N/A
N=396
Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05690 (Care Program) (P05710)
Pregnancy · Neonates
Bottom Line
View on ClinicalTrials.gov: NCT00702624 ↗Enrolled (actual)
396
Serious AEs
41.4%
Results posted
Apr 2015
Primary outcome: Primary: Percentage of Women With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate) — 23.5; 34.4 Percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Corifollitropin alfa (Drug); recFSH (follitropin beta) (Biological); gonadatropin releasing hormone (GnRH) antagonist ganirelix (Drug); human chorion gonadotropin (hCG) (Biological); progesterone (Biological); placebo-recFSH (follitropin beta) (Drug); placebo-corifollitropin alfa (Drug); open-label recFSH (follitropin beta) (Biological)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Organon and Co
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Women With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate) |
23.5; 34.4 | — |
| PRIMARY Number of Expectant Mothers Experiencing Adverse Events (AEs) |
48; 35 | — |
| PRIMARY Number of Expectant Mothers Experiencing Serious AEs (SAEs) |
38; 21 | — |
| PRIMARY Number of Infants Experiencing AEs |
37; 27 | — |
| PRIMARY Number of Infants Experiencing SAEs |
30; 16 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00702624). 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.