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

Study Overview
=================
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.

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

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Drug: OBE001 dose 1
* Drug: OBE001 dose 2
* Drug: OBE001 dose 3
* Drug: Placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 36 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OBE001 dose 1<br> | Drug: OBE001 dose 1<br>* OBE001 dispersible tablets for single oral administration<br>|
| Experimental: OBE001 dose 2<br> | Drug: OBE001 dose 2<br>* OBE001 dispersible tablets for single oral administration<br>|
| Experimental: OBE001 dose 3<br> | Drug: OBE001 dose 3<br>* OBE001 dispersible tablets for single oral administration<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo dispersible tablets for single oral administration<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | about 6 weeks post ET day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EFFICACY ENDPOINTS Percentage of women with positive blood pregnancy test | Percentage of women with positive blood pregnancy test at 14 days post OPU day. | 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. | 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 | 6 weeks post ET day | 
| 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). | at 3.5 hours after dose administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IVF, ICSI