Study of Nolasiban to Increase Pregnancy Rates in Women Undergoing IVF

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 900 mg dose of nolasiban versus placebo 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, randomised, parallel group, double-blind, placebo-controlled, Phase 3 study to confirm the efficacy and the safety of nolasiban versus placebo to increase pregnancy and live birth rates in 820 women undergoing fresh single blastocyst 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 Safety and Efficacy of a Single Oral Administration of Nolasiban to Increase On-going Pregnancy Rate Following Fresh Single Blastocyst Transfer Resulting From IVF

Conditions
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Infertility

Intervention / Treatment
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* Drug: Nolasiban
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 support with vaginal micronized progesterone. Single fresh D5 embryo transfer Exclusion Criteria: Frozen-thawed embryo transfer Donor egg in the current transfer More than 20 oocytes in the current controlled ovarian hyperstimulation (COH) cycle Serum P4 greater than 1.5 ng/mL prior to hCG administration

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 37 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>Nolasiban dispersible tablets for single oral administration | Drug: Nolasiban<br>* Nolasiban single oral administration<br>|
| Placebo Comparator: Placebo<br>Placebo dispersible tablets for single oral administration | Drug: Placebo<br>* Placebo single oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing pregnancy with fetal heart beat at 10 weeks | Ongoing pregnancy defined as an 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 | 24 to 40 weeks of gestation | 
| Clinical pregnancy at 6 weeks post ET day | Clinical pregnancy defined as intra-uterine pregnancy with fetal heart beat at 6 weeks post-ET day | 6 weeks post ET | 
| Pregnancy rate at 14 days post Oocyte Pick-up (OPU) | Positive blood pregnancy test at 14 days post OPU day | 14 days post OPU | 
| Pregnancy loss | Pregnancy loss at 6 or 10 weeks after ET and before 24 weeks of gestation | 6 weeks post ET to 24 weeks gestation | 
| Plasma concentrations of nolasiban | Plasma concentrations of nolasiban after administration | 3.5 hours, 5 hours and at 7 hours (latest 72 hours) after nolasiban administration | 

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