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

Phase 3

Completed

• Conditions: Infertility
• Interventions: Drug: Nolasiban 900mg; Drug: Placebo

• Registration Number: NCT03081208
• Lead Sponsor: ObsEva SA

Brief 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).

Study Timeline

• Study Start: 2017-03-06
• Study First Submitted: 2017-03-06
• Study First Submitted QC: 2017-03-09
• Study First Posted: 2017-03-16
• Primary Completion: 2018-03-21
• Study Completion: 2019-02-19
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-20
• Last Update Posted: 2019-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 810

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 phase support with vaginal micronized progesterone.
• Single, fresh D3 or D5 embryo transfer

Key

Exclusion Criteria

• Frozen-thawed embryo transfer
• More than 20 oocytes in the current controlled ovarian hyperstimulation (COH) cycle
• Serum P4 greater than 1.5 ng/mL on the day of hCG administration

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nolasiban 900 mg	Nolasiban 900mg	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Intra-uterine pregnancy with fetal heart beat at 10 weeks	10 weeks post ET day	Intra-uterine pregnancy with fetal heart beat at 10 weeks post embryo transfer day

Secondary Outcome Measures

Name	Time	Method
Live birth	Up to 42 weeks of gestation	Live birth after 24 weeks of gestation
Miscarriage	From 6 weeks post ET to 24 weeks gestation	Any clinical pregnancy that does not result in a live birth prior 24 weeks
Intra-uterine pregnancy at 6 weeks	6 weeks post ET	Intra-uterine pregnancy with fetal heart beat at 6 weeks post ET day
Positive blood pregnancy test	14 days post OPU	Positive blood pregnancy test at 14 days post oocyte pick-up (OPU)

Trial Locations

Locations (43)

Investigator ID 1604; 🇭🇺 Budapest, Hungary

Investigator ID 1003; 🇧🇪 Brussels, Belgium

Investigator ID 1603; 🇭🇺 Pécs, Hungary

Investigator ID 1601; 🇭🇺 Budapest, Hungary

Investigator ID 1705; 🇵🇱 Białystok, Poland

Investigator ID 1602; 🇭🇺 Tapolca, Hungary

Investigator ID 1703; 🇵🇱 Białystok, Poland

Investigator ID 1403; 🇫🇮 Oulu, Finland

Investigator ID 1203; 🇩🇰 Skive, Denmark

Investigator ID 1301; 🇪🇪 Tartu, Estonia

Investigator ID 1002; 🇧🇪 Brussels, Belgium

Investigator ID 1004; 🇧🇪 Brussels, Belgium

Investigator ID 1402; 🇫🇮 Helsinki, Finland

Investigator ID 1504; 🇩🇪 Mainz, Germany

Investigator ID 1205; 🇩🇰 Herlev, Denmark

Investigator ID 1104; 🇨🇿 Prague, Czechia

Investigator ID 1109; 🇨🇿 Teplice, Czechia

Investigator ID 1503; 🇩🇪 Marburg, Germany

Investigator ID 1701; 🇵🇱 Białystok, Poland

Investigator ID 1704; 🇵🇱 Szczecin, Poland

Investigator ID 1501; 🇩🇪 Heidelberg, Germany

Investigator ID 1808; 🇪🇸 Barcelona, Spain

Investigator ID 1401; 🇫🇮 Helsinki, Finland

Investigator ID 1303; 🇪🇪 Tartu, Estonia

Investigator ID 1108; 🇨🇿 Prague, Czechia

Investigator ID 1202; 🇩🇰 Hvidovre, Denmark

Investigator ID 1204; 🇩🇰 Copenhagen, Denmark

Investigator ID 1502; 🇩🇪 Lübeck, Germany

Investigator ID 1702; 🇵🇱 Katowice, Poland

Investigator ID 1706; 🇵🇱 Warsaw, Poland

Investigator ID 1801; 🇪🇸 Barakaldo, Spain

Investigator ID 1809; 🇪🇸 Leioa, Spain

Investigator ID 1806; 🇪🇸 Valencia, Spain

Investigator ID 1804; 🇪🇸 Madrid, Spain

Investigator ID 1807; 🇪🇸 Madrid, Spain

Investigator ID 1811; 🇪🇸 Sevilla, Spain

Investigator ID 1106; 🇨🇿 Zlin, Czechia

Investigator ID 1001; 🇧🇪 Brussels, Belgium

Investigator ID 1102; 🇨🇿 Prague, Czechia

Investigator ID 1101; 🇨🇿 Prague, Czechia

Investigator ID 1103; 🇨🇿 Prague, Czechia

Investigator ID 1107; 🇨🇿 Olomouc, Czechia

Investigator ID 1805; 🇪🇸 Barcelona, Spain