Study to Compare Efficacy and Safety of Primapur and Gonal-f in Women for Assisted Reproductive Treatment

• Sponsor: IVFarma LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03088137
• Collaborator: BridgePharm LLC (Other), GlobalPharma LLC (Other)
• Enrollment: 118
• Locations: 3
• Arms: 2
• Actual Duration (Months): 18.2
• Patients Per Site: 39.3
• Patients Per Site Per Month: 2.2

Study Details

Study Description

Brief Summary

The purpose of this study is to show equivalence with regard to the number of oocytes retrieved between follitropin alfa (pen-injectors) Primapur® and Gonal-f® in woman undergoing IVF/ICSI

Condition or Disease	Intervention/Treatment	Phase
Infertility, Female	Drug: Follitropin alfa (Gonal-f); Drug: Follitropin alfa (Primapur)	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 118 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Multicentre Study to Compare Efficacy and Safety of Primapur and Gonal-f in Women for Assisted Reproductive Treatment
• Actual Study Start Date: Feb 8, 2017
• Actual Primary Completion Date: Aug 17, 2018
• Actual Study Completion Date: Aug 17, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Primapur (Follitropin alfa)	Drug: Follitropin alfa (Primapur); Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
Active Comparator: Gonal-f (Follitropin alfa)	Drug: Follitropin alfa (Gonal-f); Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation

Outcome Measures

Primary Outcome Measures

1. Oocytes (Intention-to-Treat, ITT) [From date of randomization up to 18 days]

   The total number of retrieved oocytes at the day of ovum pick-up. No more than 37 hours from the introduction of the trigger of ovulation (hCG or GnRH-agonist). The equivalence in the number of retrieved oocytes was tested using a predetermined equivalence margin of +/- 3.4 oocytes.

Secondary Outcome Measures

1. Number of Follicles With Size ≥ 16 mm [From date of randomization up to 16 days]

   The number of follicles 16 mm or over in diameter at the day of hCG (or GnRH-agonist) administration

2. Mature Oocytes [From date of randomization up to 18 days]

   The number of mature oocytes (MII stage of development)

3. Fertilised Oocytes [From date of randomization up to 19 days]

   The number of fertilised oocytes with the presence of two pronuclei: 2PN

4. Percentage of Patients With Embryo Transfer [From date of randomization up to 25 days]

   The number of patients (and percentage) with embryo transfers on days 3 and 5 after ovum pick-up

5. Total Dose of Follitropin Alfa [From date of randomization up to 16 days]

   The total dose of the follitropin alfa administrated during the ovarian hyperstimulation protocol (measured in International Units - IU)

6. Number of Days of Follitropin Alfa Treatment [From date of randomization up to 16 days]

   The duration of ovarian hyperstimulation protocol (at the day of trigger of ovulation)

7. Number of Patients With Follitropin Alfa Dose Correction [From date of randomization up to 16 days]

   The number of dose adjustments during the ovarian hyperstimulation protocol (increment 25-50 IU)

8. Number of Patients With Cycle Cancellation [From date of randomization up to 16 days]

   The number of the ovarian hyperstimulation protocol cancellation (at the day of trigger of ovulation)

9. Number of No-responders [From date of randomization up to 8 days]

   The number of patients with no response to follitropin alfa treatment (absence of growing follicles, no any oocytes obtained at the day of ovum pick-up)

10. Percentage of Patients With Serum hCG More Than 25 IU/l [From date of randomization up to 42 days]

    Biochemical pregnancy test: serum hCG more than 25 IU/l (days 12-17 after embryo transfer)

11. Percentage of Patients With the Evidence for Clinical Pregnancy [The 10th week after embryo transfer]

    Confirmation of clinical pregnancy: ultrasound detection of intrauterine gestational sac and heart activity

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 35 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Infertility due to tubal factor and/or male factor

• Age between 20 and 35 years with regular menstrual cycles of 21-35 days

• First or second cycle in the present series of ART

• BMI (body mass index) ≥ 18 ≤ 30 kg/m2

• Basal FSH (follicle stimulating hormone) < 10 IU/L (cycle day 2-5)

• E2 (estradiol) levels < 50pg/mL (cycle day 2)

• AMH (anti-mullerian hormone) ≥ 1.0 ng/ml

• Antral follicle ≥ 4 to ≤ 15 follicles (both ovaries)

• Presence of both ovaries and normal uterine cavity

• Informed consent

Exclusion Criteria:

• Presence of pregnancy

• Hypersensitivity to follitropin alfa

• Ovarian cysts

• History of ≥2 succeeding ART (assisted reproductive technology) cycles IVF (in vitro fertilization) and/or ICSI (Intracytoplasmic sperm injection) before the study cycle

• Previous history of severe ovarian hyperstimulation syndrome

• Presence of polycystic ovaries (PCO)

• Presence of endometriosis and hydrosalpinx

• Presence of uterine disorders

• History of poor (< 4 oocytes) or hyper (> 25 oocytes) responses to FSH treatment at dose 150 IU and GnRH-antagonist (gonadotropin-releasing hormone) protocol

• Premature ovarian failure

• Ectopic pregnancy (3 month before the study cycle)

• Presence of clinically significant systemic disease

• Presence of chronic cardiovascular, hepatic, renal or pulmonary disease

• Presence of endocrine disorder

• Neoplasia

• Male infertility without mobile spermatozoa in the ejaculate, that need MESA (Microsurgical epididymal sperm aspiration)/TESE (testicular sperm extraction)/TESA (testicular sperm aspiration)

• Smoking > 10 cigarettes/day

• Narcomania, alcoholism

• Planned PGS (preimplantation genetic screeneing) /PGD (preimplantation genetic diagnosis)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Hospital Lapino	Moscow Oblast		Russian Federation
2	AltraVita IVF clinic	Moscow		Russian Federation
3	Perinatal Medical Center	Moscow		Russian Federation

Sponsors and Collaborators

• IVFarma LLC
• BridgePharm LLC
• GlobalPharma LLC

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 4, 2016

More Information

Additional Information:

• Abstracts of the 35th Annual Meeting of the ESHRE, Vienna, Austria 24 to 26 June 2019
• European Journal of Obstetrics & Gynecology and Reproductive Biology Volume 241, October 2019, Pages 6-12

Publications

None provided.

• Responsible Party: IVFarma LLC
• ClinicalTrials.gov Identifier: NCT03088137
• Other Study ID Numbers: FSG-03-01
• First Posted: Mar 23, 2017
• Last Update Posted: Apr 1, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by IVFarma LLC: in vitro fertilization
• Additional relevant MeSH terms: Infertility; Infertility, Female; Follicle Stimulating Hormone

Study Results

Participant Flow

Recruitment Details	Subjects were screened and enrolled at 3 In Vitro Fertilisation (IVF) centers in Russian Federation from 08.02.2017 - 17.08.2018.
Pre-assignment Detail	Of 118 participants: 8 were reported as screening failures prior the group assignment.

Arm/Group Title	Primapur (Follitropin Alfa)	Gonal-f (Follitropin Alfa)
Arm/Group Description	Follitropin alfa (Primapur): Subcutaneous injection (pen-injector), fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation	Follitropin alfa (Gonal-f): Subcutaneous injection (pen-injector), fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
Period Title: Overall Study
STARTED	55	55
COMPLETED	55	55
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Primapur (Follitropin Alfa)	Gonal-f (Follitropin Alfa)	Total
Arm/Group Description	Follitropin alfa (Primapur): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation	Follitropin alfa (Gonal-f): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation	Total of all reporting groups
Overall Participants	55	55	110
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	31.3 (2.68)	30.0 (2.71)	30.65 (2.75)
Sex: Female, Male (Count of Participants)
Female	55 100%	55 100%	110 100%
Male	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	55 100%	55 100%	110 100%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Russia	55 100%	55 100%	110 100%
Body Mass Index (BMI) (kg/m2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m2]	22.0 (2.69)	22.3 (3.06)	22.15 (2.87)
Duration of infertility (month) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [month]	46.4 (32.4)	36.9 (26.6)	41.65 (28.22)
Antral follicle (Number of antral follicles) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Number of antral follicles]	11.2 (3.2)	12.4 (2.4)	11.80 (2.87)
Anti-mullerian hormone (AMH) (ng per ml) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [ng per ml]	4.57 (2.96)	5.47 (3.82)	5.02 (3.43)
Follicle stimulating hormone (FSH) (IU/l) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [IU/l]	6.46 (1.86)	6.76 (1.89)	6.61 (1.87)
Estradiol (pg/ml) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [pg/ml]	35.87 (12.67)	33.82 (12.45)	34.85 (12.54)
Cause of infertility (Count of Participants)
Tubal factor	21 38.2%	18 32.7%	39 35.5%
Male factor	21 38.2%	27 49.1%	48 43.6%
Tubal and male factors	13 23.6%	10 18.2%	23 20.9%

Outcome Measures

1. Primary Outcome

Title	Oocytes (Intention-to-Treat, ITT)
Description	The total number of retrieved oocytes at the day of ovum pick-up. No more than 37 hours from the introduction of the trigger of ovulation (hCG or GnRH-agonist). The equivalence in the number of retrieved oocytes was tested using a predetermined equivalence margin of +/- 3.4 oocytes.
Time Frame	From date of randomization up to 18 days

Outcome Measure Data

Analysis Population Description

Intention-to-Treat

Arm/Group Title	Primapur (Follitropin Alfa)	Gonal-f (Follitropin Alfa)
Arm/Group Description	Follitropin alfa (Primapur): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation	Follitropin alfa (Gonal-f): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
Measure Participants	55	55
Mean (Standard Deviation) [Number of retrieved oocytes]	12.16 (7.28)	11.62 (6.29)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Primapur (Follitropin Alfa), Gonal-f (Follitropin Alfa)
	Comments
	Type of Statistical Test	Equivalence
	Comments	Study power of at least 80% at a significance level (alpha error) 5% and a pre-determined clinical equivalence margin of +/- 3.4 oocytes for the relevant population.
Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.546
	Confidence Interval	(2-Sided) 95%; -2.026 to 3.116
	Parameter Dispersion	Type: Standard Deviation; Value: 1.297
	Estimation Comments

2. Secondary Outcome

Title	Number of Follicles With Size ≥ 16 mm
Description	The number of follicles 16 mm or over in diameter at the day of hCG (or GnRH-agonist) administration
Time Frame	From date of randomization up to 16 days

Outcome Measure Data

Analysis Population Description

Intention-to-Treat

Arm/Group Title	Primapur (Follitropin Alfa)	Gonal-f (Follitropin Alfa)
Arm/Group Description	Follitropin alfa (Primapur): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation	Follitropin alfa (Gonal-f): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
Measure Participants	55	55
Mean (Standard Deviation) [Number of follicles]	12.09 (6.159)	11.38 (4.965)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Primapur (Follitropin Alfa), Gonal-f (Follitropin Alfa)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.806
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.709
	Confidence Interval	(2-Sided) 95%; -1.405 to 2.824
	Parameter Dispersion	Type: Standard Deviation; Value: 1.067
	Estimation Comments

3. Secondary Outcome

Title	Mature Oocytes
Description	The number of mature oocytes (MII stage of development)
Time Frame	From date of randomization up to 18 days

Outcome Measure Data

Analysis Population Description

Intention-to-Treat

Arm/Group Title	Primapur (Follitropin Alfa)	Gonal-f (Follitropin Alfa)
Arm/Group Description	Follitropin alfa (Primapur): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation	Follitropin alfa (Gonal-f): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
Measure Participants	55	55
Mean (Standard Deviation) [Number of mature oocytes (MII stage)]	9.64 (6.270)	9.86 (5.546)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Primapur (Follitropin Alfa), Gonal-f (Follitropin Alfa)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.617
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.218
	Confidence Interval	(2-Sided) 95%; -2.455 to 2.019
	Parameter Dispersion	Type: Standard Deviation; Value: 1.129
	Estimation Comments

4. Secondary Outcome

Title	Fertilised Oocytes
Description	The number of fertilised oocytes with the presence of two pronuclei: 2PN
Time Frame	From date of randomization up to 19 days

Outcome Measure Data

Analysis Population Description

Intention-to-Treat

Arm/Group Title	Primapur (Follitropin Alfa)	Gonal-f (Follitropin Alfa)
Arm/Group Description	Follitropin alfa (Primapur): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation	Follitropin alfa (Gonal-f): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
Measure Participants	55	55
Mean (Standard Deviation) [Number of oocytes with 2PN]	8.127 (6.608)	8.764 (5.850)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Primapur (Follitropin Alfa), Gonal-f (Follitropin Alfa)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.445
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.636
	Confidence Interval	(2-Sided) 95%; -2.995 to 1.723
	Parameter Dispersion	Type: Standard Deviation; Value: 1.190
	Estimation Comments

5. Secondary Outcome

Title	Percentage of Patients With Embryo Transfer
Description	The number of patients (and percentage) with embryo transfers on days 3 and 5 after ovum pick-up
Time Frame	From date of randomization up to 25 days

Outcome Measure Data

Analysis Population Description

Per Protocol

Arm/Group Title	Primapur (Follitropin Alfa)	Gonal-f (Follitropin Alfa)
Arm/Group Description	Follitropin alfa (Primapur): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation	Follitropin alfa (Gonal-f): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
Measure Participants	49	49
Embryo transfer on day 3 (%)	11 20%	9 16.4%
Embryo transfer on day 5 (%)	38 69.1%	40 72.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Primapur (Follitropin Alfa), Gonal-f (Follitropin Alfa)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.623
	Comments
	Method	ANOVA
	Comments

6. Secondary Outcome

Title	Total Dose of Follitropin Alfa
Description	The total dose of the follitropin alfa administrated during the ovarian hyperstimulation protocol (measured in International Units - IU)
Time Frame	From date of randomization up to 16 days

Outcome Measure Data

Analysis Population Description

Intention-to-Treat

Arm/Group Title	Primapur (Follitropin Alfa)	Gonal-f (Follitropin Alfa)
Arm/Group Description	Follitropin alfa (Primapur): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation	Follitropin alfa (Gonal-f): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
Measure Participants	55	55
Mean (Standard Deviation) [Total dose (IU)]	1532.7 (267.2)	1517.9 (255.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Primapur (Follitropin Alfa), Gonal-f (Follitropin Alfa)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.488
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	14.9
	Confidence Interval	(2-Sided) 95%; -83.9 to 113.6
	Parameter Dispersion	Type: Standard Deviation; Value: 49.8
	Estimation Comments

7. Secondary Outcome

Title	Number of Days of Follitropin Alfa Treatment
Description	The duration of ovarian hyperstimulation protocol (at the day of trigger of ovulation)
Time Frame	From date of randomization up to 16 days

Outcome Measure Data

Analysis Population Description

Intention-to-Treat

Arm/Group Title	Primapur (Follitropin Alfa)	Gonal-f (Follitropin Alfa)
Arm/Group Description	Follitropin alfa (Primapur): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation	Follitropin alfa (Gonal-f): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
Measure Participants	55	55
Mean (Standard Deviation) [Days]	9.745 (1.075)	9.727 (1.027)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Primapur (Follitropin Alfa), Gonal-f (Follitropin Alfa)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.629
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.018
	Confidence Interval	(2-Sided) 95%; -0.379 to 0.416
	Parameter Dispersion	Type: Standard Deviation; Value: 0.201
	Estimation Comments

8. Secondary Outcome

Title	Number of Patients With Follitropin Alfa Dose Correction
Description	The number of dose adjustments during the ovarian hyperstimulation protocol (increment 25-50 IU)
Time Frame	From date of randomization up to 16 days

Outcome Measure Data

Analysis Population Description

Intention-to-Treat

Arm/Group Title	Primapur (Follitropin Alfa)	Gonal-f (Follitropin Alfa)
Arm/Group Description	Follitropin alfa (Primapur): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation	Follitropin alfa (Gonal-f): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
Measure Participants	55	55
Count of Participants [Participants]	13 23.6%	11 20%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Primapur (Follitropin Alfa), Gonal-f (Follitropin Alfa)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.644
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

9. Secondary Outcome

Title	Number of Patients With Cycle Cancellation
Description	The number of the ovarian hyperstimulation protocol cancellation (at the day of trigger of ovulation)
Time Frame	From date of randomization up to 16 days

Outcome Measure Data

Analysis Population Description

Intention-to-Treat

Arm/Group Title	Primapur (Follitropin Alfa)	Gonal-f (Follitropin Alfa)
Arm/Group Description	Follitropin alfa (Primapur): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation	Follitropin alfa (Gonal-f): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
Measure Participants	55	55
Count of Participants [Participants]	0 0%	0 0%

10. Secondary Outcome

Title	Number of No-responders
Description	The number of patients with no response to follitropin alfa treatment (absence of growing follicles, no any oocytes obtained at the day of ovum pick-up)
Time Frame	From date of randomization up to 8 days

Outcome Measure Data

Analysis Population Description

Intention-to-Treat

Arm/Group Title	Primapur (Follitropin Alfa)	Gonal-f (Follitropin Alfa)
Arm/Group Description	Follitropin alfa (Primapur): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation	Follitropin alfa (Gonal-f): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
Measure Participants	55	55
Count of Participants [Participants]	0 0%	0 0%

11. Secondary Outcome

Title	Percentage of Patients With Serum hCG More Than 25 IU/l
Description	Biochemical pregnancy test: serum hCG more than 25 IU/l (days 12-17 after embryo transfer)
Time Frame	From date of randomization up to 42 days

Outcome Measure Data

Analysis Population Description

Per Protocol

Arm/Group Title	Primapur (Follitropin Alfa)	Gonal-f (Follitropin Alfa)
Arm/Group Description	Follitropin alfa (Primapur): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation	Follitropin alfa (Gonal-f): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
Measure Participants	49	49
Number (95% Confidence Interval) [Percentage of patients (%)]	34.7	36.7

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Primapur (Follitropin Alfa), Gonal-f (Follitropin Alfa)
	Comments	95% confidence intervals (CIs) of point estimates were calculated using the exact binomial distribution (Clopper-Pearson method) for proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.833
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-2.0
	Confidence Interval	(2-Sided) 95%; -21.0 to 17.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

12. Secondary Outcome

Title	Percentage of Patients With the Evidence for Clinical Pregnancy
Description	Confirmation of clinical pregnancy: ultrasound detection of intrauterine gestational sac and heart activity
Time Frame	The 10th week after embryo transfer

Outcome Measure Data

Analysis Population Description

Per Protocol

Arm/Group Title	Primapur (Follitropin Alfa)	Gonal-f (Follitropin Alfa)
Arm/Group Description	Follitropin alfa (Primapur): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation	Follitropin alfa (Gonal-f): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
Measure Participants	49	49
Number (95% Confidence Interval) [Percentage of patients (%)]	26.5	32.7

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Primapur (Follitropin Alfa), Gonal-f (Follitropin Alfa)
	Comments	95% confidence intervals (CIs) of point estimates were calculated using the exact binomial distribution (Clopper-Pearson method) for proportions.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.507
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.62
	Confidence Interval	(2-Sided) 95%; -24.3 to 11.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	1 year, 6 month
Arm/Group Title	Primapur (Follitropin Alfa)		Gonal-f (Follitropin Alfa)
Arm/Group Description	Follitropin alfa (Primapur): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation		Follitropin alfa (Gonal-f): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
All Cause Mortality
	Primapur (Follitropin Alfa)		Gonal-f (Follitropin Alfa)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/55 (0%)		0/55 (0%)
Serious Adverse Events
	Primapur (Follitropin Alfa)		Gonal-f (Follitropin Alfa)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/55 (3.6%)		2/55 (3.6%)
Injury, poisoning and procedural complications
Iatrogenic injury	1/55 (1.8%)	1	0/55 (0%)	0
Pregnancy, puerperium and perinatal conditions
Threatened miscarriage	1/55 (1.8%)	1	0/55 (0%)	0
Reproductive system and breast disorders
Ovarian hyperstymulation syndrome	0/55 (0%)	0	2/55 (3.6%)	2
Other (Not Including Serious) Adverse Events
	Primapur (Follitropin Alfa)		Gonal-f (Follitropin Alfa)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	21/55 (38.2%)		13/55 (23.6%)
Cardiac disorders
Sternum pain	1/55 (1.8%)	1	0/55 (0%)	0
Palpitations	1/55 (1.8%)	1	0/55 (0%)	0
Investigations
Laboratory investigations	1/55 (1.8%)	1	0/55 (0%)	0
Musculoskeletal and connective tissue disorders
Fatigue	1/55 (1.8%)	1	0/55 (0%)	0
Nervous system disorders
Drowsiness	1/55 (1.8%)	1	0/55 (0%)	0
Pregnancy, puerperium and perinatal conditions
Spontaneous miscarriage	0/55 (0%)	0	2/55 (3.6%)	2
Early Toxicosis During Pregnancy	0/55 (0%)	0	1/55 (1.8%)	1
Abnormal vaginal bleeding	0/55 (0%)	0	1/55 (1.8%)	1
Spotting	1/55 (1.8%)	1	1/55 (1.8%)	1
Lower abdominal pain	2/55 (3.6%)	2	4/55 (7.3%)	4
Reproductive system and breast disorders
Menses	0/55 (0%)	0	1/55 (1.8%)	1
Ovarian hyperstimulation syndrome	4/55 (7.3%)	4	2/55 (3.6%)	2
Decrease in breast sensitivity	2/55 (3.6%)	2	0/55 (0%)	0
Lower abdominal pain	3/55 (5.5%)	3	1/55 (1.8%)	1
Pains in the lower abdomen	1/55 (1.8%)	1	0/55 (0%)	0
Abnormal vaginal bleeding	3/55 (5.5%)	3	1/55 (1.8%)	1
Spotting	2/55 (3.6%)	2	0/55 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.