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| ID | Type | Description | Link |
|---|---|---|---|
| 38834 | Other Identifier | Organon | |
| MK-8962-010 | Other Identifier | Merck | |
| 2005-000062-40 | EudraCT Number |
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The objective of this trial is to evaluate whether corifollitropin alfa (MK-8962, 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 outcomes of all women who were treated with corifollitropin alfa and became pregnant during the base Trial 38833. For this follow-up trial (38834), no investigational products will be administered and no study specific assessments are required, but information will be obtained as per standard clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Corifollitropin alpha 100 ug | In the base study (P05788, 38833, NCT00702351), participants were pre-treated with daily subcutaneous (SC) injections of 0.1 mg triptorelin started between Day 21 and 24 of the menstrual cycle (mid luteal phase). After suppression of endogenous luteinizing hormone (LH) and follicle stimulating hormone (FSH) was confirmed by estradiol (E2) and progesterone (P) measurements, a single dose of corifollitropin alpha 100 μg was administered in participants weighing <= 60 kg. From stimulation Day 8 onwards, treatment was continued with daily SC of recombinant follicle stimulating hormone (recFSH) injections (maximally 200 IU) up to and including the day of administration of human chorionic gonadotprophin (hCG). No study medications were administered in the present P05783 study (38834, NCT00702520). |
| |
| Corifollitropin alpha 150 ug | In the base study (P05788, 38833, NCT00702351), participants were pre-treated with daily SC injections of 0.1 mg triptorelin started between Day 21 and 24 of the menstrual cycle (mid luteal phase). After suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 150 μg was administered in participants weighing >= 50 kg. From stimulation Day 8 onwards, treatment was continued with daily SC of recFSH injections (maximally 200 IU) up to and including the day of administration of hCG. No study medications were administered in the present P05783 study (38834, NCT00702520). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corifollitropin alpha (MK-8962, Org 36286) 100 ug | Drug | Subcutaneous administration of corifollitropin alpha at a dose of 100 ug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Expectant Mothers Experiencing Adverse Events (AEs) | An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the study drug. | Up to 1 Year |
| Number of Expectant Mothers Experiencing Serious AEs (SAEs) | An AE or suspected adverse reaction is considered "serious" if, in the view of either the investigator or sponsor, it results in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. | Up to 1 Year |
| Number of Infants Experiencing AEs | An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the study drug. | Up to 1 Year |
| Number of Infants Experiencing SAEs | An AE or suspected adverse reaction is considered "serious" if, in the view of either the investigator or sponsor, it results in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. |
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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 Trial 38833 were enrolled in this trial.
| 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 | Expectant Mothers Administered Corifollitropin Alpha 100 ug | In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 100 μg was administered in participants weighing <= 60 kg. No study medications were administered in the follow-up P05783 study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Base Study P05788 - Assigned Treatment |
|
Not provided
Not provided
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| Corifollitropin alpha (MK-8962, Org 36286) 150 ug | Drug | Subcutaneous administration of corifollitropin alpha at a dose of 150 ug |
|
| Triptorelin | Drug | Daily SC injections of 0.1 mg triptorelin started between Day 21 and 24 of the menstrual cycle (mid luteal phase). |
|
| Recombinant follicle stimulating hormone (recFSH) | Biological | From stimulation Day 8 onwards, treatment was continued with daily SC of recFSH injections (maximally 200 IU) up to and including the day of administration of hCG. |
|
| Human chorionic gonadotprophin (hCG). | Biological | HCG was administered as a single subcutaneous injection of 5,000 to 10,000 international units. |
|
| Up to 1 Year |
| Take-Home Baby Rate | The take-home baby rate was calculated as the number of participants with a least one live born infant in the follow-up study (P05783, 38834, NCT00702520) relative to the number of participants treated with Corifollitropin alpha in the base study (P05788, 38833, NCT00702351). | Birth of a one or more live babies (Up to 1 year) |
| FG001 |
| Expectant Mothers Administered Corifollitropin Alpha 150 ug |
In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 150 μg was administered in participants weighing >= 50 kg. No study medications were administered in the follow-up P05783 study. |
| FG002 | Infants From Mothers Administered Corifollitropin Alpha 100 ug | Infants born to mothers who received 100 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520). No study medications were administered in the follow-up P05783 study. |
| FG003 | Infants From Mothers Administered Cori. Alpha 150 ug | Infants from mothers who received 150 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520). No study medications were administered in the follow-up P05783 study. |
| Treated With Corifollitropin Alpha |
|
| Treated With hCG and Had Oocyte Pick-up |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Base Study P05788 - Embryo Transfer |
|
|
| Base Study P05788 - Follow-Up |
|
|
| Follow-up Study P05783 |
|
The overall number of baseline participants reflects the number of participants that started the P05783 follow-up study and not the number of participants in the P05788 base study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Expectant Mothers Administered Corifollitropin Alpha 100 ug | In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 100 μg was administered in participants weighing <= 60 kg. No study medications were administered in the follow-up P05783 study. |
| BG001 | Expectant Mothers Administered Corifollitropin Alpha 150 ug | In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 150 μg was administered in participants weighing >= 50 kg. No study medications were administered in the follow-up P05783 study. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Number of Expectant Mothers Experiencing Adverse Events (AEs) | An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the study drug. | Follow-up safety analysis was performed on expectant mothers who received corifollitropin alfa in the base study P05690 (NCT00702845) and who enrolled in the follow-up study (P05783, 38834, NCT00702520). | Posted | Number | Participants | Up to 1 Year |
|
|
| |||||||||||||||||||||||||||||
| Primary | Number of Expectant Mothers Experiencing Serious AEs (SAEs) | An AE or suspected adverse reaction is considered "serious" if, in the view of either the investigator or sponsor, it results in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. | Follow-up safety analysis was performed on expectant mothers who received corifollitropin alfa in the base study P05690 (NCT00702845) and who enrolled in the follow-up study (P05783, 38834, NCT00702520). | Posted | Number | Participants | Up to 1 Year |
| |||||||||||||||||||||||||||||||
| Primary | Number of Infants Experiencing AEs | An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the study drug. | Follow-up safety analysis was performed on live born infants delivered by expectant mothers who received corifollitropin alfa in the base study P05690 (NCT00702845) and who enrolled in the follow-up study (P05783, 38834, NCT00702520). | Posted | Number | Participants | Up to 1 Year |
| |||||||||||||||||||||||||||||||
| Primary | Number of Infants Experiencing SAEs | An AE or suspected adverse reaction is considered "serious" if, in the view of either the investigator or sponsor, it results in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. | Follow-up safety analysis was performed on live born infants delivered by expectant mothers who received corifollitropin alfa in the base study P05690 (NCT00702845) and who enrolled in the follow-up study (P05783, 38834, NCT00702520). | Posted | Number | Participants | Up to 1 Year |
| |||||||||||||||||||||||||||||||
| Primary | Take-Home Baby Rate | The take-home baby rate was calculated as the number of participants with a least one live born infant in the follow-up study (P05783, 38834, NCT00702520) relative to the number of participants treated with Corifollitropin alpha in the base study (P05788, 38833, NCT00702351). | Participants treated with Corifollitropin alpha in the base study (P05788, 38833). | Posted | Number | Percentage of participants | Birth of a one or more live babies (Up to 1 year) |
|
Up to 1 year
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Expectant Mothers Administered Corifollitropin Alpha 100 ug | In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 100 μg was administered in participants weighing <= 60 kg. No study medications were administered in the P05783 study (38834, NCT00702520). | 2 | 7 | 7 | 7 | ||
| EG001 | Expectant Mothers Administered Corifollitropin Alpha 150 ug | In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 150 μg was administered in participants weighing >= 50 kg. No study medications were administered in the follow-up P05783 study. | 2 | 8 | 6 | 8 | ||
| EG002 | Fetuses/Infants From Mothers Administered Cori. Alpha 100 ug | Fetuses/Infants from mothers who received 100 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520) according to standard practice. No study medications were administered in the follow-up P05783 study. | 6 | 8 | 5 | 8 | ||
| EG003 | Fetuses/Infants From Mothers Administered Cori. Alpha 150 ug | Fetuses/Infants from mothers who received 150 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520) according to standard practice. No study medications were administered in the follow-up P05783 study. | 7 | 11 | 11 | 11 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Accessory auricle | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Atrial septal defect | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Congenital choroid plexus cyst | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Congenital labia pudendi adhesions | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Congenital laryngeal stridor | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Congenital naevus | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pilonidal cyst congenital | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pulmonary valve stenosis congenital | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Scaphocephaly | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Skull malformation | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cholestasis of pregnancy | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Blood pressure decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Torticollis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Breech presentation | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Placenta praevia | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Premature baby | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Premature labour | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Small for dates baby | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Threatened labour | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Apparent life threatening event | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Intercostal retraction | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Neonatal anoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Neonatal respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hair growth abnormal | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Patent ductus arteriosus | Congenital, familial and genetic disorders | 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 |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Craniotabes | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Gastric disorder | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Regurgitation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Fever neonatal | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Suprapubic pain | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Acute tonsillitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Candidiasis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Enteritis infectious | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Vaccination complication | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Streptococcal identification test positive | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Antepartum haemorrhage | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Breech presentation | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Foetal distress syndrome | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Intrapartum haemorrhage | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Meconium in amniotic fluid | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Perineal laceration | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Placenta praevia haemorrhage | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Postpartum haemorrhage | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Premature rupture of membranes | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Premature separation of placenta | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Uterine contractions during pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast 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 |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cervix cerclage procedure | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
| |
| Uterine dilation and curettage | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Varicose vein | Vascular disorders | 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 the 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 |
| D017329 | Triptorelin Pamoate |
| D015292 | Glycoprotein Hormones, alpha Subunit |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| 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 |
| D006063 | Chorionic Gonadotropin |
| D006062 | Gonadotropins |
| D005640 | Follicle Stimulating Hormone |
| D006065 | Gonadotropins, Pituitary |
| D007986 | Luteinizing Hormone |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D013972 | Thyrotropin |
| D010926 | Placental Hormones |
Not provided
Not provided
| Male |
|
In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 150 μg was administered in participants weighing >= 50 kg. No study medications were administered in the follow-up P05783 study.
|
|
| Units | Counts |
|---|
| Participants |
|
|
Infants from mothers who received 150 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520). No study medications were administered in the follow-up P05783 study.
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|