Status:
COMPLETED
OBE001 Phase 2 Dose-finding Study Versus Placebo in Women Undergoing Embryo Transfer in the Context of IVF-ICSI
Lead Sponsor:
ObsEva SA
Conditions:
Infertility
Eligibility:
FEMALE
18-36 years
Phase:
PHASE2
Brief 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 placeb...
Detailed Description
The study is a prospective, dose-finding, randomised, parallel group, double-blind, placebo-controlled study investigating the efficacy and the safety of the oxytocin receptor antagonist OBE001 in 240...
Eligibility Criteria
Inclusion
- Key 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.
- Key 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
Exclusion
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
247 Patients enrolled
Trial Details
Trial ID
NCT02310802
Start Date
November 1 2014
End Date
December 1 2016
Last Update
October 23 2017
Active Locations (18)
Enter a location and click search to find clinical trials sorted by distance.
1
Brussels, Belgium
2
Hradev Kralove, Czechia
3
Olomouc, Czechia
4
Prague, Czechia