Clinical trial NCT00702234: Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05714 (Care Program)(P05715)
Official title: Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established After Controlled Ovarian Stimulation in Clinical Trial 38825 for Org 36286 (Corifollitropin Alfa)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Neonates
Keywords: Neonatal outcome
Congenital malformations
In-Vitro fertilization
Controlled ovarian stimulation
Follow-up
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-06-20
Enrollment: 268
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 fresh embryo transfer in base study P05714 (NCT00696878) were enrolled in this trial.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Women With Ongoing Pregnancy After a Corifollitropin Alfa COS Cycle in Base Study and ≥1 Live Born Infant During Follow-up (Live Birth Rate)
timeFrame: Up to approximately 32 months after first dose of corifollitropin alfa in base study P05714 (NCT00696878)
measure: Number of Expectant Mothers Experiencing Adverse Events (AEs)
timeFrame: From approximately 10 weeks after fresh ET in base study P05714 up to birth of infant (up to approximately 6 months)
measure: Number of Expectant Mothers Experiencing Serious AEs (SAEs)
timeFrame: From approximately 10 weeks after fresh ET in base study P05714 up to birth of infant (up to approximately 6 months)
measure: Number of Live Born Infants Experiencing AEs
timeFrame: Up to 12 weeks after birth
measure: Number of Live Born Infants Experiencing SAEs
timeFrame: Up to 12 weeks after birth
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
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.