Study of Nolasiban to Increase Pregnancy Rates in Women Undergoing IVF (IMPLANT4)

September 8, 2021 updated by: ObsEva SA

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

820

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussel, Belgium
        • Site 1002
      • Brussels, Belgium
        • Site 1001
      • Brussels, Belgium
        • Site 1003
      • Brussels, Belgium
        • Site 1004
  • Canada
      • Burnaby, Canada
        • Site 1404
      • Montréal, Canada
        • Site 1401
      • Toronto, Canada
        • Site 1402
      • Toronto, Canada
        • Site 1403
  • Czechia
      • Olomouc, Czechia
        • Site 1107
      • Praha, Czechia
        • Site 1101
      • Praha, Czechia
        • Site 1102
      • Praha, Czechia
        • Site 1103
      • Praha, Czechia
        • Site 1104
      • Praha, Czechia
        • Site 1105
      • Praha, Czechia
        • Site 1108
      • Praha, Czechia
        • Site 1110
      • Teplice, Czechia
        • Site 1109
      • Zlín, Czechia
        • Site 1106
  • Denmark
      • Herlev, Denmark
        • Site 1205
      • Hvidovre, Denmark
        • Site 1202
      • Kobenhavn, Denmark
        • Site 1204
      • Skive, Denmark
        • Site 1203
  • Estonia
      • Tallinn, Estonia
        • Site 1302
      • Tartu, Estonia
        • Site 1301
      • Tartu, Estonia
        • Site 1303
  • Germany
      • Berlin, Germany
        • Site 1504
      • Berlin, Germany
        • Site 1506
      • Bielefeld, Germany
        • Site 1505
      • Heidelberg, Germany
        • Site 1501
      • Lubeck, Germany
        • Site 1502
      • Marburg, Germany
        • Site 1503
  • Hungary
      • Budapest, Hungary
        • Site 1601
      • Budapest, Hungary
        • Site 1603
      • Tapolca, Hungary
        • Site 1602
  • Poland
      • Białystok, Poland
        • Site 1703
      • Białystok, Poland
        • Site 1705
      • Katowice, Poland
        • Site 1702
      • Kraków, Poland
        • Site 1701
      • Szczecin, Poland
        • Site 1704
      • Warsaw, Poland
        • Site 1706
  • Russian Federation
      • Ekaterinburg, Russian Federation
        • Site 1902
      • Moscow, Russian Federation
        • Site 1901
      • Moscow, Russian Federation
        • Site 1905
      • Samara, Russian Federation
        • Site 1904
  • Spain
      • Barcelona, Spain
        • Site 1805
      • Barcelona, Spain
        • Site 1808
      • Leioa, Spain
        • Site 1809
      • Madrid, Spain
        • Site 1804
      • Madrid, Spain
        • Site 1807
      • Sevilla, Spain
        • Site 1811

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 37 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Nolasiban 900 mg
Nolasiban dispersible tablets for single oral administration
Drug: Nolasiban
Nolasiban single oral administration
PLACEBO_COMPARATOR: Placebo
Placebo dispersible tablets for single oral administration
Drug: Placebo
Placebo single oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ongoing pregnancy with fetal heart beat at 10 weeks
Time Frame: 10 weeks post ET day
Ongoing pregnancy defined as an intra-uterine pregnancy with fetal heart beat at 10 weeks post embryo transfer day
10 weeks post ET day

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neonatal assessments
Time Frame: Birth of infant until 28 days
Incidence of any malformation or any significant morbidity during the neonatal period
Birth of infant until 28 days
Adverse events
Time Frame: Through study completion, up to 11 months
Treatment emergent adverse events frequency and severity
Through study completion, up to 11 months
Ages and Stages Questionnaires® (ASQ-3™) 6 and 12 month Questionnaire
Time Frame: 6 and 12 months after term
Screening questionnaire composed of 30 questions completed by the parent. Questions are divided into five areas: communication, gross motor, fine motor, problem solving and personal-social. Parents respond yes, sometimes and not yet to questions, these are converted to points 10, 5 and 0 for scoring and are totalled for each developmental area. These 5 area scores are compared with empirically derived cutoff points.
6 and 12 months after term

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ObsEva SA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 10, 2019

Primary Completion (ACTUAL)

November 21, 2019

Study Completion (ACTUAL)

November 11, 2020

Study Registration Dates

First Submitted

November 28, 2018

First Submitted That Met QC Criteria

November 28, 2018

First Posted (ACTUAL)

November 29, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 9, 2021

Last Update Submitted That Met QC Criteria

September 8, 2021

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-OBE001-010

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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