Study of Nolasiban to Increase Pregnancy Rates in Women Undergoing IVF (IMPLANT4)

ObsEva

Status and phase

Completed

Phase 3

Conditions

Infertility

Treatments

Drug: Placebo

Drug: Nolasiban

Study type

Interventional

Funder types

Industry

Identifiers

NCT03758885

18-OBE001-010

Details and patient eligibility

About

The primary objective of this study is to confirm the efficacy of a single oral 900 mg dose of nolasiban versus placebo to increase the ongoing clinical pregnancy rate at 10 weeks post-embryo transfer (ET) day.

Full description

The study is a prospective, randomised, parallel group, double-blind, placebo-controlled, Phase 3 study to confirm the efficacy and the safety of nolasiban versus placebo to increase pregnancy and live birth rates in 820 women undergoing fresh single blastocyst transfer following in vitro fertilisation (IVF) or intra-cytoplasmic sperm injection (ICSI).

Enrollment

820 patients

Sex

Female

Ages

18 to 37 years old

Volunteers

No Healthy Volunteers

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 support with vaginal micronized progesterone.
Single fresh D5 embryo transfer

Exclusion criteria

Frozen-thawed embryo transfer
Donor egg in the current transfer
More than 20 oocytes in the current controlled ovarian hyperstimulation (COH) cycle
Serum P4 greater than 1.5 ng/mL prior to hCG administration