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

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ObsEva SA

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