Phase 3
N=1,390
Frozen-thawed Embryo Transfer (FTET) Cycle Follow-up Protocol (P06031)
Infertility
Bottom Line
View on ClinicalTrials.gov: NCT01146418 ↗Enrolled (actual)
1,390
Serious AEs
19.7%
Results posted
Feb 2016
Primary outcome: Primary: Percentage of Participants With ≥1 Vital Pregnancy (Cumulative Vital Pregnancy Rate) — 31.1; 33.0 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Corifollitropin alfa (Biological); recFSH (follitropin beta) (Biological)
- Age
- Adult · 35+ yrs
- Sex
- Female
- Sponsor
- Organon and Co
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With ≥1 Vital Pregnancy (Cumulative Vital Pregnancy Rate) |
31.1; 33.0 | — |
| SECONDARY Percentage of Participants With ≥1 Live Birth (Cumulative Live-Birth Rate) |
28.2; 29.5 | — |
Summary
The purpose of this follow-up study is to collect the outcome and safety of FTET cycles after the embryos are cryopreserved in P06029 (NCT01144416). P06029 was a study in which a single injection of corifollitropin alfa (SCH 900962) was compared with daily recombinant follicle stimulating hormone (recFSH) injections in women aged 35 to 42 years undergoing controlled ovarian stimulation (COS) prior to in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).
Eligibility Criteria
Inclusion Criteria
- Participant must have provided written informed consent for the trial.
- Participant must have cryopreserved embryo(s) in trial P06029 (NCT01144416) of which at least one embryo is thawed for use in a subsequent FTET cycle.
Data sourced from ClinicalTrials.gov (NCT01146418). 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.