CompletedPhase 3

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

Belgium, Czechia810 participantsStarted 2017-03-06

Plain-language 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.

Who can participate

Age range18 Years – 36 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Intra-uterine pregnancy with fetal heart beat at 10 weeks

Timeframe: 10 weeks post ET day

Trial details

NCT IDNCT03081208

SponsorObsEva SA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-03-21

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