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

ObsEva

Status and phase: Completed; Phase 2

Conditions: Infertility

Treatments: Drug: Placebo; Drug: OBE001 dose 1; Drug: OBE001 dose 3; Drug: OBE001 dose 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT02310802

14-OBE001-013

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 247 patients

Sex: Female

Ages: 18 to 36 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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247 participants in 4 patient groups, including a placebo group

OBE001 dose 1

Experimental group

Treatment:

Drug: OBE001 dose 1

OBE001 dose 2

Experimental group

Treatment:

Drug: OBE001 dose 2

OBE001 dose 3

Experimental group

Treatment:

Drug: OBE001 dose 3

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo