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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-003812-23 | EudraCT Number | ||
| 107014 | Other Identifier | Organon | |
| MK-8962-003 | Other Identifier | Merck |
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The objective of this follow-up study is to evaluate whether corifollitropin alfa (Org 36286) treatment for the induction of multifollicular growth in women undergoing controlled ovarian stimulation (COS) prior to in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) is safe for pregnant participants and their offspring.
This is a follow-up protocol to prospectively monitor pregnancy, delivery, and neonatal outcome of women who were treated with corifollitropin alfa or recFSH and became pregnant during the base study P05690 (NCT00702845). For this trial no study specific assessments are required, but information as obtained in standard practice will be used.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Corifollitropin alfa 100 μg | In follow-up study, no medication or investigational product was administered. In base study P05690 (NCT00702845), participants 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 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 Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day by intramuscular [IM] injection), starting on day of oocyte pick-up (OPU) and continuing for at least 6 weeks or up to menses. |
| |
| recFSH 150 IU | In follow-up study, no medication or investigational product was administered. 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 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Women With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate) | The Take-Home Baby Rate was defined as the number of participants with an ongoing pregnancy in base study P05690 with at least one live born infant during follow up relative to the number of participants treated in base study. | From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months) |
| Number of Expectant Mothers Experiencing Adverse Events (AEs) | An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. | From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months) |
| Number of Expectant Mothers Experiencing Serious AEs (SAEs) | An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect. | From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months) |
| Number of Infants Experiencing AEs | An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. |
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Inclusion Criteria:
Exclusion Criteria:
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Women with an ongoing pregnancy at least 10 weeks after embryo transfer in base study P05690 (NCT00702845) were enrolled in this trial.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22587997 | Derived | Bonduelle M, Mannaerts B, Leader A, Bergh C, Passier D, Devroey P. Prospective follow-up of 838 fetuses conceived after ovarian stimulation with corifollitropin alfa: comparative and overall neonatal outcome. Hum Reprod. 2012 Jul;27(7):2177-85. doi: 10.1093/humrep/des156. Epub 2012 May 15. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Corifollitropin Alfa 100 μg Women/Expectant Mothers | 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 by intramuscular [IM] injection), 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 P05710, but no study treatments were given. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Base Study P05690 (NCT00702845) |
|
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| recFSH (follitropin beta) | Biological | Daily recFSH administered under protocol P05690 |
|
|
| gonadatropin releasing hormone (GnRH) antagonist ganirelix | Drug | GnRH antagonist ganirelix administered SC at a dose of 0.25 mg/day under protocol P05690 |
|
| human chorion gonadotropin (hCG) | Biological | hCG 5,000 IU/USP or 10,000 IU/USP administered under protocol P05690 |
|
| 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. |
|
| placebo-recFSH (follitropin beta) | Drug | Placebo-recFSH at the equivalent volume of 150 IU/day administered under protocol P05690 |
|
| placebo-corifollitropin alfa | Drug | Single SC injection of placebo-corifollitropin alfa on Day 2 or 3 of the menstrual cycle, administered under protocol P05690 |
|
| open-label recFSH (follitropin beta) | Biological | Open-label recFSH up to a maximum dose of 200 IU/day, administered under protocol P05690 |
|
| Up to 12 weeks after birth |
| Number of Infants Experiencing SAEs | An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect. | Up to 12 weeks after birth |
| FG001 | recFSH 150 IU Women/Expectant Mothers | 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 P05710, but no study treatments were given. |
| FG002 | Corifollitropin Alfa 100 μg Fetuses at 10 Weeks After ET | This group includes fetuses of expectant mothers who were administered corifollitropin alfa in base study P05690 (NCT00702845). The fetuses were present at 10 weeks after embryo transfer (ET) in the base study, and expectant mothers were eligible for enrollment in follow up study P05710. |
| FG003 | recFSH 150 IU Fetuses at 10 Weeks After ET | This group includes fetuses of expectant mothers who were administered recFSH on base study P05690 (NCT00702845). The fetuses were present at 10 weeks after ET in the base study, and expectant mothers were eligible for enrollment in follow up study P05710. |
| COMPLETED |
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| NOT COMPLETED |
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| Expectant Mother Follow-up |
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| Fetuses/Infant Follow-up |
|
Individuals who participated in base study P05690 (NCT00702845) and received at least one dose of either corifollitropin alfa or recFSH, who had an ongoing pregnancy confirmed by ultrasound at least 10 weeks after ET in base study P05690 and were able and willing to give written informed consent.
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| ID | Title | Description |
|---|---|---|
| BG000 | Corifollitropin Alfa 100 μg Expectant Mothers | 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 P05710, but no study treatments were given. |
| BG001 | recFSH 150 IU Expectant Mothers | 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 P05710, but no study treatments were given. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| 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 |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 Women With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate) | The Take-Home Baby Rate was defined as the number of participants with an ongoing pregnancy in base study P05690 with at least one live born infant during follow up relative to the number of participants treated in base study. | 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 | From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months) |
|
|
| |||||||||||||||||||||||||||||
| Primary | Number of Expectant Mothers Experiencing Adverse Events (AEs) | An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. | Follow-up safety analysis was performed on expectant mothers who received corifollitropin alfa or recFSH on base study P05690 (NCT00702845) and who enrolled on the follow-up study. | Posted | Number | Participants | From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months) |
| |||||||||||||||||||||||||||||||
| Primary | Number of Expectant Mothers Experiencing Serious AEs (SAEs) | An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect. | Follow-up safety analysis was performed on expectant mothers who received corifollitropin alfa or recFSH on base study P05690 (NCT00702845) and who enrolled on the follow-up study. | Posted | Number | Participants | From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months) |
| |||||||||||||||||||||||||||||||
| Primary | Number of Infants Experiencing AEs | An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. | Follow-up safety analysis was performed on live born infants delivered by expectant mothers who received corifollitropin alfa or recFSH on base study P05690 (NCT00702845) and who enrolled on the follow-up study. | Posted | Number | Live born infants | Up to 12 weeks after birth |
| |||||||||||||||||||||||||||||||
| Primary | Number of Infants Experiencing SAEs | An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect. | Follow-up safety analysis was performed on live born infants delivered by expectant mothers who received corifollitropin alfa or recFSH on base study P05690 (NCT00702845) and who enrolled on the follow-up study. | Posted | Number | Live born infants | Up to 12 weeks after birth |
|
|
From approximately 10 weeks after ET in base study P05690 (NCT00702845) up to 12 weeks after birth in current follow-up study (up to approximately 9 months)
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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 Expectant Mothers | 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 by intramuscular [IM] injection), 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 P05710, but no study treatments were given. | 38 | 68 | 13 | 68 | ||
| EG001 | recFSH 150 IU Expectant Mothers | 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 P05710, but no study treatments were given. | 21 | 45 | 17 | 45 | ||
| EG002 | Corifollitropin Alfa 100 μg Fetuses at 10 Weeks After ET | This group includes fetuses of expectant mothers who were administered corifollitropin alfa in base study P05690 (NCT00702845). The fetuses were present at 10 weeks after embryo transfer (ET) in the base study, and expectant mothers were eligible for enrollment in follow up study P05710. | 31 | 88 | 9 | 88 | ||
| EG003 | recFSH 150 IU Fetuses at 10 Weeks After ET | This group includes fetuses of expectant mothers who were administered recFSH on base study P05690 (NCT00702845). The fetuses were present at 10 weeks after ET in the base study, and expectant mothers were eligible for enrollment in follow up study P05710. | 16 | 55 | 5 | 55 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mitral valve prolapse | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
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| Bradycardia foetal | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
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| Tachycardia foetal | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
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| Liver disorder | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Intrauterine infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Transfusion-related acute lung injury | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Abortion missed | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
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| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
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| Antepartum haemorrhage | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Arrested labour | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Breech presentation | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Cephalo-pelvic disproportion | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Cervical incompetence | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Cervix dystocia | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
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| Chorioamnionitis | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Complication of delivery | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Failed induction of labour | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Foetal distress syndrome | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Foetal hypokinesia | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Foetal macrosomia | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
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| Foetal malposition | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
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| Foetal malpresentation | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Intra-uterine death | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
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| Multiple pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
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| Oligohydramnios | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
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| Placenta praevia | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
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| Pre-eclampsia | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
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| Pregnancy induced hypertension | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
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| Premature labour | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
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| Premature rupture of membranes | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
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| Premature separation of placenta | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
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| Prolonged labour | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
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| Stillbirth | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
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| Threatened labour | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
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| Twin pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
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| Uterine contractions during pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
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| Uterine hypotonus | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
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| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Cervix cerclage procedure | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
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| Thrombocytopenia neonatal | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
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| Pulmonary valve stenosis | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
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| Aplasia cutis congenita | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
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| Atrial septal defect | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
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| Congenital infection | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
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| Congenital pneumonia | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
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| Congenital pulmonary artery anomaly | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
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| Congenital pyelocaliectasis | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
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| Congenital syphilis | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Haemangioma congenital | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
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| Patent ductus arteriosus | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
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| Pulmonary artery stenosis congenital | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
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| Pyloric stenosis | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
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| Renal dysplasia | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
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| Ventricular septal defect | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
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| Retinopathy of prematurity | Eye disorders | MedDRA 12.0 | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Fever neonatal | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Oedema neonatal | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Hyperbilirubinaemia neonatal | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
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| Neonatal cholestasis | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
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| Oral fungal infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Pneumonia chlamydial | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Pneumonia viral | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Pulmonary sepsis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Sepsis neonatal | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Staphylococcal infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Cardiac murmur functional | Investigations | MedDRA 12.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
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| Hypoglycaemia neonatal | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
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| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
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| Metabolic alkalosis | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
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| Neonatal hyponatraemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cerebral infarction foetal | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Intraventricular haemorrhage neonatal | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypothermia neonatal | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
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| Jaundice neonatal | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
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| Premature baby | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Small for dates baby | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Nephrocalcinosis | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pyelocaliectasis | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Bronchopulmonary dysplasia | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypoventilation neonatal | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Infantile apnoeic attack | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Neonatal respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pulmonary hypertensive crisis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Respiratory disorder neonatal | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Transient tachypnoea of the newborn | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Neonatal hypotension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hydrops foetalis | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Abnormal labour | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Antepartum haemorrhage | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Placenta praevia | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Threatened labour | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hyperbilirubinaemia neonatal | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Jaundice neonatal | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
|
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 |
|---|---|
| D000013 | Congenital Abnormalities |
| ID | Term |
|---|---|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
Not provided
Not provided
| ID | Term |
|---|---|
| C437186 | follicle stimulating hormone, human, with HCG C-terminal peptide |
| C571802 | follitropin beta |
| 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 |
Not provided
Not provided
| Male |
|
| OG001 | recFSH 150 IU Expectant Mothers | 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 P05710, but no study treatments were given. |
|
|
| recFSH 150 IU Expectant Mothers |
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 P05710, but no study treatments were given. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Participants |
|
|