Clinical trial NCT00702624: Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05690 (Care Program) (P05710)
Official title: Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established After Controlled Ovarian Stimulation in Clinical Trial 107012 for the Development of 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: 113
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 36
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 embryo transfer in base study P05690 (NCT00702845) were enrolled in this trial.

Brief summary: The objective of this follow-up study 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.

Detailed description: This is a follow-up protocol to prospectively monitor pregnancy, delivery, and neonatal outcome of women who were treated with corifollitropin alfa or recFSH and became pregnant during the base study P05690 (NCT00702845). 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 P05690 (NCT00702845) and received at least one dose of either corifollitropin alfa (Org 36286) or recFSH in base study P05690;
* Ongoing pregnancy confirmed by ultrasound at least 10 weeks after embryo transfer in base study P05690;
* Able and willing to give written informed consent.

Exclusion Criteria:

* None

Primary outcomes:
measure: Percentage of Women With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate)
timeFrame: From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months)
measure: Number of Expectant Mothers Experiencing Adverse Events (AEs)
timeFrame: From approximately 10 weeks after ET in base study P05690 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 ET in base study P05690 up to birth of infant (up to approximately 6 months)
measure: Number of Infants Experiencing AEs
timeFrame: Up to 12 weeks after birth
measure: Number of 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.