Study of Nolasiban to Increase Pregnancy Rates in Women Undergoing IVF

Phase 3

Completed

• Conditions: Infertility
• Interventions: Drug: Nolasiban; Drug: Placebo

• Registration Number: NCT03758885
• Lead Sponsor: ObsEva SA

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 (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).

Study Timeline

• Study First Submitted: 2018-11-28
• Study First Submitted QC: 2018-11-28
• Study First Posted: 2018-11-29
• Study Start: 2019-01-10
• Primary Completion: 2019-11-21
• Status Verified: 2020-09
• Study Completion: 2020-11-11
• Last Update Submitted: 2021-09-08
• Last Update Posted: 2021-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 820

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nolasiban 900 mg	Nolasiban	Nolasiban dispersible tablets for single oral administration
Placebo	Placebo	Placebo dispersible tablets for single oral administration

Primary Outcome Measures

Name	Time	Method
Ongoing pregnancy with fetal heart beat at 10 weeks	10 weeks post ET day	Ongoing pregnancy defined as an intra-uterine pregnancy with fetal heart beat at 10 weeks post embryo transfer day

Secondary Outcome Measures

Name	Time	Method
Clinical pregnancy at 6 weeks post ET day	6 weeks post ET	Clinical pregnancy defined as intra-uterine pregnancy with fetal heart beat at 6 weeks post-ET day
Live birth	24 to 40 weeks of gestation	Live birth after 24 weeks of gestation
Plasma concentrations of nolasiban	3.5 hours, 5 hours and at 7 hours (latest 72 hours) after nolasiban administration	Plasma concentrations of nolasiban after administration
Pregnancy rate at 14 days post Oocyte Pick-up (OPU)	14 days post OPU	Positive blood pregnancy test at 14 days post OPU day
Pregnancy loss	6 weeks post ET to 24 weeks gestation	Pregnancy loss at 6 or 10 weeks after ET and before 24 weeks of gestation

Trial Locations

Locations (50)

Site 1004; 🇧🇪 Brussels, Belgium

Site 1109; 🇨🇿 Teplice, Czechia

Site 1706; 🇵🇱 Warsaw, Poland

Site 1103; 🇨🇿 Praha, Czechia

Site 1108; 🇨🇿 Praha, Czechia

Site 1001; 🇧🇪 Brussels, Belgium

Site 1402; 🇨🇦 Toronto, Canada

Site 1102; 🇨🇿 Praha, Czechia

Site 1003; 🇧🇪 Brussels, Belgium

Site 1601; 🇭🇺 Budapest, Hungary

Site 1807; 🇪🇸 Madrid, Spain

Site 1104; 🇨🇿 Praha, Czechia

Site 1106; 🇨🇿 Zlín, Czechia

Site 1603; 🇭🇺 Budapest, Hungary

Site 1901; 🇷🇺 Moscow, Russian Federation

Site 1303; 🇪🇪 Tartu, Estonia

Site 1702; 🇵🇱 Katowice, Poland

Site 1701; 🇵🇱 Kraków, Poland

Site 1203; 🇩🇰 Skive, Denmark

Site 1506; 🇩🇪 Berlin, Germany

Site 1502; 🇩🇪 Lubeck, Germany

Site 1808; 🇪🇸 Barcelona, Spain

Site 1301; 🇪🇪 Tartu, Estonia

Site 1602; 🇭🇺 Tapolca, Hungary

Site 1904; 🇷🇺 Samara, Russian Federation

Site 1205; 🇩🇰 Herlev, Denmark

Site 1805; 🇪🇸 Barcelona, Spain

Site 1809; 🇪🇸 Leioa, Spain

Site 1503; 🇩🇪 Marburg, Germany

Site 1101; 🇨🇿 Praha, Czechia

Site 1302; 🇪🇪 Tallinn, Estonia

Site 1804; 🇪🇸 Madrid, Spain

Site 1504; 🇩🇪 Berlin, Germany

Site 1202; 🇩🇰 Hvidovre, Denmark

Site 1902; 🇷🇺 Ekaterinburg, Russian Federation

Site 1204; 🇩🇰 Kobenhavn, Denmark

Site 1401; 🇨🇦 Montréal, Canada

Site 1404; 🇨🇦 Burnaby, Canada

Site 1107; 🇨🇿 Olomouc, Czechia

Site 1403; 🇨🇦 Toronto, Canada

Site 1105; 🇨🇿 Praha, Czechia

Site 1110; 🇨🇿 Praha, Czechia

Site 1501; 🇩🇪 Heidelberg, Germany

Site 1505; 🇩🇪 Bielefeld, Germany

Site 1703; 🇵🇱 Białystok, Poland

Site 1704; 🇵🇱 Szczecin, Poland

Site 1905; 🇷🇺 Moscow, Russian Federation

Site 1811; 🇪🇸 Sevilla, Spain

Site 1705; 🇵🇱 Białystok, Poland

Site 1002; 🇧🇪 Brussel, Belgium