An observational study in In Vitro Fertilization, sponsored by Organon and Co. Completed. Open to female participants aged 18 Years to 36 Years. Per ClinicalTrials.gov, last updated 2024-09-05.
Sponsored by Organon and Co · Observational
To collect the outcome of frozen-thawed embryo transfer cycles after the embryos are cryopreserved up to at least 1 year in Trial P05787 (NCT00696800), in order to estimate the cumulative pregnancy rate for each treatment group.
This is a follow-up protocol to collect the outcome of frozen-thawed embryo transfer cycles, performed after the embryos are cryopreserved up to at least 1 year in Trial P05787 (NCT00696800), to enable estimation of the cumulative pregnancy rate for each treatment group.
Organon and Co is the lead sponsor of 478 studies on the registry; none are open to participants now.
Of its 21 completed or terminated interventional studies of FDA-regulated products, 17 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Women from whom embryos have been cryopreserved in Base Trial P05787 (NCT00696800).
Exclusion Criteria:
Participants from the base study P05787 (NCT00696800), received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa (Org 36286) on menstrual cycle Day 2/3 (Day 1); 7 daily SC injections from Days 1 to 7 with placebo-recombinant Follicle Stimulating Hormone (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.
Drug: 150 µg Corifollitropin Alfa · Drug: Placebo for RecFSH/Follitropin beta · Biological: 200 IU RecFSH/Follitropin beta (Days 8 to hCG) · Drug: Ganirelix · Biological: hCG · Biological: Progesterone
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.
Biological: 200 IU RecFSH/Follitropin beta (Days 1 to 7) · Drug: Placebo for Corifollitropin Alfa · Biological: 200 IU RecFSH/Follitropin beta (Days 8 to hCG) · Drug: Ganirelix · Biological: hCG · Biological: Progesterone
On the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection of 150 μg (0.5 mL) Corifollitropin Alfa was administered in the abdominal wall.
Daily SC injections with 200 IU fixed dose recFSH were started on Stimulation Day 1 and continued up to and including Stimulation Day 7.
Pre-filled syringe containing an identical solution when compared to Corifollitropin Alfa. On the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection was administered in the abdominal wall.
Identical ready-for-use solution, but without the active ingredient, supplied in cartridges for SC injection with the Follistim Pen. Daily SC injections were started on Stimulation Day 1 and continued up to and including Stimulation Day 7.
From Stimulation Day 8 onwards a daily SC dose of 200 IU recFSH was administered up to and including the Day of hCG.
On Stimulation Day 5 a daily SC injection of 0.25 mg was started, which continued up to and including the day of hCG
When 3 follicles \>= 17 mm were observed by USS, a single dose of 10,000 IU/USP hCG was administered; or, for those at risk for Ovarian Hyperstimulation Syndrome (OHSS), a lower dose of 5,000 IU/USP
On the day of OPU, luteal phase support was started by administering micronized progesterone of at least 600 mg/day vaginally, or at least 50 mg/day intramuscular (IM), which continued for at least 6 weeks, or up to menses.
Percentage of Participants With an Ongoing Pregnancy (Cumulative Ongoing Pregnancy Rate)
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'.
Time frame: Up to 1 year after embryo transfer in base trial P05787 (NCT00696800), and FTET cycles in follow up trial
Percentage of Participants in Follow up Trial With a Miscarriage Per Clinical Pregnancy
Miscarriages were calculated per clinical pregnancy, meaning the presence of at least one gestational sac or confirmed by live birth.
Time frame: After one or more FTET cycles, up to day of miscarriage (up to 1 year)
Percentage of Participants in Follow up Trial With a Miscarriage Per Vital Pregnancy
Miscarriages were calculated per vital pregnancy, meaning the presence of at least one fetus with heart activity.
Time frame: After one or more FTET cycles, up to day of miscarriage (up to 1 year)
Percentage of Participants in Follow up Trial With an Ectopic Pregnancy
An ectopic pregnancy is where the embryo implants outside the uterus. Ectopic pregnancies were calculated per total number of participants started in FTET.
Time frame: After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)
Percentage of Participants in Follow up Trial With a Clinical Pregnancy
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.
Time frame: After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)
Percentage of Participants in Follow up Trial With a Vital Pregnancy
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.
Time frame: After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)
Percentage of Participants in Follow up Trial With an Ongoing Pregnancy
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.
Time frame: After one or more FTET, assessed at least 10 weeks after embryo transfer or at live birth (up to 1 year)
| Milestone | 150 µg Corifollitropin Alfa | 200 IU RecFSH |
|---|---|---|
| Started | 757 | 752 |
| Treated | 756 | 750 |
| Completed | 672 | 704 |
| Not completed | 85 | 48 |
| Milestone | 150 µg Corifollitropin Alfa | 200 IU RecFSH |
|---|---|---|
| Started | 168 | 176 |
| Completed | 148 | 147 |
| Not completed | 20 | 29 |
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'.
| Percentage of participants | 150 µg Corifollitropin Alfa | 200 IU RecFSH |
|---|---|---|
| Percentage of Participants With an Ongoing Pregnancy (Cumulative Ongoing Pregnancy Rate) | 47.2 | 44.9 |
Miscarriages were calculated per clinical pregnancy, meaning the presence of at least one gestational sac or confirmed by live birth.
| Percentage of participants | 150 µg Corifollitropin Alfa | 200 IU RecFSH |
|---|---|---|
| Percentage of Participants in Follow up Trial With a Miscarriage Per Clinical Pregnancy | 8.2 | 17.6 |
Miscarriages were calculated per vital pregnancy, meaning the presence of at least one fetus with heart activity.
| Percentage of participants | 150 µg Corifollitropin Alfa | 200 IU RecFSH |
|---|---|---|
| Percentage of Participants in Follow up Trial With a Miscarriage Per Vital Pregnancy | 0 | 0 |
An ectopic pregnancy is where the embryo implants outside the uterus. Ectopic pregnancies were calculated per total number of participants started in FTET.
| Percentage of participants | 150 µg Corifollitropin Alfa | 200 IU RecFSH |
|---|---|---|
| Percentage of Participants in Follow up Trial With an Ectopic Pregnancy | 1.2 | 0.6 |
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.
| Percentage of participants | 150 µg Corifollitropin Alfa | 200 IU RecFSH |
|---|---|---|
| Percentage of Participants in Follow up Trial With a Clinical Pregnancy | 43.5 | 38.6 |
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.
| Percentage of participants | 150 µg Corifollitropin Alfa | 200 IU RecFSH |
|---|---|---|
| Percentage of Participants in Follow up Trial With a Vital Pregnancy | 39.9 | 31.8 |
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.
| Percentage of participants | 150 µg Corifollitropin Alfa | 200 IU RecFSH |
|---|---|---|
| Percentage of Participants in Follow up Trial With an Ongoing Pregnancy | 38.7 | 30.7 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 150 µg Corifollitropin Alfa | — | 1/168 (0.6%) | 0/168 (0%) |
| 200 IU RecFSH | — | 0/176 (0%) | 0/176 (0%) |
| Event | 150 µg Corifollitropin Alfa | 200 IU RecFSH |
|---|---|---|
| Ectopic pregnancyPregnancy, puerperium and perinatal conditions | 1/168 | 0/176 |
Eligible participants from base study P05787 (NCT00696800) who enrolled in follow up study P05716
| Age, Continuous(Years) | 150 µg Corifollitropin Alfa | 200 IU RecFSH | Total |
|---|---|---|---|
| Mean | 31.1 ± 3.8 | 31.3 ± 3.0 | 31.2 ± 3.4 |
| Sex: Female, Male(Participants) | 150 µg Corifollitropin Alfa | 200 IU RecFSH | Total |
|---|---|---|---|
| Female | 168 | 176 | 344 |
| Male | 0 | 0 | 0 |
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