Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05693 (P05713)

Study Overview
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Brief Summary
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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.

Detailed Description
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Base study P05693 (NCT00697255) was planned to include two separate stages (Ia+Ib and II). Stage Ia was open-label and uncontrolled in a small cohort of women (n=5) to explore whether the intended dosing regimen of corifollitropin alfa followed by daily low dose recombinant Follicle Stimulating Hormone (recFSH) would provide an appropriate response in eligible participants meeting all inclusion and none of the exclusion criteria. Stage Ib was open-label and uncontrolled in a small cohort of women (n=3) to explore whether the intended dosing regimen of corifollitropin alfa followed by daily low dose Human Chorion Gonadotropin (hCG) would provide an appropriate response in eligible participants meeting all inclusion and none of the exclusion criteria. Stage II was planned to be open-label and randomized (n=40) to evaluate whether the intended dosing regimen of corifollitropin alfa followed by low dose recFSH (n=20) or hCG (n=20) would provide an appropriate response in eligible participants meeting all inclusion and none of the exclusion criteria. P05713 is a follow-up (FU) study to prospectively monitor pregnancy, delivery, and neonatal outcome of women who became ongoing pregnant during base study P05693 (NCT00697255). For this trial, no study specific assessments will be required and no treatment will be administered, but information as obtained in standard practice will be used. Enrollment will begin when the first ongoing pregnancy resulting from the base study has been established (ultrasound ≥ 10 weeks after bolus injection of hCG).

Official Title
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Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established After Ovulation Induction in Clinical Trial 107010 for the Development of Org 36286 (Corifollitropin Alfa)

Conditions
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Pregnancy, Neonates

Intervention / Treatment
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* Drug: corifollitropin alfa
* Biological: recombinant Follicle Stimulating Hormone (recFSH)
* Biological: human Chorion Gonadotropin (hCG)
* Biological: hCG Bolus injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| corifollitropin alfa + recFSH Mothers<br>Eligible participants in Stage 1a of base study P05693 (NCT00697255) were administered injection(s) with subcutaneous (SC) corifollitropin alfa (15mcg) and daily SC injections with recFSH (50 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then to be followed for safety and efficacy on the current follow-up (FU) study (P05713) according to standard practice (no treatment administered). | Drug: corifollitropin alfa<br>* SC injection(s) of corifollitropin alfa (30 mcg) was administered the first, second or third day after onset of progestagen-induced withdrawal bleeding in base study P05693 (NCT00697255). No treatment was administered on the current follow-up study.<br>* Other names: SCH 900962;Biological: recombinant Follicle Stimulating Hormone (recFSH)<br>* Daily injections of SC recFSH (50 IU/75 IU) were administered as soon as the largest follicle reached a size ≥ 12 mm 4 days after a corifollitropin alfa injection (on stimulation day 5, 9 or 13) in base study P05693 (NCT00697255). No treatment was administered on the current follow-up study.<br>Biological: hCG Bolus injection<br>* Bolus injection of SC hCG was administered in base study P05693 (NCT00697255) to induce final oocyte maturation if at least one follicle was ≥18 mm and no more than two follicles ≥15 mm were observed. No treatment was administered on the current follow-up study.<br>|
| corifollitropin alfa + hCG Mothers<br>Eligible participants in Stage 1b of base study P05693 (NCT00697255) were administered injection(s) with SC corifollitropin alfa (30 mcg) and daily SC injections with hCG (200 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then followed for safety and efficacy on the current FU study (P05713) according to standard practice (no treatment administered). | Drug: corifollitropin alfa<br>* SC injection(s) of corifollitropin alfa (30 mcg) was administered the first, second or third day after onset of progestagen-induced withdrawal bleeding in base study P05693 (NCT00697255). No treatment was administered on the current follow-up study.<br>* Other names: SCH 900962;Biological: human Chorion Gonadotropin (hCG)<br>* Daily injections of SC hCG injection were administered as soon as the largest follicle reached a size ≥ 12 mm 4 days after a corifollitropin alfa injection (on stimulation day 5, 9 or 13) in base study P05693 (NCT00697255). No treatment was administered on the current follow-up study.<br>Biological: hCG Bolus injection<br>* Bolus injection of SC hCG was administered in base study P05693 (NCT00697255) to induce final oocyte maturation if at least one follicle was ≥18 mm and no more than two follicles ≥15 mm were observed. No treatment was administered on the current follow-up study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neonatal outcome, Congenital malformations, Ovulation Induction, Follow-up