Pregnancy Clinical Trial
— CareOfficial title:
Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established After Ovulation Induction in Clinical Trial 107010 for the Development of Org 36286 (Corifollitropin Alfa)
Verified date | February 2022 |
Source | Organon and Co |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The objective of follow-up study P05713 is to evaluate whether corifollitropin alfa (Org 36286) treatment for the induction of monofollicular growth in women who underwent ovulation induction (OI) in base study P05693 (NCT00697255) is safe for pregnant participants and their offspring.
Status | Completed |
Enrollment | 1 |
Est. completion date | December 15, 2008 |
Est. primary completion date | August 9, 2008 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 39 Years |
Eligibility | Inclusion Criteria: - Participants who participated in base study P05693 (NCT00697255) and received at least one dose of corifollitropin alfa - Ongoing pregnancy confirmed by ultrasound at least 10 weeks after bolus injection of hCG in base study P05693 - Able and willing to give written informed consent (informed consent is incorporated in the informed consent form of protocol P05693) Exclusion Criteria: - None |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Organon and Co |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Mothers With =1 Live Born Infant During Follow-up (Take-Home Baby Rate): Protocol Defined | The Take-Home Baby Rate was defined as the number of participants with an ongoing pregnancy in base study P05693 (NCT00697255) with at least one live born infant in the current follow-up study divided by the total number of participants treated in base study P05693. | From =10 weeks after bolus injection of hCG (administered in study P05693) up to time of birth on current follow-up study (up to 1 year) | |
Primary | Percentage of Mothers With =1 Live Born Infant During Follow-up (Take-Home Baby Rate): Alternate Analysis | Take-Home Baby Rate was alternately defined ad hoc as the number of participants with an ongoing pregnancy in base study P05693 (NCT00697255) with at least one live born infant in the current follow-up study divided by the total number of participants who received bolus injection of hCG in the base study. | From =10 weeks after bolus injection of hCG (administered in study P05693) up to time of birth on current follow-up study (up to 1 year) | |
Primary | Number of Mothers With Adverse Events (AEs) During Follow-up | 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 =10 weeks after bolus injection of hCG (administered in study P05693) up to 1 day after birth on current follow-up study (up to 1 year) | |
Primary | Number of Mothers With Serious AEs (SAEs) During Follow-up | 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 =10 weeks after bolus injection of hCG (administered in study P05693) up to 1 day after birth on current follow-up study (up to 1 year) | |
Primary | Number of Infants With AEs During Follow-up | An AE is 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. | From =10 weeks after bolus injection of hCG (administered in study P05693) up to 12 weeks after birth on current follow-up study | |
Primary | Number of Infants With SAEs During Follow-up | An SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. | From =10 weeks after bolus injection of hCG (administered in study P05693) up to 12 weeks after birth on current follow-up study |
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