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Completed

NCT Number: NCT03081208

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

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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year–36 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Investigator ID 1001, Brussels, Belgium

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About this study

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).

Who can participate

Healthy volunteers accepted: No

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

Key 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

Treatment and study plan

Nolasiban 900mg

Drug

Nolasiban dispersible tablets for single oral administration

Placebo

Drug

Placebo dispersible tablets for single oral administration

Primary outcomes

  1. Intra-uterine pregnancy with fetal heart beat at 10 weeks

    Time frame: 10 weeks post ET day

    Intra-uterine pregnancy with fetal heart beat at 10 weeks post embryo transfer day

Secondary outcomes

  1. Live birth

    Time frame: Up to 42 weeks of gestation

    Live birth after 24 weeks of gestation

  2. Miscarriage

    Time frame: From 6 weeks post ET to 24 weeks gestation

    Any clinical pregnancy that does not result in a live birth prior 24 weeks

  3. Intra-uterine pregnancy at 6 weeks

    Time frame: 6 weeks post ET

    Intra-uterine pregnancy with fetal heart beat at 6 weeks post ET day

  4. Positive blood pregnancy test

    Time frame: 14 days post OPU

    Positive blood pregnancy test at 14 days post oocyte pick-up (OPU)

Other outcomes

  1. Adverse events

    Time frame: Through study completion, up to 11 months

    Frequency and severity of treatment emergent adverse events

  2. Neonatal assessments

    Time frame: Birth of infant until 28 days

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

  3. ASQ-3

    Time frame: 6 months after term

    Ages and Stages Questionnaire-3 (ASQ-3) domain score(s) at 6 months, adjusted for gestational age at birth

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 Efficacy and Safety of a Single Oral Administration of Nolasiban to Improve Pregnancy Rates Following IVF or ICSI in Day 3 and Day 5 Fresh Embryo Transfer Cycles

Acronym: IMPLANT2

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Mar 16, 2017
Registry last updated
Dec 23, 2019

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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