Clincosm LogoSign in Get a demo

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

Sponsor
ObsEva SA (Industry)
Overall Status
Completed
CT.gov ID
NCT02310802
Collaborator
(none)
247
Enrollment
18
Locations
4
Arms
25
Duration (Months)
13.7
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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 placebo.

Condition or Disease Intervention/Treatment Phase
  • Drug: OBE001 dose 1
  • Drug: OBE001 dose 2
  • Drug: OBE001 dose 3
  • Drug: Placebo
 Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
247 participants
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
Study Start Date :
Nov 1, 2014
Actual Primary Completion Date :
Nov 1, 2015
Actual Study Completion Date :
Dec 1, 2016

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

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

  1. EFFICACY ENDPOINTS Percentage of women with positive blood pregnancy test [14 days post OPU day]

    Percentage of women with positive blood pregnancy test at 14 days post OPU day.

  2. EFFICACY ENDPOINTS Percentage of women with an intra-uterine pregnancy with positive embryo heart-beat [10 weeks post OPU day]

    Percentage of women with an intra-uterine pregnancy with positive embryo heart-beat at 10 weeks post OPU day.

  3. EFFICACY ENDPOINTS The embryo-implantation rate [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

  4. EFFICACY ENDPOINTS Change from baseline to the time of ET in the rate of uterine contractions [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

  1. SAFETY ENDPOINTS Treatment emergent adverse events frequency and severity [up to 10 weeks post OPU day]

    Treatment emergent adverse events frequency and severity

  2. SAFETY ENDPOINTS (Haematology and biochemistry assessments) [14 days post OPU day]

    Haematology and biochemistry assessments at screening and at visit V3 (14 days post OPU day)

  3. PHARMACOKINETIC ENDPOINTS Plasma levels of OBE001 [at 3.5 hours after dose administration]

    Plasma levels of OBE001

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

    Uterine contractions relationship to OBE001 plasma levels and pregnancy rate

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 36 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No

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

Locations

Site City State Country Postal Code
1 Brussels Belgium
2 Hradev Kralove Czechia
3 Olomouc Czechia
4 Prague Czechia
5 Zlin Czechia
6 Copenhagen Denmark
7 Hvidovre Denmark
8 Bialystok Poland
9 Katowice Poland
10 Szczecin Poland
11 Warsaw Poland
12 Alicante Spain
13 Barakaldo Spain
14 Barcelona Spain
15 Bilbao Spain
16 Sevilla Spain
17 Vigo Spain
18 London United Kingdom

Sponsors and Collaborators

  • ObsEva SA

Investigators

  • Study Director: Clinical Study Director, ObsEva SA

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ObsEva SA
ClinicalTrials.gov Identifier:
NCT02310802
Other Study ID Numbers:
  • 14-OBE001-013
First Posted:
Dec 8, 2014
Last Update Posted:
Oct 23, 2017
Last Verified:
Oct 1, 2017
Keywords provided by ObsEva SA
IVF
ICSI
Additional relevant MeSH terms:
Infertility

Study Results

No Results Posted as of Oct 23, 2017