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| ID | Type | Description | Link |
|---|---|---|---|
| 2004-004773-28 | EudraCT Number | ||
| 38831 | Other Identifier | Organon | |
| MK-8962-009 | Other Identifier | Merck |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 150 µg Corifollitropin Alfa | 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 150 µg Corifollitropin Alfa | Drug | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Women from whom embryos have been cryopreserved in Base Trial P05787 (NCT00696800).
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22459628 | Derived | Boostanfar R, Mannaerts B, Pang S, Fernandez-Sanchez M, Witjes H, Devroey P; Engage Investigators. A comparison of live birth rates and cumulative ongoing pregnancy rates between Europe and North America after ovarian stimulation with corifollitropin alfa or recombinant follicle-stimulating hormone. Fertil Steril. 2012 Jun;97(6):1351-8. doi: 10.1016/j.fertnstert.2012.02.038. Epub 2012 Mar 28. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Base Study P05787 (NCT00696800) |
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| 200 IU RecFSH/Follitropin beta (Days 1 to 7) | Biological | Daily SC injections with 200 IU fixed dose recFSH were started on Stimulation Day 1 and continued up to and including Stimulation Day 7. |
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| Placebo for Corifollitropin Alfa | Drug | 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. |
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| Placebo for RecFSH/Follitropin beta | Drug | 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. |
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| 200 IU RecFSH/Follitropin beta (Days 8 to hCG) | Biological | From Stimulation Day 8 onwards a daily SC dose of 200 IU recFSH was administered up to and including the Day of hCG. |
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| Ganirelix | Drug | On Stimulation Day 5 a daily SC injection of 0.25 mg was started, which continued up to and including the day of hCG |
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| hCG | Biological | 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 |
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| Progesterone | Biological | 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. |
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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) |
| FG001 | 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. |
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| COMPLETED |
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| NOT COMPLETED |
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| Follow Up Study P05716 (NCT00702273) |
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Eligible participants from base study P05787 (NCT00696800) who enrolled in follow up study P05716
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 FTET cycles. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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'. | ITT group from base trial P05787, consisting of randomized participants who were treated with Corifollitropin Alfa or recFSH. | Posted | Number | Percentage of participants | Up to 1 year after embryo transfer in base trial P05787 (NCT00696800), and FTET cycles in follow up trial |
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| Secondary | 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. | Participants enrolled in P05716 Follow Up study that had a clinical pregnancy. | Posted | Number | Percentage of participants | After one or more FTET cycles, up to day of miscarriage (up to 1 year) |
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| Secondary | 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. | Participants enrolled in P05716 Follow Up study that had a vital pregnancy. | Posted | Number | Percentage of participants | After one or more FTET cycles, up to day of miscarriage (up to 1 year) |
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| Secondary | 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. | Participants enrolled in P05716 Follow Up study. | Posted | Number | Percentage of participants | After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year) |
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| Secondary | 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. | Participants enrolled in P05716 Follow Up study, that had an embryo transfer in the respective cycle. | Posted | Number | Percentage of participants | After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year) |
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| Secondary | 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. | Participants enrolled in P05716 Follow Up study, that had an embryo transfer in the respective cycle. | Posted | Number | Percentage of participants | After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year) |
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| Secondary | 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. | Participants enrolled in P05716 Follow Up study, that had an embryo transfer in the respective cycle. | Posted | Number | Percentage of participants | After one or more FTET, assessed at least 10 weeks after embryo transfer or at live birth (up to 1 year) |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 FTET cycles. | 1 | 168 | 0 | 168 | ||
| EG001 | 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. | 0 | 176 | 0 | 176 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Non-systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| C437186 | follicle stimulating hormone, human, with HCG C-terminal peptide |
| C571802 | follitropin beta |
| C061018 | ganirelix |
| D011374 | Progesterone |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003339 | Corpus Luteum Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045167 | Progesterone Congeners |
| D012739 | Gonadal Steroid Hormones |
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