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

ObsEva SA247 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

247

Conditions

Infertility

Interventions

OBE001 dose 1DRUG

OBE001 dispersible tablets for single oral administration

OBE001 dose 2DRUG

OBE001 dispersible tablets for single oral administration

OBE001 dose 3DRUG

OBE001 dispersible tablets for single oral administration

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 36 Years

Medical Language ↔ Plain English

Key Inclusion Criteria 1. Women with medically indicated IVF or ICSI using her own oocytes. 2. GnRH antagonist protocol, a single injection of hCG for triggering final follicular maturation and luteal phase support with vaginal micronized progesterone. 3. Evidence of uterine contractions by transvaginal ultrasound at baseline. Key Exclusion Criteria 1. Blastocyst stage or frozen-thaw transfers 2. Clinically significant abnormalities in ECG, vital signs, physical examination or clinical laboratory results 3. Severe endometriosis and/or adenomyosis or risk of ovarian hyper stimulation syndrome

Locations (18)

Unnamed facility

Brussels, Belgium

Unnamed facility

Hradev Kralove, Czechia

Unnamed facility

Olomouc, Czechia

Outcomes

Primary Outcomes

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

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

Time frame: about 6 weeks post ET day

Secondary Outcomes

EFFICACY ENDPOINTS Percentage of women with positive blood pregnancy test

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

Time frame: 14 days post OPU day

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

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

Time frame: 10 weeks post OPU day

EFFICACY ENDPOINTS The embryo-implantation rate

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

Time frame: 6 weeks post ET day

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

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

Time frame: at 3.5 hours after dose administration

Data from ClinicalTrials.gov

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