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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-003813-42 | EudraCT Number | ||
| 107015 | Other Identifier | Organon | |
| MK-8962-004 | Other Identifier | Merck |
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Clinical trial objective is to collect the outcome of Frozen-Thawed Embryo Transfer (FTET) cycles performed after the embryos are cryopreserved in the base study P05690 in order to estimate the cumulative pregnancy rate for each treatment group.
This is a follow-up protocol to collect the outcome of FTET cycles, performed after the embryos are cryopreserved in base study P05690 (NCT00702845), to enable estimation of the cumulative pregnancy rate for each treatment group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Corifollitropin alfa 100 μg | In follow-up study, no medication or investigational product was administered. But in base study P05690 (NCT00702845), participants received single subcutaneous (SC) injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of the menstrual cycle and daily placebo-recombinant Follicle Stimulating Hormone (recFSH) injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants in base study P05690 also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of Human Chorion Gonadotropin (hCG) administration. Participants also received Gonadotropin Releasing Hormone (GnRH) antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of oocyte pick-up (OPU) and continuing for at least 6 weeks or up to menses. |
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| recFSH 150 IU | In this follow-up study, no medication or investigational product was administered. However, in base study P05690 (NCT00702845), participants in the reference group received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the day of hCG (10,000 or 5,000 IU/USP) administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG. Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the day of OPU and continuing for at least 6 weeks or up to menses. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| corifollitropin alfa | Drug | Single injection of 100 μg corifollitropin alfa administered under protocol P05690 |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With an Ongoing Pregnancy (Cumulative Ongoing Pregnancy Rate) | Cumulative ongoing pregnancy rate was defined as 100 times the number of participants with an ongoing pregnancy either immediately after embryo transfer in base study P05690 (NCT00702845) or after one or more FTET cycles in follow up study P05711 following cryopreservation, divided by the total number of subjects that started treatment in base study P05690. | Up to 1 year after embryo transfer in base trial P05690 (NCT00702845), and FTET cycles in follow up study P05711 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants in Follow up Study With a Miscarriage Per Clinical Pregnancy | Miscarriages were calculated per clinical pregnancy, defined as the presence of at least one gestational sac as assessed by USS or Doppler, or confirmed by live birth. | After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year) |
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Inclusion Criteria:
Exclusion Criteria:
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Women from whom embryos have been cryopreserved in base study P05690
Period one consists of participants from the base study P05690 (NCT00702845) randomized to treatment groups corifollitropin alfa (Org 36286) or recombinant Follicle Stimulating Hormone (recFSH). Period two consists of eligible participants (N = 102) from the base study who enrolled in the follow up study P05711.
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| ID | Title | Description |
|---|---|---|
| FG000 | Corifollitropin Alfa 100 μg | Participants in base study P05690 received single subcutaneous (SC) injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recombinant Follicle Stimulating Hormone (recFSH) injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of Human Chorion Gonadotropin (hCG) administration. Participants also received Gonadotropin Releasing Hormone (GnRH) antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of oocyte pick-up (OPU) and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in base study underwent FTET cycles. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Base Study P05690 (NCT00702845) |
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| recFSH (follitropin alfa) | Biological | Daily recFSH administered under protocol P05690 |
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| gonadatropin releasing hormone (GnRH) antagonist ganirelix | Drug | GnRH antagonist ganirelix administered SC at a dose of 0.25 mg/day under protocol P05690 |
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| human chorion gonadatropin (hCG) | Drug | hCG 5,000 IU or 10,000 IU administered SC under protocol P05690 |
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| progesterone | Biological | Under protocol P05690, progesterone was started on the day of oocyte pick-up (OPU) and continued for at least 6 weeks or up to menses. Participants received at least 600 mg/day vaginally or 50 mg/day IM. |
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| placebo-recFSH (follitropin alfa) | Drug | Placebo-recFSH at the equivalent volume of 150 IU/day administered under protocol P05690 |
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| placebo-corifollitropin alfa | Drug | Single SC injection of placebo-corifollitropin alfa on Day 2 or 3 of the menstrual cycle, administered under protocol P05690 |
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| open-label recFSH | Biological | Open-label recFSH up to a maximum dose of 200 IU/day, administered under protocol P0590 |
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| Percentage of Participants in Follow up Study With a Miscarriage Per Vital Pregnancy | Miscarriages were calculated per vital pregnancy, defined as the presence of at least one fetus with heart activity as assessed by USS or Doppler, or confirmed by live birth. | After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year) |
| Percentage of Participants in Follow up Study With an Ecotopic 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 Study 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 Study 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 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 | recFSH 150 IU | Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in the base study underwent FTET cycles. |
| COMPLETED |
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| NOT COMPLETED |
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| Follow Up Study P05711 (NCT00702546) |
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Eligible participants from base study P05690 (NCT00702845) who enrolled in follow up study P05711
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| ID | Title | Description |
|---|---|---|
| BG000 | Corifollitropin Alfa 100 μg | Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on Day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in base study underwent FTET cycles. |
| BG001 | recFSH 150 IU | Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05711, but 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 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Cumulative ongoing pregnancy rate was defined as 100 times the number of participants with an ongoing pregnancy either immediately after embryo transfer in base study P05690 (NCT00702845) or after one or more FTET cycles in follow up study P05711 following cryopreservation, divided by the total number of subjects that started treatment in base study P05690. | Intent-to-Treat (ITT) group from base study P05690 (NCT00702845), which consisted 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 P05690 (NCT00702845), and FTET cycles in follow up study P05711 |
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| Secondary | Percentage of Participants in Follow up Study With a Miscarriage Per Clinical Pregnancy | Miscarriages were calculated per clinical pregnancy, defined as the presence of at least one gestational sac as assessed by USS or Doppler, or confirmed by live birth. | Participants in follow up study P05711 with a clinical pregnancy | 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 Study With a Miscarriage Per Vital Pregnancy | Miscarriages were calculated per vital pregnancy, defined as the presence of at least one fetus with heart activity as assessed by USS or Doppler, or confirmed by live birth. | Participants enrolled in follow up study P05711 with vital pregnancy | 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 Study With an Ecotopic 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 follow up study P05711 | 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 Study 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 follow up study P05711 | 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 Study 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 follow up study P05711 | 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 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 follow up study P05711 | 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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In Follow Up Study P05711, Serious Adverse Events (AEs) were not systematically monitored. Instead, any reported Serious AEs were unsolicited and non-systematically assessed. Other Adverse Events were not monitored and not collected.
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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 | Corifollitropin Alfa 100 μg | Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo-recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on Day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in base study underwent FTET cycles. | 1 | 77 | 0 | 0 | ||
| EG001 | recFSH 150 IU | Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in the base study underwent FTET cycles. | 0 | 25 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cytogenetic abnormality | Congenital, familial and genetic disorders | MedDRA 11.1 | Non-systematic Assessment |
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The Sponsor recognizes the right of the investigator(s) to publish, but all publications must be based on data validated and released by the Sponsor. Any such scientific paper, presentation, or other communication concerning the clinical trial described in this protocol will first be submitted to Sponsor, at least six weeks ahead of estimated publication or presentation, for written consent, which shall not be withheld unreasonably.
| 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 |
| C571801 | follitropin alfa |
| D007987 | Gonadotropin-Releasing Hormone |
| D011374 | Progesterone |
| ID | Term |
|---|---|
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003339 | Corpus Luteum Hormones |
| D042341 | Gonadal Hormones |
| D045167 | Progesterone Congeners |
| D012739 | Gonadal Steroid Hormones |
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Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05711, but no study treatments were given, and embryos obtained in the base study underwent FTET cycles.
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