CompletedPhase 2

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

Belgium, Czechia247 participantsStarted 2014-11

Plain-language 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.

Who can participate

Age range18 Years – 36 Years

SexFEMALE

See this in plain English?

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

Inclusion criteria

✓. Women with medically indicated IVF or ICSI using her own oocytes.
✓. GnRH antagonist protocol, a single injection of hCG for triggering final follicular maturation and luteal phase support with vaginal micronized progesterone.
✓. Evidence of uterine contractions by transvaginal ultrasound at baseline.

Exclusion criteria

✕. Blastocyst stage or frozen-thaw transfers
✕. Clinically significant abnormalities in ECG, vital signs, physical examination or clinical laboratory results
✕. Severe endometriosis and/or adenomyosis or risk of ovarian hyper stimulation syndrome

What they're measuring

EFFICACY ENDPOINTS Percentage of women with an intra-uterine pregnancy with positive embryo heart-beat

Timeframe: about 6 weeks post ET day

Trial details

NCT IDNCT02310802

SponsorObsEva SA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-11

View on ClinicalTrials.gov More Infertility trials