Study of Nolasiban to Increase Pregnancy Rates in Women Undergoing IVF

Infertility Clinical Trial

— IMPLANT4  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03758885
• Other study ID #: 18-OBE001-010
• Status: Completed
• Phase: Phase 3
• Start date: January 10, 2019
• Est. completion date: November 11, 2020

Study information

• Verified date: September 2020
• Source: ObsEva SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 820
• Est. completion date: November 11, 2020
• Est. primary completion date: November 21, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 37 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• Nolasiban
Nolasiban single oral administration
• Placebo
Placebo single oral administration

Locations

Country	Name	City	State
Belgium	Site 1002	Brussel
Belgium	Site 1001	Brussels
Belgium	Site 1003	Brussels
Belgium	Site 1004	Brussels
Canada	Site 1404	Burnaby
Canada	Site 1401	Montréal
Canada	Site 1402	Toronto
Canada	Site 1403	Toronto
Czechia	Site 1107	Olomouc
Czechia	Site 1101	Praha
Czechia	Site 1102	Praha
Czechia	Site 1103	Praha
Czechia	Site 1104	Praha
Czechia	Site 1105	Praha
Czechia	Site 1108	Praha
Czechia	Site 1110	Praha
Czechia	Site 1109	Teplice
Czechia	Site 1106	Zlín
Denmark	Site 1205	Herlev
Denmark	Site 1202	Hvidovre
Denmark	Site 1204	Kobenhavn
Denmark	Site 1203	Skive
Estonia	Site 1302	Tallinn
Estonia	Site 1301	Tartu
Estonia	Site 1303	Tartu
Germany	Site 1504	Berlin
Germany	Site 1506	Berlin
Germany	Site 1505	Bielefeld
Germany	Site 1501	Heidelberg
Germany	Site 1502	Lubeck
Germany	Site 1503	Marburg
Hungary	Site 1601	Budapest
Hungary	Site 1603	Budapest
Hungary	Site 1602	Tapolca
Poland	Site 1703	Bialystok
Poland	Site 1705	Bialystok
Poland	Site 1702	Katowice
Poland	Site 1701	Kraków
Poland	Site 1704	Szczecin
Poland	Site 1706	Warsaw
Russian Federation	Site 1902	Ekaterinburg
Russian Federation	Site 1901	Moscow
Russian Federation	Site 1905	Moscow
Russian Federation	Site 1904	Samara
Spain	Site 1805	Barcelona
Spain	Site 1808	Barcelona
Spain	Site 1809	Leioa
Spain	Site 1804	Madrid
Spain	Site 1807	Madrid
Spain	Site 1811	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
ObsEva SA

Countries where clinical trial is conducted

Belgium,  Canada,  Czechia,  Denmark,  Estonia,  Germany,  Hungary,  Poland,  Russian Federation,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events	Treatment emergent adverse events frequency and severity	Through study completion, up to 11 months
Other	Neonatal assessments	Incidence of any malformation or any significant morbidity during the neonatal period	Birth of infant until 28 days
Other	Ages and Stages Questionnaires® (ASQ-3™) 6 and 12 month Questionnaire	Screening questionnaire composed of 30 questions completed by the parent. Questions are divided into five areas: communication, gross motor, fine motor, problem solving and personal-social. Parents respond yes, sometimes and not yet to questions, these are converted to points 10, 5 and 0 for scoring and are totalled for each developmental area. These 5 area scores are compared with empirically derived cutoff points.	6 and 12 months after term
Primary	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	Live birth	Live birth after 24 weeks of gestation	24 to 40 weeks of gestation
Secondary	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
Secondary	Pregnancy rate at 14 days post Oocyte Pick-up (OPU)	Positive blood pregnancy test at 14 days post OPU day	14 days post OPU
Secondary	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
Secondary	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