Follow-up Study of Frozen-thawed Embryo Transfer (FTET) Cycles After Cryopreservation of Embryos in Clinical Trial P05787 (P05716)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Follow-up Protocol to Collect the Outcome of Frozen-thawed Embryo Transfer Cycles After Cryopreservation of Embryos in Clinical Trial 38819

Conditions
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In Vitro Fertilization

Intervention / Treatment
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* Drug: 150 µg Corifollitropin Alfa
* Biological: 200 IU RecFSH/Follitropin beta (Days 1 to 7)
* Drug: Placebo for Corifollitropin Alfa
* Drug: Placebo for RecFSH/Follitropin beta
* Biological: 200 IU RecFSH/Follitropin beta (Days 8 to hCG)
* Drug: Ganirelix
* Biological: hCG
* Biological: Progesterone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants from whom embryos have been cryopreserved in Base Trial P05787 (NCT00696800), of which at least one embryo is thawed for use in a subsequent FTET cycle; Able and willing to give informed consent. Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 36 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 150 µg Corifollitropin Alfa<br>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<br>* 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.<br>Drug: Placebo for RecFSH/Follitropin beta<br>* 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.<br>Biological: 200 IU RecFSH/Follitropin beta (Days 8 to hCG)<br>* From Stimulation Day 8 onwards a daily SC dose of 200 IU recFSH was administered up to and including the Day of hCG.<br>Drug: Ganirelix<br>* On Stimulation Day 5 a daily SC injection of 0.25 mg was started, which continued up to and including the day of hCG<br>Biological: hCG<br>* 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<br>Biological: Progesterone<br>* 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.<br>|
| 200 IU RecFSH<br>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)<br>* Daily SC injections with 200 IU fixed dose recFSH were started on Stimulation Day 1 and continued up to and including Stimulation Day 7.<br>Drug: Placebo for Corifollitropin Alfa<br>* 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.<br>Biological: 200 IU RecFSH/Follitropin beta (Days 8 to hCG)<br>* From Stimulation Day 8 onwards a daily SC dose of 200 IU recFSH was administered up to and including the Day of hCG.<br>Drug: Ganirelix<br>* On Stimulation Day 5 a daily SC injection of 0.25 mg was started, which continued up to and including the day of hCG<br>Biological: hCG<br>* 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<br>Biological: Progesterone<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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'. | Up to 1 year after embryo transfer in base trial P05787 (NCT00696800), and FTET cycles in follow up trial | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | After one or more FTET, assessed at least 10 weeks after embryo transfer or at live birth (up to 1 year) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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In-vitro fertilization, Controlled Ovarian Stimulation, Cumulative pregnancy data, Follow-up