Study of Nolasiban to Increase Pregnancy Rates in Women Undergoing IVF

NCT ID: NCT03758885

Last Updated: 2021-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

820 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-10

Study Completion Date

2020-11-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Infertility

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Nolasiban 900 mg

Nolasiban dispersible tablets for single oral administration

Group Type EXPERIMENTAL

Nolasiban

Intervention Type DRUG

Nolasiban single oral administration

Placebo

Placebo dispersible tablets for single oral administration

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo single oral administration

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nolasiban

Nolasiban single oral administration

Intervention Type DRUG

Placebo

Placebo single oral administration

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

37 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

ObsEva SA

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Site 1001

Brussels, , Belgium

Site Status

Site 1002

Brussels, , Belgium

Site Status

Site 1003

Brussels, , Belgium

Site Status

Site 1004

Brussels, , Belgium

Site Status

Site 1404

Burnaby, , Canada

Site Status

Site 1401

Montreal, , Canada

Site Status

Site 1402

Toronto, , Canada

Site Status

Site 1403

Toronto, , Canada

Site Status

Site 1107

Olomouc, , Czechia

Site Status

Site 1101

Prague, , Czechia

Site Status

Site 1102

Prague, , Czechia

Site Status

Site 1103

Prague, , Czechia

Site Status

Site 1104

Prague, , Czechia

Site Status

Site 1105

Prague, , Czechia

Site Status

Site 1108

Prague, , Czechia

Site Status

Site 1110

Prague, , Czechia

Site Status

Site 1109

Teplice, , Czechia

Site Status

Site 1106

Zlín, , Czechia

Site Status

Site 1204

Copenhagen, , Denmark

Site Status

Site 1205

Herlev, , Denmark

Site Status

Site 1202

Hvidovre, , Denmark

Site Status

Site 1203

Skive, , Denmark

Site Status

Site 1302

Tallinn, , Estonia

Site Status

Site 1301

Tartu, , Estonia

Site Status

Site 1303

Tartu, , Estonia

Site Status

Site 1504

Berlin, , Germany

Site Status

Site 1506

Berlin, , Germany

Site Status

Site 1505

Bielefeld, , Germany

Site Status

Site 1501

Heidelberg, , Germany

Site Status

Site 1502

Lübeck, , Germany

Site Status

Site 1503

Marburg, , Germany

Site Status

Site 1601

Budapest, , Hungary

Site Status

Site 1603

Budapest, , Hungary

Site Status

Site 1602

Tapolca, , Hungary

Site Status

Site 1703

Bialystok, , Poland

Site Status

Site 1705

Bialystok, , Poland

Site Status

Site 1702

Katowice, , Poland

Site Status

Site 1701

Krakow, , Poland

Site Status

Site 1704

Szczecin, , Poland

Site Status

Site 1706

Warsaw, , Poland

Site Status

Site 1901

Moscow, , Russia

Site Status

Site 1905

Moscow, , Russia

Site Status

Site 1904

Samara, , Russia

Site Status

Site 1902

Yekaterinburg, , Russia

Site Status

Site 1805

Barcelona, , Spain

Site Status

Site 1808

Barcelona, , Spain

Site Status

Site 1809

Leioa, , Spain

Site Status

Site 1804

Madrid, , Spain

Site Status

Site 1807

Madrid, , Spain

Site Status

Site 1811

Seville, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium Canada Czechia Denmark Estonia Germany Hungary Poland Russia Spain

References

Explore related publications, articles, or registry entries linked to this study.

Griesinger G, Blockeel C, Pierzynski P, Tournaye H, Visnova H, Humberstone A, Terrill P, Pohl O, Garner E, Donnez J, Loumaye E. Effect of the oxytocin receptor antagonist nolasiban on pregnancy rates in women undergoing embryo transfer following IVF: analysis of three randomised clinical trials. Hum Reprod. 2021 Mar 18;36(4):1007-1020. doi: 10.1093/humrep/deaa369.

Reference Type DERIVED
PMID: 33534895 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

18-OBE001-010

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.