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

Primary Purpose

Infertility

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
OBE001 dose 1
OBE001 dose 2
OBE001 dose 3
Placebo
Sponsored by
ObsEva SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring IVF, ICSI

Eligibility Criteria

18 Years - 36 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

OBE001 dose 1

OBE001 dose 2

OBE001 dose 3

Placebo

Arm Description

Outcomes

Primary Outcome Measures

EFFICACY ENDPOINTS Percentage of women with an intra-uterine pregnancy with positive embryo heart-beat
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
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
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
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
Change from baseline to the time of ET in the rate of uterine contractions (UC/min).

Full Information

First Posted
November 19, 2014
Last Updated
October 20, 2017
Sponsor
ObsEva SA
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1. Study Identification

Unique Protocol Identification Number
NCT02310802
Brief Title
OBE001 Phase 2 Dose-finding Study Versus Placebo in Women Undergoing Embryo Transfer in the Context of IVF-ICSI
Acronym
IMPLANT
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 Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ObsEva SA

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
IVF, ICSI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
247 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OBE001 dose 1
Arm Type
Experimental
Arm Title
OBE001 dose 2
Arm Type
Experimental
Arm Title
OBE001 dose 3
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
OBE001 dose 1
Intervention Description
OBE001 dispersible tablets for single oral administration
Intervention Type
Drug
Intervention Name(s)
OBE001 dose 2
Intervention Description
OBE001 dispersible tablets for single oral administration
Intervention Type
Drug
Intervention Name(s)
OBE001 dose 3
Intervention Description
OBE001 dispersible tablets for single oral administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo dispersible tablets for single oral administration
Primary Outcome Measure Information:
Title
EFFICACY ENDPOINTS Percentage of women with an intra-uterine pregnancy with positive embryo heart-beat
Description
Percentage of women with an intra-uterine pregnancy with positive embryo heart-beat at about 6 weeks post ET day.
Time Frame
about 6 weeks post ET day
Secondary Outcome Measure Information:
Title
EFFICACY ENDPOINTS Percentage of women with positive blood pregnancy test
Description
Percentage of women with positive blood pregnancy test at 14 days post OPU day.
Time Frame
14 days post OPU day
Title
EFFICACY ENDPOINTS Percentage of women with an intra-uterine pregnancy with positive embryo heart-beat
Description
Percentage of women with an intra-uterine pregnancy with positive embryo heart-beat at 10 weeks post OPU day.
Time Frame
10 weeks post OPU day
Title
EFFICACY ENDPOINTS The embryo-implantation rate
Description
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
Time Frame
6 weeks post ET day
Title
EFFICACY ENDPOINTS Change from baseline to the time of ET in the rate of uterine contractions
Description
Change from baseline to the time of ET in the rate of uterine contractions (UC/min).
Time Frame
at 3.5 hours after dose administration
Other Pre-specified Outcome Measures:
Title
SAFETY ENDPOINTS Treatment emergent adverse events frequency and severity
Description
Treatment emergent adverse events frequency and severity
Time Frame
up to 10 weeks post OPU day
Title
SAFETY ENDPOINTS (Haematology and biochemistry assessments)
Description
Haematology and biochemistry assessments at screening and at visit V3 (14 days post OPU day)
Time Frame
14 days post OPU day
Title
PHARMACOKINETIC ENDPOINTS Plasma levels of OBE001
Description
Plasma levels of OBE001
Time Frame
at 3.5 hours after dose administration
Title
PHARMACOKINETIC-PHARMACODYNAMIC ENDPOINTS :Uterine contractions relationship to OBE001 plasma levels and pregnancy rate
Description
Uterine contractions relationship to OBE001 plasma levels and pregnancy rate
Time Frame
up 10 weeks post OPU day

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
36 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Study Director
Organizational Affiliation
ObsEva SA
Official's Role
Study Director
Facility Information:
City
Brussels
Country
Belgium
City
Hradev Kralove
Country
Czechia
City
Olomouc
Country
Czechia
City
Prague
Country
Czechia
City
Zlin
Country
Czechia
City
Copenhagen
Country
Denmark
City
Hvidovre
Country
Denmark
City
Bialystok
Country
Poland
City
Katowice
Country
Poland
City
Szczecin
Country
Poland
City
Warsaw
Country
Poland
City
Alicante
Country
Spain
City
Barakaldo
Country
Spain
City
Barcelona
Country
Spain
City
Bilbao
Country
Spain
City
Sevilla
Country
Spain
City
Vigo
Country
Spain
City
London
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
33534895
Citation
Griesinger G, Blockeel C, Pierzynski P, Tournaye H, Visnova H, Humberstone A, Terrill P, Pohl O, Garner E, Donnez J, Loumaye E. Effect of the oxytocin receptor antagonist nolasiban on pregnancy rates in women undergoing embryo transfer following IVF: analysis of three randomised clinical trials. Hum Reprod. 2021 Mar 18;36(4):1007-1020. doi: 10.1093/humrep/deaa369.
Results Reference
derived

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

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