NCT03081208

Phase 3 Placebo Controlled Study of Nolasiban to Improve Pregnancy Rates in Women Undergoing IVF/ICSI

A Phase 3, Double-blind, Randomized, Placebo-controlled Study to Assess the Efficacy and Safety of a Single Oral Administration of Nolasiban to Improve Pregnancy Rates Following IVF or ICSI in Day 3 and Day 5 Fresh Embryo Transfer Cycles

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 810 (actual)
• Sponsor: ObsEva SA · Industry
• Sex: Female
• Age: 18 Years – 36 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to confirm the efficacy of a single oral 900mg dose of nolasiban to increase the ongoing clinical pregnancy rate at 10 weeks post embryo transfer (ET) day.

Detailed description

The study is a prospective, randomized, parallel group, double-blind, placebo-controlled study to confirm the efficacy and the safety of the oxytocin receptor antagonist, nolasiban, in 760 women undergoing fresh embryo transfer following in vitro fertilisation (IVF) or intra-cytoplasmic sperm injection (ICSI).

Conditions

• Infertility

Interventions

Type	Name	Description
DRUG	Nolasiban 900mg	Nolasiban dispersible tablets for single oral administration
DRUG	Placebo	Placebo dispersible tablets for single oral administration

Timeline

• Start date: 2017-03-06
• Primary completion: 2018-03-21
• Completion: 2019-02-19
• First posted: 2017-03-16
• Last updated: 2019-12-23

Locations

43 sites across 9 countries: Belgium, Czechia, Denmark, Estonia, Finland, Germany, Hungary, Poland, Spain