A Study to Assess the Efficacy and Safety of Ganirelix (Orgalutran®) Treatment in Chinese Women Undergoing Controlled Ovarian Stimulation for in Vitro Fertilization (IVF) or Intra Cytoplasmatic Sperm Injection (ICSI) (Study 38651)(P05703)

• Sponsor: Organon and Co (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00725491
• Collaborator: (none)
• Enrollment: 259
• Arms: 2
• Duration (Months): 19.1

Study Details

Study Description

Brief Summary

The primary purpose of this study is to assess that ganirelix is safe and well-tolerated in Chinese women and that a controlled ovarian stimulation (COS) protocol combining recombinant follicle stimulating hormone (recFSH) with ganirelix is efficient in Chinese women undergoing COS for in vitro fertilization (IVF) or intra cytoplasmatic sperm injection (ICSI).

Condition or Disease	Intervention/Treatment	Phase
Controlled Ovarian Stimulation	Drug: ganirelix; Drug: triptorelin	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 259 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase III, Multi-center, Open-label, Randomized Study to Assess the Efficacy and Safety of Org 37462 Treatment in Chinese Women Undergoing Controlled Ovarian Stimulation for IVF or ICSI, Using a Long Protocol of Triptorelin as a Reference Treatment.
• Study Start Date: May 1, 2007
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 ganirelix	Drug: ganirelix; On day 6 of recFSH treatment, Org 37462 treatment will start by daily SC administration (0.25 mg) up to and including the day of hCG administration.; Other Names: Orgalutran® Org 37462
Active Comparator: 2 triptorelin	Drug: triptorelin; a daily dose of 0.05 mg SC is to be injected. Triptorelin treatment will start in the luteal phase at day 21-24 of the menstrual cycle. Treatment with recFSH will start 14 days later if treatment with triptorelin has resulted in downregulation, i.e. serum E2 <= 50 pg/ml (<= 200pmol/l). In case the hypogonadotropic state is not reached after 14 days of pretreatment, the dose of triptorelin will be increased to 0.1 mg. If downregulation is not reached within 28 days of pre-treatment with triptorelin, the subject will be discontinued from further hormonal treatment. The daily dose of triptorelin is sustained up to and including the day of hCG.; Other Names: Decapeptyl

Outcome Measures

Primary Outcome Measures

1. The Amount of International Units (IU) of Recombinant Follicle Stimulating Hormone (recFSH) Needed in a Controlled Ovarian Stimulation (COS) Cycle up to the First Day the Human Chorionic Gonadotropin (hCG) Criterion is Met. [At completion of ovarian stimulation; maximally after 18 days of recFSH administration.]

   The hCG criterion is met the first day that 3 follicles >= 17 mm are observed.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• females of infertile couples for whom COS and IVF or ICSI is indicated

• body mass index between 18 and 29 kg/m2

• willing and able to give written informed consent.

Exclusion Criteria:

• More than three previous COS cycles for assisted reproduction since last established ongoing pregnancy (if applicable)

• History of no or low ovarian response to FSH/human menopausal gonadotropin (hMG) treatment

• Less than 2 ovaries or any other ovarian abnormality including endometrioma

• Presence of unilateral or bilateral hydrosalpinx

• Any ovarian and/or abdominal abnormality that would interfere with adequate ultrasound investigation of at least one ovary

• History of or current polycystic ovary syndrome (PCOS)

• History of/or current endocrine abnormality

• Any clinically relevant hormone value outside the reference range during the early follicular phase

• Any clinically significant abnormal laboratory value

• Hypertension or currently treated hypertension

• Recent history of current epilepsy, diabetes, cardiovascular, gastro-intestinal, hepatic, renal, pulmonary disease

• Alcohol or drug abuse, or history thereof

• Current serious allergic symptoms

• Abnormal cervical smear

• Known hypersensitivity to gonadotropin releasing hormone (GnRH) or its analogs;

• Contra-indications for the use of gonadotropins

• Use of hormonal preparations within 1 month prior to the date of signing consent;

• Administration of any investigational product within 3 months prior to screening.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Organon and Co

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Organon and Co
• ClinicalTrials.gov Identifier: NCT00725491
• Other Study ID Numbers: P05703; 38651
• First Posted: Jul 30, 2008
• Last Update Posted: Feb 3, 2022
• Last Verified: Feb 1, 2022

• Keywords provided by Organon and Co: Reproductive; techniques; assisted
• Additional relevant MeSH terms: Triptorelin Pamoate; Ganirelix

Study Results

Participant Flow

Arm/Group Title	Ganirelix	Triptorelin
Arm/Group Description	0.25 mg once daily from stimulation day 6 onwards up to the day of human chorionic gonadotropin (hCG).	0.05 mg once daily from cycle day 21-24 onwards up to the day of hCG
Period Title: Overall Study
STARTED	113	120
COMPLETED	104	102
NOT COMPLETED	9	18

Baseline Characteristics

Arm/Group Title	Ganirelix	Triptorelin	Total
Arm/Group Description	0.25 mg once daily from stimulation day 6 onwards up to the day of human chorionic gonadotropin (hCG).	0.05 mg once daily from cycle day 21-24 onwards up to the day of hCG	Total of all reporting groups
Overall Participants	113	120	233
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	29.3 (2.8)	29.1 (3.0)	29.2 (2.9)
Sex: Female, Male (Count of Participants)
Female	113 100%	120 100%	233 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
China	113 100%	120 100%	233 100%

Outcome Measures

1. Primary Outcome

Title	The Amount of International Units (IU) of Recombinant Follicle Stimulating Hormone (recFSH) Needed in a Controlled Ovarian Stimulation (COS) Cycle up to the First Day the Human Chorionic Gonadotropin (hCG) Criterion is Met.
Description	The hCG criterion is met the first day that 3 follicles >= 17 mm are observed.
Time Frame	At completion of ovarian stimulation; maximally after 18 days of recFSH administration.

Outcome Measure Data

Analysis Population Description

The number of participants for this analysis included only those participants in the intent-to-treat (ITT) group who received hCG and for whom data was available.

Arm/Group Title	Ganirelix	Triptorelin
Arm/Group Description	0.25 mg once daily from stimulation day 6 onwards up to the day of human chorionic gonadotropin (hCG).	0.05 mg once daily from cycle day 21-24 onwards up to the day of hCG
Measure Participants	109	114
Mean (Standard Deviation) [international units (IU)]	1272.0 (265.8)	1415.6 (355.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ganirelix, Triptorelin
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Cochran-Whitehead
	Comments

Adverse Events

Adverse Event Reporting Description	One subject in the ganirelix group started ovarian stimulation with recFSH but was never treated with ganirelix.
Arm/Group Title	Ganirelix		Triptorelin
Arm/Group Description	0.25 mg once daily from stimulation day 6 onwards up to the day of human chorionic gonadotropin (hCG).		0.05 mg once daily from cycle day 21-24 onwards up to the day of hCG
All Cause Mortality
	Ganirelix		Triptorelin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Ganirelix		Triptorelin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/112 (3.6%)		2/120 (1.7%)
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous	1/112 (0.9%)	1	0/120 (0%)	0
Ectopic pregnancy	2/112 (1.8%)	2	0/120 (0%)	0
Reproductive system and breast disorders
Ovarian hyperstimulation syndrome	1/112 (0.9%)	1	2/120 (1.7%)	2
Other (Not Including Serious) Adverse Events
	Ganirelix		Triptorelin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	13/112 (11.6%)		13/120 (10.8%)
Gastrointestinal disorders
Nausea	9/112 (8%)	9	11/120 (9.2%)	11
Vomiting	6/112 (5.4%)	6	7/120 (5.8%)	7
Pregnancy, puerperium and perinatal conditions
Antepartum haemorrhage	6/112 (5.4%)	6	5/120 (4.2%)	5

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The sponsor can review any scientific paper, presentation, or other communication concerning the clinical trial at least 6 weeks ahead of estimated publication or presentation. In order to protect its proprietary interests, the sponsor shall have the right to make its consent, which shall not be withheld unreasonably, conditional upon proper representation of the interpretation of both the sponsor and the investigator(s) in the discussion of the data in such communications.