Clinical trial NCT00702338: Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05693 (P05713)
Official 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Neonates
Keywords: Neonatal outcome
Congenital malformations
Ovulation Induction
Follow-up
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-06-20
Enrollment: 1
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with an ongoing pregnancy at least 10 weeks after bolus injection of hCG in base study P05693 (NCT00697255).

Brief summary: 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: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Mothers With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate): Protocol Defined
timeFrame: 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)
measure: Percentage of Mothers With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate): Alternate Analysis
timeFrame: 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)
measure: Number of Mothers With Adverse Events (AEs) During Follow-up
timeFrame: 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)
measure: Number of Mothers With Serious AEs (SAEs) During Follow-up
timeFrame: 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)
measure: Number of Infants With AEs During Follow-up
timeFrame: From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to 12 weeks after birth on current follow-up study
measure: Number of Infants With SAEs During Follow-up
timeFrame: From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to 12 weeks after birth on current follow-up study
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.