N/A
N=682
Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05714 (Care Program)(P05715)
Pregnancy · Neonates
Bottom Line
View on ClinicalTrials.gov: NCT00702234 ↗Enrolled (actual)
682
Serious AEs
39.3%
Results posted
Apr 2015
Primary outcome: Primary: 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) — 37.8 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Corifollitropin alfa (Biological); GnRH antagonist (Biological); (rec)hCG (Biological); FSH (Biological); Progesterone (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Organon and Co
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
37.8 | — |
| PRIMARY Number of Expectant Mothers Experiencing Adverse Events (AEs) |
203 | — |
| PRIMARY Number of Expectant Mothers Experiencing Serious AEs (SAEs) |
145 | — |
| PRIMARY Number of Live Born Infants Experiencing AEs |
99 | — |
| PRIMARY Number of Live Born Infants Experiencing SAEs |
79 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00702234). 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.