Status:
COMPLETED
Study of Nolasiban to Increase Pregnancy Rates in Women Undergoing IVF
Lead Sponsor:
ObsEva SA
Conditions:
Infertility
Eligibility:
FEMALE
18-37 years
Phase:
PHASE3
Brief Summary
The primary objective of this study is to confirm the efficacy of a single oral 900 mg dose of nolasiban versus placebo to increase the ongoing clinical pregnancy rate at 10 weeks post-embryo transfer...
Detailed Description
The study is a prospective, randomised, parallel group, double-blind, placebo-controlled, Phase 3 study to confirm the efficacy and the safety of nolasiban versus placebo to increase pregnancy and liv...
Eligibility Criteria
Inclusion
- Indicated for IVF/ICSI in the context of assisted reproductive technology (ART)
- Follow a gonadotropin releasing hormone (GnRH) antagonist protocol, single injection of human chorionic gonadotropin (hCG) for triggering final follicular maturation and luteal support with vaginal micronized progesterone.
- Single fresh D5 embryo transfer
Exclusion
- Frozen-thawed embryo transfer
- Donor egg in the current transfer
- More than 20 oocytes in the current controlled ovarian hyperstimulation (COH) cycle
- Serum P4 greater than 1.5 ng/mL prior to hCG administration
Key Trial Info
Start Date :
January 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 11 2020
Estimated Enrollment :
820 Patients enrolled
Trial Details
Trial ID
NCT03758885
Start Date
January 10 2019
End Date
November 11 2020
Last Update
September 9 2021
Active Locations (50)
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1
Site 1001
Brussels, Belgium
2
Site 1002
Brussels, Belgium
3
Site 1003
Brussels, Belgium
4
Site 1004
Brussels, Belgium