Trial Outcomes & Findings for Predictive Factors for Ovarian Stimulation Using a Fixed Daily Dose of 200 IU Recombinant FSH (Study 142003)(P05696) (NCT NCT00778999)
NCT ID: NCT00778999
Last Updated: 2022-02-04
Results Overview
The total number of oocytes on the Day of oocyte pick-up is an indication of ovarian response
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
442 participants
Primary outcome timeframe
12 weeks
Results posted on
2022-02-04
Participant Flow
Participant milestones
| Measure |
Oral Contraceptive
Use of oral contraceptive pills prior to controlled ovarian stimulation
|
Non-Oral Contraceptive
No use of oral contraceptive pills prior to controlled ovarian stimulation
|
|---|---|---|
|
Overall Study
STARTED
|
223
|
219
|
|
Overall Study
COMPLETED
|
195
|
185
|
|
Overall Study
NOT COMPLETED
|
28
|
34
|
Reasons for withdrawal
| Measure |
Oral Contraceptive
Use of oral contraceptive pills prior to controlled ovarian stimulation
|
Non-Oral Contraceptive
No use of oral contraceptive pills prior to controlled ovarian stimulation
|
|---|---|---|
|
Overall Study
Discontinuation: no embryo transfer
|
14
|
14
|
|
Overall Study
Did not receive recFSH
|
14
|
20
|
Baseline Characteristics
Predictive Factors for Ovarian Stimulation Using a Fixed Daily Dose of 200 IU Recombinant FSH (Study 142003)(P05696)
Baseline characteristics by cohort
| Measure |
Oral Contraceptive
n=223 Participants
Use of oral contraceptive pills prior to controlled ovarian stimulation
|
Non-Oral Contraceptive
n=219 Participants
No use of oral contraceptive pills prior to controlled ovarian stimulation
|
Total
n=442 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
223 Participants
n=93 Participants
|
219 Participants
n=4 Participants
|
442 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
223 Participants
n=93 Participants
|
219 Participants
n=4 Participants
|
442 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Intent-to-treat, defined as all randomized subjects who received recombinant follicle stimulating hormone
The total number of oocytes on the Day of oocyte pick-up is an indication of ovarian response
Outcome measures
| Measure |
Oral Contraceptive
n=209 Participants
Use of oral contraceptive pills prior to controlled ovarian stimulation
|
Non-Oral Contraceptive
n=199 Participants
No use of oral contraceptive pills prior to controlled ovarian stimulation
|
|---|---|---|
|
Total Number of Oocytes
|
12.4 Number of oocytes
Standard Deviation 6.7
|
12.1 Number of oocytes
Standard Deviation 7.7
|
SECONDARY outcome
Timeframe: 12 weeksThis is not a prespecified key secondary outcome; therefore, results will not be disclosed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksThis is not a prespecified key secondary outcome; therefore, results will not be disclosed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksThis is not a prespecified key secondary outcome; therefore, results will not be disclosed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksThis is not a prespecified key secondary outcome; therefore, results will not be disclosed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksThis is not a prespecified key secondary outcome; therefore, results will not be disclosed.
Outcome measures
Outcome data not reported
Adverse Events
Oral Contraceptive
Serious events: 10 serious events
Other events: 88 other events
Deaths: 0 deaths
Non-Oral Contraceptive
Serious events: 9 serious events
Other events: 81 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Oral Contraceptive
n=209 participants at risk
Use of oral contraceptive pills prior to controlled ovarian stimulation
|
Non-Oral Contraceptive
n=199 participants at risk
No use of oral contraceptive pills prior to controlled ovarian stimulation
|
|---|---|---|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.48%
1/209 • Number of events 1
|
0.00%
0/199
|
|
Gastrointestinal disorders
Pancreatitis
|
0.48%
1/209 • Number of events 1
|
0.00%
0/199
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/209
|
0.50%
1/199 • Number of events 1
|
|
Pregnancy, puerperium and perinatal conditions
Antepartum haemorrhage
|
0.48%
1/209 • Number of events 1
|
0.00%
0/199
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.96%
2/209 • Number of events 2
|
1.0%
2/199 • Number of events 2
|
|
Pregnancy, puerperium and perinatal conditions
Retroplacental haematoma
|
0.48%
1/209 • Number of events 1
|
0.50%
1/199 • Number of events 1
|
|
Pregnancy, puerperium and perinatal conditions
Ruptured ectopic pregnancy
|
0.96%
2/209 • Number of events 2
|
0.50%
1/199 • Number of events 1
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/209
|
0.50%
1/199 • Number of events 1
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
0.48%
1/209 • Number of events 1
|
0.00%
0/199
|
|
Reproductive system and breast disorders
Ovarian hyperstimulation syndrome
|
0.96%
2/209 • Number of events 2
|
1.5%
3/199 • Number of events 3
|
|
Surgical and medical procedures
Abortion induced
|
0.48%
1/209 • Number of events 1
|
0.00%
0/199
|
Other adverse events
| Measure |
Oral Contraceptive
n=209 participants at risk
Use of oral contraceptive pills prior to controlled ovarian stimulation
|
Non-Oral Contraceptive
n=199 participants at risk
No use of oral contraceptive pills prior to controlled ovarian stimulation
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
3.8%
8/209 • Number of events 8
|
7.5%
15/199 • Number of events 18
|
|
Injury, poisoning and procedural complications
Procedural pain
|
25.4%
53/209 • Number of events 55
|
22.6%
45/199 • Number of events 45
|
|
Nervous system disorders
Headache
|
8.1%
17/209 • Number of events 23
|
6.0%
12/199 • Number of events 12
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
3.8%
8/209 • Number of events 8
|
6.0%
12/199 • Number of events 12
|
|
Pregnancy, puerperium and perinatal conditions
Antepartum haemorrhage
|
5.3%
11/209 • Number of events 14
|
4.5%
9/199 • Number of events 13
|
|
Reproductive system and breast disorders
Ovarian hyperstimulation syndrome
|
2.4%
5/209 • Number of events 5
|
5.5%
11/199 • Number of events 11
|
|
Reproductive system and breast disorders
Pelvic discomfort
|
9.6%
20/209 • Number of events 21
|
7.0%
14/199 • Number of events 16
|
|
Reproductive system and breast disorders
Pelvic pain
|
8.6%
18/209 • Number of events 20
|
7.0%
14/199 • Number of events 14
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor recognizes the right of the investigator(s) to publish, but all communication concerning the clinical trial must be based on data validated and released and will first be submitted to the Sponsor for written consent, which shall not be withheld unreasonably. Sponsor is free to use the data for publication. The investigator(s) may be invited to be co-author(s). In any communication concerning this clinical trial, the author(s) of this protocol will be included in the list of authors.
- Publication restrictions are in place
Restriction type: OTHER