	Ovum pick up day (34 to 38 hours post r-hCG administration)

Outcome Measure Data

Analysis Population Description

Intention-To-Treat (ITT) population included all 161 treated subjects who received at least 1 injection of r-hFSH, and were allocated to a dosage group that contained at least 5 subjects. Here "overall number of subjects analyzed" signifies those subjects who were evaluable for this outcome measure.

Arm/Group Title	Gonal-f 75 IU	Gonal-f 112.5 IU	Gonal-f 150 IU	Gonal-f 187.5 IU	Gonal-f 225 IU
Arm/Group Description	GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 75 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.	GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 112.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.	GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 150 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.	GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 187.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.	GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 225 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
Measure Participants	34	39	31	22	9
Mean (Standard Deviation) [Oocytes]	8.3 (4.5)	9.6 (6.5)	12.1 (6.4)	12.7 (4.3)	8.3 (3.8)

2. Secondary Outcome

Title	Total Dose of Recombinant Human Follicle Stimulating Hormone (r-hFSH)
Description	As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.
Time Frame	up to end of stimulation cycle (approximately 31 days)

Outcome Measure Data

Analysis Population Description

ITT population included all 161 treated subjects who received at least 1 injection of r-hFSH, and were allocated to a dosage group that contained at least 5 subjects.

Arm/Group Title	Gonal-f 75 IU	Gonal-f 112.5 IU	Gonal-f 150 IU	Gonal-f 187.5 IU	Gonal-f 225 IU
Arm/Group Description	GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 75 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.	GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 112.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.	GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 150 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.	GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 187.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.	GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 225 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
Measure Participants	48	45	34	24	10
Mean (Standard Deviation) [International Units (IU)]	1102.3 (671.8)	1287.2 (447.0)	1632.4 (341.5)	2043.8 (276.2)	2572.5 (552.3)

3. Secondary Outcome

Title	Mean Number of Ovarian Stimulation Days
Description	The mean number of stimulation days were determined based on the treatment administration information collected in the case report form. Ovarian stimulation included time from first r-hFSH injection (stimulation Day) until day on which r-hCG was administered (r-hCG day). As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.
Time Frame	up to end of stimulation cycle (approximately 31 days)

Outcome Measure Data

Analysis Population Description

ITT population included all 161 treated subjects who received at least 1 injection of r-hFSH, and were allocated to a dosage group that contained at least 5 subjects.

Arm/Group Title	Gonal-f 75 IU	Gonal-f 112.5 IU	Gonal-f 150 IU	Gonal-f 187.5 IU	Gonal-f 225 IU
Arm/Group Description	GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 75 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.	GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 112.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.	GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 150 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.	GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 187.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.	GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 225 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
Measure Participants	48	45	34	24	10
Mean (Standard Deviation) [Days]	12.5 (4.4)	11.0 (2.9)	10.6 (1.8)	11.0 (1.4)	11.5 (2.4)

4. Secondary Outcome

Title	Percentage of Cycles Cancelled Due to Excessive or Inadequate Response to r-hFSH
Description	As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.
Time Frame	up to end of stimulation cycle (approximately 31 days)

Outcome Measure Data

Analysis Population Description

ITT population included all 161 treated subjects who received at least 1 injection of r-hFSH, and were allocated to a dosage group that contained at least 5 subjects.

Arm/Group Title	Gonal-f 75 IU	Gonal-f 112.5 IU	Gonal-f 150 IU	Gonal-f 187.5 IU	Gonal-f 225 IU
Arm/Group Description	GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 75 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.	GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 112.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.	GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 150 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.	GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 187.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.	GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 225 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
Measure Participants	48	45	34	24	10
Excessive response	0.0	0.0	2.9	0.0	0.0
Inadequate response	25.0	8.9	8.8	8.3	20.0

5. Secondary Outcome

Title	Number of Subjects Needing Dose Adjustment
Description	Number of subjects needing increase in dose, decrease in dose or increase and decrease both in dose were reported. As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.
Time Frame	6 days post r-hFSH treatment

Outcome Measure Data

Analysis Population Description

ITT population included all 161 treated subjects who received at least 1 injection of r-hFSH, and were allocated to a dosage group that contained at least 5 subjects.

Arm/Group Title	Gonal-f 75 IU	Gonal-f 112.5 IU	Gonal-f 150 IU	Gonal-f 187.5 IU	Gonal-f 225 IU
Arm/Group Description	GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 75 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.	GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 112.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.	GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 150 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.	GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 187.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.	GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 225 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
Measure Participants	48	45	34	24	10
Increase	7	3	3	1	0
Decrease	0	0	1	2	1
Increase and decrease both	2	3	0	0	0

6. Secondary Outcome

Title	Mean Daily Recombinant Human Follicle Stimulating Hormone (r-hFSH) Dose
Description	As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.
Time Frame	up to end of stimulation cycle (approximately 31 days)

Outcome Measure Data

Analysis Population Description

ITT population included all 161 treated subjects who received at least 1 injection of r-hFSH, and were allocated to a dosage group that contained at least 5 subjects.

Arm/Group Title	Gonal-f 75 IU	Gonal-f 112.5 IU	Gonal-f 150 IU	Gonal-f 187.5 IU	Gonal-f 225 IU
Arm/Group Description	GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 75 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.	GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 112.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.	GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 150 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.	GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 187.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.	GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 225 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
Measure Participants	48	45	34	24	10
Mean (Standard Deviation) [IU/day]	84.4 (21.6)	114.7 (16.4)	153.6 (12.8)	186.5 (5.8)	223.3 (5.3)

7. Secondary Outcome

Title	Embryo Implantation Rate
Description	Embryo implantation rate was measured as the number of gestational sacs observed divided by the number of embryos transferred multiplied by 100. As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.
Time Frame	35-42 days post r-hCG administration

Outcome Measure Data

Analysis Population Description

ITT population included all 161 treated subjects who received at least 1 injection of r-hFSH, and were allocated to a dosage group that contained at least 5 subjects. Here "overall number of subjects analyzed" signifies those subjects who were evaluable for this outcome measure.

Arm/Group Title	Gonal-f 75 IU	Gonal-f 112.5 IU	Gonal-f 150 IU	Gonal-f 187.5 IU	Gonal-f 225 IU
Arm/Group Description	GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 75 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.	GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 112.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.	GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 150 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.	GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 187.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.	GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 225 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
Measure Participants	32	37	29	22	7
Mean (Standard Deviation) [Percent sacs per embryo]	36.5 (42.8)	24.3 (35.0)	28.2 (38.9)	37.1 (40.5)	11.9 (20.9)

8. Secondary Outcome

Title	Overall Pregnancy Rate, Clinical Rate and Multiple Pregnancy Rate
Description	Overall pregnancy rate was defined as the percentage of subjects with serum beta-hCG levels greater than 10 IU/L. Clinical pregnancy rate was defined as the percentage of subjects with at least 1 ultrasound confirmed gestational sac, with or without foetal heart activity. Multiple pregnancy rate was defined as the percentage of subjects with more than 1 ultrasound confirmed gestational sac in the uterus with fetal heart activity. As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.
Time Frame	35-42 days post r-hCG administration

Outcome Measure Data

Analysis Population Description

ITT population included all 161 treated subjects who received at least 1 injection of r-hFSH, and were allocated to a dosage group that contained at least 5 subjects.

Arm/Group Title	Gonal-f 75 IU	Gonal-f 112.5 IU	Gonal-f 150 IU	Gonal-f 187.5 IU	Gonal-f 225 IU
Arm/Group Description	GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 75 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.	GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 112.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.	GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 150 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.	GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 187.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.	GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 225 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
Measure Participants	48	45	34	24	10
Total pregnancy	17	18	16	16	2
Clinical pregnancy	15	14	12	12	2
Multiple pregnancy	3	2	4	3	0

Adverse Events

Adverse Event Reporting Description	As per statistical analysis plan, safety analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.
Arm/Group Title	Gonal-f 75 IU		Gonal-f 112.5 IU		Gonal-f 150 IU		Gonal-f 187.5 IU		Gonal-f 225 IU
Arm/Group Description	GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 75 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.		GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 112.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.		GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 150 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.		GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 187.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.		GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 225 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered.
All Cause Mortality
	Gonal-f 75 IU		Gonal-f 112.5 IU		Gonal-f 150 IU		Gonal-f 187.5 IU		Gonal-f 225 IU
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Gonal-f 75 IU		Gonal-f 112.5 IU		Gonal-f 150 IU		Gonal-f 187.5 IU		Gonal-f 225 IU
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/48 (6.3%)		3/45 (6.7%)		1/34 (2.9%)		1/24 (4.2%)		0/10 (0%)
Infections and infestations
Urinary tract infection	0/48 (0%)		1/45 (2.2%)		0/34 (0%)		0/24 (0%)		0/10 (0%)
Pregnancy, puerperium and perinatal conditions
Abortion	1/48 (2.1%)		0/45 (0%)		0/34 (0%)		0/24 (0%)		0/10 (0%)
Ectopic pregnancy	0/48 (0%)		1/45 (2.2%)		0/34 (0%)		0/24 (0%)		0/10 (0%)
Imminent abortion	1/48 (2.1%)		0/45 (0%)		0/34 (0%)		0/24 (0%)		0/10 (0%)
Reproductive system and breast disorders
Ovarian hyperstimulation syndrome	2/48 (4.2%)		0/45 (0%)		0/34 (0%)		1/24 (4.2%)		0/10 (0%)
Ovarian torsion	0/48 (0%)		0/45 (0%)		1/34 (2.9%)		0/24 (0%)		0/10 (0%)
Pelvic pain	0/48 (0%)		1/45 (2.2%)		0/34 (0%)		0/24 (0%)		0/10 (0%)
Vascular disorders
Jugular vein thrombosis	1/48 (2.1%)		0/45 (0%)		0/34 (0%)		0/24 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Gonal-f 75 IU		Gonal-f 112.5 IU		Gonal-f 150 IU		Gonal-f 187.5 IU		Gonal-f 225 IU
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/48 (22.9%)		15/45 (33.3%)		5/34 (14.7%)		10/24 (41.7%)		3/10 (30%)
Gastrointestinal disorders
Abdominal pain upper	0/48 (0%)		0/45 (0%)		2/34 (5.9%)		0/24 (0%)		0/10 (0%)
Diarrhoea	0/48 (0%)		1/45 (2.2%)		0/34 (0%)		0/24 (0%)		0/10 (0%)
Nausea	1/48 (2.1%)		0/45 (0%)		0/34 (0%)		0/24 (0%)		0/10 (0%)
Abdominal pain	0/48 (0%)		0/45 (0%)		0/34 (0%)		0/24 (0%)		1/10 (10%)
General disorders
Injection site pain	0/48 (0%)		2/45 (4.4%)		0/34 (0%)		0/24 (0%)		0/10 (0%)
Fatigue	0/48 (0%)		1/45 (2.2%)		0/34 (0%)		0/24 (0%)		0/10 (0%)
Oedema peripheral	0/48 (0%)		1/45 (2.2%)		0/34 (0%)		0/24 (0%)		0/10 (0%)
Infections and infestations
Influenza	1/48 (2.1%)		0/45 (0%)		0/34 (0%)		0/24 (0%)		1/10 (10%)
Gastroenteritis	0/48 (0%)		1/45 (2.2%)		0/34 (0%)		0/24 (0%)		0/10 (0%)
Tonsillitis	1/48 (2.1%)		0/45 (0%)		0/34 (0%)		0/24 (0%)		0/10 (0%)
Vulvitis	0/48 (0%)		1/45 (2.2%)		0/34 (0%)		0/24 (0%)		0/10 (0%)
Pneumonia	0/48 (0%)		0/45 (0%)		0/34 (0%)		0/24 (0%)		1/10 (10%)
Injury, poisoning and procedural complications
Post procedural pain	1/48 (2.1%)		1/45 (2.2%)		0/34 (0%)		0/24 (0%)		0/10 (0%)
Nervous system disorders
Headache	2/48 (4.2%)		7/45 (15.6%)		0/34 (0%)		5/24 (20.8%)		1/10 (10%)
Dizziness	0/48 (0%)		1/45 (2.2%)		0/34 (0%)		0/24 (0%)		0/10 (0%)
Myasthenic syndrome	0/48 (0%)		0/45 (0%)		0/34 (0%)		0/24 (0%)		1/10 (10%)
Psychiatric disorders
Anxiety	0/48 (0%)		0/45 (0%)		0/34 (0%)		1/24 (4.2%)		0/10 (0%)
Reproductive system and breast disorders
Vaginal haemorrhage	3/48 (6.3%)		0/45 (0%)		0/34 (0%)		0/24 (0%)		0/10 (0%)
Adnexa uteri pain	1/48 (2.1%)		1/45 (2.2%)		0/34 (0%)		0/24 (0%)		0/10 (0%)
Metrorrhagia	0/48 (0%)		1/45 (2.2%)		0/34 (0%)		0/24 (0%)		0/10 (0%)
Ovarian cyst	0/48 (0%)		0/45 (0%)		1/34 (2.9%)		0/24 (0%)		0/10 (0%)
Vulvovaginal discomfort	1/48 (2.1%)		0/45 (0%)		0/34 (0%)		0/24 (0%)		0/10 (0%)
Breast pain	0/48 (0%)		0/45 (0%)		0/34 (0%)		0/24 (0%)		1/10 (10%)
Ovarian hyperstimulation syndrome	1/48 (2.1%)		2/45 (4.4%)		1/34 (2.9%)		3/24 (12.5%)		1/10 (10%)
Pelvic pain	0/48 (0%)		1/45 (2.2%)		0/34 (0%)		1/24 (4.2%)		1/10 (10%)
Ovarian torsion	0/48 (0%)		0/45 (0%)		0/34 (0%)		0/24 (0%)		0/10 (0%)
Surgical and medical procedures
Uterine operation	0/48 (0%)		0/45 (0%)		1/34 (2.9%)		0/24 (0%)		0/10 (0%)
Vascular disorders
Flushing	0/48 (0%)		1/45 (2.2%)		0/34 (0%)		0/24 (0%)		0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.