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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02310802
First Posted: December 8, 2014
Last Update Posted: October 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
ObsEva SA
  Purpose
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.

Condition Intervention Phase
Infertility Drug: OBE001 dose 1 Drug: OBE001 dose 2 Drug: OBE001 dose 3 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Double-blind, Dose-finding, Placebo-controlled Study to Assess the Safety and Efficacy of a Single Oral Administration of OBE001 to Improve Embryo Implantation Following IVF or ICSI

Further study details as provided by ObsEva SA:

Primary Outcome Measures:
  • EFFICACY ENDPOINTS Percentage of women with an intra-uterine pregnancy with positive embryo heart-beat [ Time Frame: about 6 weeks post ET day ]
    Percentage of women with an intra-uterine pregnancy with positive embryo heart-beat at about 6 weeks post ET day.


Secondary Outcome Measures:
  • EFFICACY ENDPOINTS Percentage of women with positive blood pregnancy test [ Time Frame: 14 days post OPU day ]
    Percentage of women with positive blood pregnancy test at 14 days post OPU day.

  • EFFICACY ENDPOINTS Percentage of women with an intra-uterine pregnancy with positive embryo heart-beat [ Time Frame: 10 weeks post OPU day ]
    Percentage of women with an intra-uterine pregnancy with positive embryo heart-beat at 10 weeks post OPU day.

  • EFFICACY ENDPOINTS The embryo-implantation rate [ Time Frame: 6 weeks post ET day ]
    The embryo-implantation rate defined as the number of intra-uterine embryos with positive heart-beat at 6 weeks post ET day divided by the number of embryos transferred

  • EFFICACY ENDPOINTS Change from baseline to the time of ET in the rate of uterine contractions [ Time Frame: at 3.5 hours after dose administration ]
    Change from baseline to the time of ET in the rate of uterine contractions (UC/min).


Other Outcome Measures:
  • SAFETY ENDPOINTS Treatment emergent adverse events frequency and severity [ Time Frame: up to 10 weeks post OPU day ]
    Treatment emergent adverse events frequency and severity

  • SAFETY ENDPOINTS (Haematology and biochemistry assessments) [ Time Frame: 14 days post OPU day ]
    Haematology and biochemistry assessments at screening and at visit V3 (14 days post OPU day)

  • PHARMACOKINETIC ENDPOINTS Plasma levels of OBE001 [ Time Frame: at 3.5 hours after dose administration ]
    Plasma levels of OBE001

  • PHARMACOKINETIC-PHARMACODYNAMIC ENDPOINTS :Uterine contractions relationship to OBE001 plasma levels and pregnancy rate [ Time Frame: up 10 weeks post OPU day ]
    Uterine contractions relationship to OBE001 plasma levels and pregnancy rate


Enrollment: 247
Study Start Date: November 2014
Study Completion Date: December 2016
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OBE001 dose 1 Drug: OBE001 dose 1
OBE001 dispersible tablets for single oral administration
Experimental: OBE001 dose 2 Drug: OBE001 dose 2
OBE001 dispersible tablets for single oral administration
Experimental: OBE001 dose 3 Drug: OBE001 dose 3
OBE001 dispersible tablets for single oral administration
Placebo Comparator: Placebo Drug: Placebo
Placebo dispersible tablets for single oral administration

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 women undergoing embryo transfer following IVF or ICSI.

The four-arm study (OBE001 dose 1, dose 2, dose 3, and placebo) design will allow evaluation of a possible dose-dependent pattern of action of OBE001 and, simultaneously, comparison of active compound with placebo with regard to both efficacy and safety.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 36 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria

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

Key Exclusion Criteria

  1. Blastocyst stage or frozen-thaw transfers
  2. Clinically significant abnormalities in ECG, vital signs, physical examination or clinical laboratory results
  3. Severe endometriosis and/or adenomyosis or risk of ovarian hyper stimulation syndrome
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02310802


Locations
Belgium
Brussels, Belgium
Czechia
Hradev Kralove, Czechia
Olomouc, Czechia
Prague, Czechia
Zlin, Czechia
Denmark
Copenhagen, Denmark
Hvidovre, Denmark
Poland
Bialystok, Poland
Katowice, Poland
Szczecin, Poland
Warsaw, Poland
Spain
Alicante, Spain
Barakaldo, Spain
Barcelona, Spain
Bilbao, Spain
Sevilla, Spain
Vigo, Spain
United Kingdom
London, United Kingdom
Sponsors and Collaborators
ObsEva SA
Investigators
Study Director: Clinical Study Director ObsEva SA
  More Information

Responsible Party: ObsEva SA
ClinicalTrials.gov Identifier: NCT02310802     History of Changes
Other Study ID Numbers: 14-OBE001-013
First Submitted: November 19, 2014
First Posted: December 8, 2014
Last Update Posted: October 23, 2017
Last Verified: October 2017

Keywords provided by ObsEva SA:
IVF
ICSI

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female