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Completed

NCT Number: NCT02310802

OBE001 Phase 2 Dose-finding Study Versus Placebo in Women Undergoing Embryo Transfer in the Context of IVF-ICSI

The primary objective of this study is to assess the increase in clinical pregnancy rate after administration of a range of single oral doses of OBE001, an oral oxytocin antagonist, compared to placebo.

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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 2

Primary location

Brussels, Belgium

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About this study

The study is a prospective, dose-finding, randomised, parallel group, double-blind, placebo-controlled study investigating the efficacy and the safety of the oxytocin receptor antagonist OBE001 in 240 women undergoing embryo transfer following IVF or ICSI.

The four-arm study (OBE001 dose 1, dose 2, dose 3, and placebo) design will allow evaluation of a possible dose-dependent pattern of action of OBE001 and, simultaneously, comparison of active compound with placebo with regard to both efficacy and safety.

Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria

  • Women with medically indicated IVF or ICSI using her own oocytes.
  • GnRH antagonist protocol, a single injection of hCG for triggering final follicular maturation and luteal phase support with vaginal micronized progesterone.
  • Evidence of uterine contractions by transvaginal ultrasound at baseline.

Key Exclusion Criteria

  • Blastocyst stage or frozen-thaw transfers
  • Clinically significant abnormalities in ECG, vital signs, physical examination or clinical laboratory results
  • Severe endometriosis and/or adenomyosis or risk of ovarian hyper stimulation syndrome

Treatment and study plan

OBE001 dose 1

Drug

OBE001 dispersible tablets for single oral administration

OBE001 dose 2

Drug

OBE001 dispersible tablets for single oral administration

OBE001 dose 3

Drug

OBE001 dispersible tablets for single oral administration

Placebo

Drug

Placebo dispersible tablets for single oral administration

Primary outcomes

  1. EFFICACY ENDPOINTS Percentage of women with an intra-uterine pregnancy with positive embryo heart-beat

    Time frame: about 6 weeks post ET day

    Percentage of women with an intra-uterine pregnancy with positive embryo heart-beat at about 6 weeks post ET day.

Secondary outcomes

  1. EFFICACY ENDPOINTS Percentage of women with positive blood pregnancy test

    Time frame: 14 days post OPU day

    Percentage of women with positive blood pregnancy test at 14 days post OPU day.

  2. EFFICACY ENDPOINTS Percentage of women with an intra-uterine pregnancy with positive embryo heart-beat

    Time frame: 10 weeks post OPU day

    Percentage of women with an intra-uterine pregnancy with positive embryo heart-beat at 10 weeks post OPU day.

  3. EFFICACY ENDPOINTS The embryo-implantation rate

    Time frame: 6 weeks post ET day

    The embryo-implantation rate defined as the number of intra-uterine embryos with positive heart-beat at 6 weeks post ET day divided by the number of embryos transferred

  4. EFFICACY ENDPOINTS Change from baseline to the time of ET in the rate of uterine contractions

    Time frame: at 3.5 hours after dose administration

    Change from baseline to the time of ET in the rate of uterine contractions (UC/min).

Other outcomes

  1. SAFETY ENDPOINTS Treatment emergent adverse events frequency and severity

    Time frame: up to 10 weeks post OPU day

    Treatment emergent adverse events frequency and severity

  2. SAFETY ENDPOINTS (Haematology and biochemistry assessments)

    Time frame: 14 days post OPU day

    Haematology and biochemistry assessments at screening and at visit V3 (14 days post OPU day)

  3. PHARMACOKINETIC ENDPOINTS Plasma levels of OBE001

    Time frame: at 3.5 hours after dose administration

    Plasma levels of OBE001

  4. PHARMACOKINETIC-PHARMACODYNAMIC ENDPOINTS :Uterine contractions relationship to OBE001 plasma levels and pregnancy rate

    Time frame: up 10 weeks post OPU day

    Uterine contractions relationship to OBE001 plasma levels and pregnancy rate

Sponsors and collaborators

Lead sponsor

ObsEva SA

Industry

Registry information

Official study title

A Phase 2, Double-blind, Dose-finding, Placebo-controlled Study to Assess the Safety and Efficacy of a Single Oral Administration of OBE001 to Improve Embryo Implantation Following IVF or ICSI

Acronym: IMPLANT

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Dec 8, 2014
Registry last updated
Oct 23, 2017

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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