Phase 3 Placebo Controlled Study of Nolasiban to Improve Pregnancy Rates in Women Undergoing IVF/ICSI

Study Overview
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Brief Summary
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The primary objective of this study is to confirm the efficacy of a single oral 900mg dose of nolasiban to increase the ongoing clinical pregnancy rate at 10 weeks post embryo transfer (ET) day.

Detailed Description
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The study is a prospective, randomized, parallel group, double-blind, placebo-controlled study to confirm the efficacy and the safety of the oxytocin receptor antagonist, nolasiban, in 760 women undergoing fresh embryo transfer following in vitro fertilisation (IVF) or intra-cytoplasmic sperm injection (ICSI).

Official Title
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A Phase 3, Double-blind, Randomized, Placebo-controlled Study to Assess the Efficacy and Safety of a Single Oral Administration of Nolasiban to Improve Pregnancy Rates Following IVF or ICSI in Day 3 and Day 5 Fresh Embryo Transfer Cycles

Conditions
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Infertility

Intervention / Treatment
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* Drug: Nolasiban 900mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Indicated for IVF/ICSI in the context of assisted reproductive technology (ART) Follow a gonadotropin releasing hormone (GnRH) antagonist protocol, single injection of human chorionic gonadotropin (hCG) for triggering final follicular maturation and luteal phase support with vaginal micronized progesterone. Single, fresh D3 or D5 embryo transfer Key Exclusion Criteria: Frozen-thawed embryo transfer More than 20 oocytes in the current controlled ovarian hyperstimulation (COH) cycle Serum P4 greater than 1.5 ng/mL on the day of hCG administration

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

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nolasiban 900 mg<br> | Drug: Nolasiban 900mg<br>* Nolasiban 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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-uterine pregnancy with fetal heart beat at 10 weeks | Intra-uterine pregnancy with fetal heart beat at 10 weeks post embryo transfer day | 10 weeks post ET day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live birth | Live birth after 24 weeks of gestation | Up to 42 weeks of gestation | 
| Miscarriage | Any clinical pregnancy that does not result in a live birth prior 24 weeks | From 6 weeks post ET to 24 weeks gestation | 
| Intra-uterine pregnancy at 6 weeks | Intra-uterine pregnancy with fetal heart beat at 6 weeks post ET day | 6 weeks post ET | 
| Positive blood pregnancy test | Positive blood pregnancy test at 14 days post oocyte pick-up (OPU) | 14 days post OPU | 

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