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

Pregnancy Clinical Trial

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)

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00702338
Study type Observational
Source Organon and Co
Contact
Status Completed
Phase
Start date May 15, 2008
Completion date December 15, 2008
View Details
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