Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05714 (Care Program)(P05715)

Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established After Controlled Ovarian Stimulation in Clinical Trial 38825 for Org 36286 (Corifollitropin Alfa)

The objective of this trial is to evaluate whether corifollitropin alfa (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. In addition, a primary efficacy variable, live birth rate, was evaluated.

This is a follow-up protocol to prospectively monitor pregnancy, delivery, and neonatal outcomes of women who were treated with corifollitropin alfa and became pregnant after fresh embryo transfer during the base study P05714 (NCT00696878). For this trial, no study specific assessments are required, but information as obtained in standard practice will be used.

Inclusion Criteria:

• Participants who participated in base study P05714 (NCT00696878) and received at least one dose of corifollitropin alfa in base study P05714;
• Ongoing pregnancy confirmed by ultrasound at least 10 weeks after a fresh embryo transfer in base study P05714;
• Able and willing to give written informed consent.

Exclusion Criteria:

• None