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

• Status: Completed
• Trial end date: 2019-02-19
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ObsEva SA

Criteria

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