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OpenTrials
Completed

NCT Number: NCT03758885

Study of Nolasiban to Increase Pregnancy Rates in Women Undergoing 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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year–37 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Site 1001, Brussels, Belgium

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nolasiban

Drug

Nolasiban single oral administration

Placebo

Drug

Placebo single oral administration

Primary outcomes

  1. 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

Secondary outcomes

  1. Live birth

    Time frame: 24 to 40 weeks of gestation

    Live birth after 24 weeks of gestation

  2. 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

  3. 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

  4. 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

  5. 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

Other outcomes

  1. Adverse events

    Time frame: Through study completion, up to 11 months

    Treatment emergent adverse events frequency and severity

  2. Neonatal assessments

    Time frame: Birth of infant until 28 days

    Incidence of any malformation or any significant morbidity during the neonatal period

  3. 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.

Sponsors and collaborators

Lead sponsor

ObsEva SA

Industry

Registry information

Official study title

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

Acronym: IMPLANT4

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Nov 29, 2018
Registry last updated
Sep 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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