Trials / Completed
CompletedNCT03758885
Study of Nolasiban to Increase Pregnancy Rates in Women Undergoing IVF
A Phase 3, Double-blind, Randomized, Placebo-controlled Study to Assess the Safety and Efficacy of a Single Oral Administration of Nolasiban to Increase On-going Pregnancy Rate Following Fresh Single Blastocyst Transfer Resulting From IVF
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 820 (actual)
- Sponsor
- ObsEva SA · Industry
- Sex
- Female
- Age
- 18 Years – 37 Years
- Healthy volunteers
- Not accepted
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 (ET) day.
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 live birth rates in 820 women undergoing fresh single blastocyst transfer following in vitro fertilisation (IVF) or intra-cytoplasmic sperm injection (ICSI).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Nolasiban | Nolasiban single oral administration |
| DRUG | Placebo | Placebo single oral administration |
Timeline
- Start date
- 2019-01-10
- Primary completion
- 2019-11-21
- Completion
- 2020-11-11
- First posted
- 2018-11-29
- Last updated
- 2021-09-09
Locations
50 sites across 10 countries: Belgium, Canada, Czechia, Denmark, Estonia, Germany, Hungary, Poland, Russia, Spain
Source: ClinicalTrials.gov record NCT03758885. Inclusion in this directory is not an endorsement.