N/A N=50

Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial 38833 (P05783)

Pregnancy · Neonates

Bottom Line

View on ClinicalTrials.gov: NCT00702520 ↗

Enrolled (actual)

Serious AEs

50.0%

Results posted

Jun 2014

Primary outcome: Primary: Number of Expectant Mothers Experiencing Adverse Events (AEs) — 7; 6 Participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Corifollitropin alpha (MK-8962, Org 36286) 100 ug (Drug); Corifollitropin alpha (MK-8962, Org 36286) 150 ug (Drug); Triptorelin (Drug); Recombinant follicle stimulating hormone (recFSH) (Biological); Human chorionic gonadotprophin (hCG). (Biological)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Organon and Co
Primary completion: Nov 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Expectant Mothers Experiencing Adverse Events (AEs)	7; 6	—
PRIMARY Number of Expectant Mothers Experiencing Serious AEs (SAEs)	2; 2	—
PRIMARY Number of Infants Experiencing AEs	6; 11	—
PRIMARY Number of Infants Experiencing SAEs	6; 7	—
PRIMARY Take-Home Baby Rate	28.0; 33.3	—

Summary

The objective of this trial is to evaluate whether corifollitropin alfa (MK-8962, 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.

Eligibility Criteria

Inclusion Criteria

Participants who received one dose of corifollitropin alfa in Trial 38833;
Ongoing pregnancy confirmed by ultrasound at least 10 weeks after embryo transfer in Trial 38833;
Able and willing to give written informed consent.

Exclusion Criteria

None

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00702520). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.