Overview

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