Trial Outcomes & Findings for 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) (NCT NCT00725491)
NCT ID: NCT00725491
Last Updated: 2022-02-03
Results Overview
The hCG criterion is met the first day that 3 follicles \>= 17 mm are observed.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
259 participants
Primary outcome timeframe
At completion of ovarian stimulation; maximally after 18 days of recFSH administration.
Results posted on
2022-02-03
Participant Flow
Participant milestones
| Measure |
Ganirelix
0.25 mg once daily from stimulation day 6 onwards up to the day of human chorionic gonadotropin (hCG).
|
Triptorelin
0.05 mg once daily from cycle day 21-24 onwards up to the day of hCG
|
|---|---|---|
|
Overall Study
STARTED
|
113
|
120
|
|
Overall Study
COMPLETED
|
104
|
102
|
|
Overall Study
NOT COMPLETED
|
9
|
18
|
Reasons for withdrawal
| Measure |
Ganirelix
0.25 mg once daily from stimulation day 6 onwards up to the day of human chorionic gonadotropin (hCG).
|
Triptorelin
0.05 mg once daily from cycle day 21-24 onwards up to the day of hCG
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
2
|
|
Overall Study
Pregnancy
|
0
|
3
|
|
Overall Study
Risk for hyperstimulation
|
2
|
9
|
|
Overall Study
No/too few oocytes/bad quality oocytes
|
1
|
1
|
|
Overall Study
Fertilization failure
|
0
|
1
|
|
Overall Study
No/too few embryos/ bad quality embryos
|
3
|
2
|
Baseline Characteristics
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)
Baseline characteristics by cohort
| Measure |
Ganirelix
n=113 Participants
0.25 mg once daily from stimulation day 6 onwards up to the day of human chorionic gonadotropin (hCG).
|
Triptorelin
n=120 Participants
0.05 mg once daily from cycle day 21-24 onwards up to the day of hCG
|
Total
n=233 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.3 years
STANDARD_DEVIATION 2.8 • n=5 Participants
|
29.1 years
STANDARD_DEVIATION 3.0 • n=7 Participants
|
29.2 years
STANDARD_DEVIATION 2.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
113 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
233 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
113 participants
n=5 Participants
|
120 participants
n=7 Participants
|
233 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At completion of ovarian stimulation; maximally after 18 days of recFSH administration.Population: 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.
The hCG criterion is met the first day that 3 follicles \>= 17 mm are observed.
Outcome measures
| Measure |
Ganirelix
n=109 Participants
0.25 mg once daily from stimulation day 6 onwards up to the day of human chorionic gonadotropin (hCG).
|
Triptorelin
n=114 Participants
0.05 mg once daily from cycle day 21-24 onwards up to the day of hCG
|
|---|---|---|
|
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.
|
1272.0 international units (IU)
Standard Deviation 265.8
|
1415.6 international units (IU)
Standard Deviation 355.6
|
Adverse Events
Ganirelix
Serious events: 4 serious events
Other events: 13 other events
Deaths: 0 deaths
Triptorelin
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ganirelix
n=112 participants at risk
0.25 mg once daily from stimulation day 6 onwards up to the day of human chorionic gonadotropin (hCG).
|
Triptorelin
n=120 participants at risk
0.05 mg once daily from cycle day 21-24 onwards up to the day of hCG
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.89%
1/112 • Number of events 1
One subject in the ganirelix group started ovarian stimulation with recFSH but was never treated with ganirelix.
|
0.00%
0/120
One subject in the ganirelix group started ovarian stimulation with recFSH but was never treated with ganirelix.
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
1.8%
2/112 • Number of events 2
One subject in the ganirelix group started ovarian stimulation with recFSH but was never treated with ganirelix.
|
0.00%
0/120
One subject in the ganirelix group started ovarian stimulation with recFSH but was never treated with ganirelix.
|
|
Reproductive system and breast disorders
Ovarian hyperstimulation syndrome
|
0.89%
1/112 • Number of events 1
One subject in the ganirelix group started ovarian stimulation with recFSH but was never treated with ganirelix.
|
1.7%
2/120 • Number of events 2
One subject in the ganirelix group started ovarian stimulation with recFSH but was never treated with ganirelix.
|
Other adverse events
| Measure |
Ganirelix
n=112 participants at risk
0.25 mg once daily from stimulation day 6 onwards up to the day of human chorionic gonadotropin (hCG).
|
Triptorelin
n=120 participants at risk
0.05 mg once daily from cycle day 21-24 onwards up to the day of hCG
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
8.0%
9/112 • Number of events 9
One subject in the ganirelix group started ovarian stimulation with recFSH but was never treated with ganirelix.
|
9.2%
11/120 • Number of events 11
One subject in the ganirelix group started ovarian stimulation with recFSH but was never treated with ganirelix.
|
|
Gastrointestinal disorders
Vomiting
|
5.4%
6/112 • Number of events 6
One subject in the ganirelix group started ovarian stimulation with recFSH but was never treated with ganirelix.
|
5.8%
7/120 • Number of events 7
One subject in the ganirelix group started ovarian stimulation with recFSH but was never treated with ganirelix.
|
|
Pregnancy, puerperium and perinatal conditions
Antepartum haemorrhage
|
5.4%
6/112 • Number of events 6
One subject in the ganirelix group started ovarian stimulation with recFSH but was never treated with ganirelix.
|
4.2%
5/120 • Number of events 5
One subject in the ganirelix group started ovarian stimulation with recFSH but was never treated with ganirelix.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER