N/A
N=8
Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05693 (P05713)
Pregnancy · Neonates
Bottom Line
View on ClinicalTrials.gov: NCT00702338 ↗Enrolled (actual)
8
Serious AEs
100.0%
Results posted
Jun 2014
Primary outcome: Primary: Percentage of Mothers With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate): Protocol Defined — 0.0; 33.3 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- corifollitropin alfa (Drug); recombinant Follicle Stimulating Hormone (recFSH) (Biological); human Chorion Gonadotropin (hCG) (Biological); hCG Bolus injection (Biological)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Organon and Co
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Mothers With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate): Protocol Defined |
0.0; 33.3 | — |
| PRIMARY Percentage of Mothers With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate): Alternate Analysis |
0.0; 100.0 | — |
| PRIMARY Number of Mothers With Adverse Events (AEs) During Follow-up |
1 | — |
| PRIMARY Number of Mothers With Serious AEs (SAEs) During Follow-up |
1 | — |
| PRIMARY Number of Infants With AEs During Follow-up |
2 | — |
| PRIMARY Number of Infants With SAEs During Follow-up |
2 | — |
Summary
The objective of follow-up study P05713 is to evaluate whether corifollitropin alfa (Org 36286) treatment for the induction of monofollicular growth in women who underwent ovulation induction (OI) in base study P05693 (NCT00697255) is safe for pregnant participants and their offspring.
Eligibility Criteria
Inclusion Criteria
- Participants who participated in base study P05693 (NCT00697255) and received at least one dose of corifollitropin alfa
- Ongoing pregnancy confirmed by ultrasound at least 10 weeks after bolus injection of hCG in base study P05693
- Able and willing to give written informed consent (informed consent is
incorporated in the informed consent form of protocol P05693)
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT00702338). 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.