Trial Outcomes & Findings for Follow-up Study of Frozen-thawed Embryo Transfer (FTET) Cycles After Cryopreservation of Embryos in Clinical Trial P05787 (P05716) (NCT NCT00702273)
NCT ID: NCT00702273
Last Updated: 2024-09-05
Results Overview
An ongoing pregnancy is the presence of at least one fetus with heart activity at least 10 weeks after embryo transfer or confirmed by live birth.The cumulative ongoing pregnancy rate is 100 times the number of participants with an ongoing pregnancy either immediately after embryo transfer in base Trial P05787 (NCT00696800), or after one or more FTET cycles in follow-up Trial P05716 following cryopreservation, divided by the total number of participants that started treatment in base Trial P05787 (NCT00696800). Participants who did not have cryopreserved embryos, or embryo transfers in the FTET cycle(s), were considered 'not pregnant'.
Recruitment status
COMPLETED
Target enrollment
344 participants
Primary outcome timeframe
Up to 1 year after embryo transfer in base trial P05787 (NCT00696800), and FTET cycles in follow up trial
Results posted on
2024-09-05
Participant Flow
Period one consists of participants from the base study P05787 (NCT00696800), randomized to treatment groups Corifollitropin Alfa (Cori Alfa) (Org 36286) or recombinant Follicle Stimulating Hormone (recFSH). Period two consists of eligible participants (N = 344) from the base study who enrolled in the follow up study P05716.
Participant milestones
| Measure |
150 µg Corifollitropin Alfa
Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG). Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles \>= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent frozen thawed embryo transfer (FTET) cycles.
|
200 IU RecFSH
Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Multiple daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles \>= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
|
|---|---|---|
|
Base Study P05787 (NCT00696800)
STARTED
|
757
|
752
|
|
Base Study P05787 (NCT00696800)
Treated
|
756
|
750
|
|
Base Study P05787 (NCT00696800)
COMPLETED
|
672
|
704
|
|
Base Study P05787 (NCT00696800)
NOT COMPLETED
|
85
|
48
|
|
Follow Up Study P05716 (NCT00702273)
STARTED
|
168
|
176
|
|
Follow Up Study P05716 (NCT00702273)
COMPLETED
|
148
|
147
|
|
Follow Up Study P05716 (NCT00702273)
NOT COMPLETED
|
20
|
29
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Follow-up Study of Frozen-thawed Embryo Transfer (FTET) Cycles After Cryopreservation of Embryos in Clinical Trial P05787 (P05716)
Baseline characteristics by cohort
| Measure |
150 µg Corifollitropin Alfa
n=168 Participants
Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG). Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles \>= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
|
200 IU RecFSH
n=176 Participants
Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Multiple daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles \>= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
|
Total
n=344 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.1 Years
STANDARD_DEVIATION 3.8 • n=99 Participants
|
31.3 Years
STANDARD_DEVIATION 3.0 • n=107 Participants
|
31.2 Years
STANDARD_DEVIATION 3.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
168 Participants
n=99 Participants
|
176 Participants
n=107 Participants
|
344 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 1 year after embryo transfer in base trial P05787 (NCT00696800), and FTET cycles in follow up trialPopulation: ITT group from base trial P05787, consisting of randomized participants who were treated with Corifollitropin Alfa or recFSH.
An ongoing pregnancy is the presence of at least one fetus with heart activity at least 10 weeks after embryo transfer or confirmed by live birth.The cumulative ongoing pregnancy rate is 100 times the number of participants with an ongoing pregnancy either immediately after embryo transfer in base Trial P05787 (NCT00696800), or after one or more FTET cycles in follow-up Trial P05716 following cryopreservation, divided by the total number of participants that started treatment in base Trial P05787 (NCT00696800). Participants who did not have cryopreserved embryos, or embryo transfers in the FTET cycle(s), were considered 'not pregnant'.
Outcome measures
| Measure |
150 µg Corifollitropin Alfa
n=756 Participants
Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG). Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles \>= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
|
200 IU RecFSH
n=750 Participants
Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Multiple daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles \>= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
|
|---|---|---|
|
Percentage of Participants With an Ongoing Pregnancy (Cumulative Ongoing Pregnancy Rate)
|
47.2 Percentage of participants
|
44.9 Percentage of participants
|
SECONDARY outcome
Timeframe: After one or more FTET cycles, up to day of miscarriage (up to 1 year)Population: Participants enrolled in P05716 Follow Up study that had a clinical pregnancy.
Miscarriages were calculated per clinical pregnancy, meaning the presence of at least one gestational sac or confirmed by live birth.
Outcome measures
| Measure |
150 µg Corifollitropin Alfa
n=73 Participants
Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG). Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles \>= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
|
200 IU RecFSH
n=68 Participants
Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Multiple daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles \>= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
|
|---|---|---|
|
Percentage of Participants in Follow up Trial With a Miscarriage Per Clinical Pregnancy
|
8.2 Percentage of participants
|
17.6 Percentage of participants
|
SECONDARY outcome
Timeframe: After one or more FTET cycles, up to day of miscarriage (up to 1 year)Population: Participants enrolled in P05716 Follow Up study that had a vital pregnancy.
Miscarriages were calculated per vital pregnancy, meaning the presence of at least one fetus with heart activity.
Outcome measures
| Measure |
150 µg Corifollitropin Alfa
n=67 Participants
Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG). Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles \>= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
|
200 IU RecFSH
n=56 Participants
Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Multiple daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles \>= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
|
|---|---|---|
|
Percentage of Participants in Follow up Trial With a Miscarriage Per Vital Pregnancy
|
0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)Population: Participants enrolled in P05716 Follow Up study.
An ectopic pregnancy is where the embryo implants outside the uterus. Ectopic pregnancies were calculated per total number of participants started in FTET.
Outcome measures
| Measure |
150 µg Corifollitropin Alfa
n=168 Participants
Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG). Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles \>= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
|
200 IU RecFSH
n=176 Participants
Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Multiple daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles \>= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
|
|---|---|---|
|
Percentage of Participants in Follow up Trial With an Ectopic Pregnancy
|
1.2 Percentage of participants
|
0.6 Percentage of participants
|
SECONDARY outcome
Timeframe: After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)Population: Participants enrolled in P05716 Follow Up study, that had an embryo transfer in the respective cycle.
A clinical pregnancy is the presence of at least gestational sac or confirmed by live birth. Clinical pregnancies were calculated per attempt, meaning if any stage of in vitro fertilization (IVF) treatment was not achieved, zero values were imputed.
Outcome measures
| Measure |
150 µg Corifollitropin Alfa
n=168 Participants
Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG). Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles \>= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
|
200 IU RecFSH
n=176 Participants
Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Multiple daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles \>= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
|
|---|---|---|
|
Percentage of Participants in Follow up Trial With a Clinical Pregnancy
|
43.5 Percentage of participants
|
38.6 Percentage of participants
|
SECONDARY outcome
Timeframe: After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)Population: Participants enrolled in P05716 Follow Up study, that had an embryo transfer in the respective cycle.
A vital pregnancy is the presence of at least one fetus with heart activity. Vital pregnancies were calculated per attempt, meaning if any stage of IVF treatment was not achieved, zero values were imputed.
Outcome measures
| Measure |
150 µg Corifollitropin Alfa
n=168 Participants
Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG). Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles \>= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
|
200 IU RecFSH
n=176 Participants
Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Multiple daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles \>= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
|
|---|---|---|
|
Percentage of Participants in Follow up Trial With a Vital Pregnancy
|
39.9 Percentage of participants
|
31.8 Percentage of participants
|
SECONDARY outcome
Timeframe: After one or more FTET, assessed at least 10 weeks after embryo transfer or at live birth (up to 1 year)Population: Participants enrolled in P05716 Follow Up study, that had an embryo transfer in the respective cycle.
An ongoing pregnancy is the presence of at least one fetus with heart activity at least 10 weeks after embryo transfer or confirmed at live birth. Ongoing pregnancies were calculated per attempt, meaning if any stage of IVF treatment was not achieved, zero values were imputed.
Outcome measures
| Measure |
150 µg Corifollitropin Alfa
n=168 Participants
Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG). Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles \>= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
|
200 IU RecFSH
n=176 Participants
Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Multiple daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles \>= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
|
|---|---|---|
|
Percentage of Participants in Follow up Trial With an Ongoing Pregnancy
|
38.7 Percentage of participants
|
30.7 Percentage of participants
|
Adverse Events
150 µg Corifollitropin Alfa
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
200 IU RecFSH
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
150 µg Corifollitropin Alfa
n=168 participants at risk
Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG). Daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles \>= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started, for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
|
200 IU RecFSH
n=176 participants at risk
Participants from the base study P05787 (NCT00696800), received a single SC injection of placebo Corifollitropin Alfa on menstrual cycle day 2/3 (Day 1); 7 daily SC injections with 200 IU recFSH from Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Multiple daily SC injections of Ganirelix were given from Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles \>= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the base study were enrolled in follow up study P05716, where no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.60%
1/168 • Number of events 1
Participants who enrolled in Trial P05716 Follow Up. Trial P05716 did not systematically collect Serious Adverse Events (SAEs) or AEs. Instead any reported AEs were unsolicited and non-systematically assessed. Ectopic pregnancies in Outcome Measure 4 were collected as an efficacy rather than a safety endpoint; and were therefore not counted as AEs.
|
0.00%
0/176
Participants who enrolled in Trial P05716 Follow Up. Trial P05716 did not systematically collect Serious Adverse Events (SAEs) or AEs. Instead any reported AEs were unsolicited and non-systematically assessed. Ectopic pregnancies in Outcome Measure 4 were collected as an efficacy rather than a safety endpoint; and were therefore not counted as AEs.
|
Other adverse events
Adverse event data not reported
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Any scientific paper, presentation, or other communication concerning the clinical trial will first be submitted to the Sponsor, at least six weeks ahead of estimated publication or presentation, for written consent, which shall not be withheld unreasonably. The Sponsor shall have the right to make its consent 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