N/A
Completed N=50
Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial 38833 (P05783)
Pregnancy · Neonates
Source: ClinicalTrials.gov NCT00702520 ↗
Enrolled (actual)
50
Serious AEs
50.0%
Results posted
Jun 2014
Primary outcomePrimary: Number of Expectant Mothers Experiencing Adverse Events (AEs) — 7; 6 Participants
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.
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 | — |
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
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. Informational only — not medical advice.