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

Infertility Clinical Trial

— IMPLANT2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03081208
• Other study ID #: 16-OBE001-005
• Status: Completed
• Phase: Phase 3
• Start date: March 6, 2017
• Est. completion date: February 19, 2019

Study information

• Verified date: December 2019
• 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 900mg dose of nolasiban to increase the ongoing clinical pregnancy rate at 10 weeks post embryo transfer (ET) day.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 810
• Est. completion date: February 19, 2019
• Est. primary completion date: March 21, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 36 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• Nolasiban 900mg
Nolasiban dispersible tablets for single oral administration
• Placebo
Placebo dispersible tablets for single oral administration

Locations

Country	Name	City	State
Belgium	Investigator ID 1001	Brussels
Belgium	Investigator ID 1002	Brussels
Belgium	Investigator ID 1003	Brussels
Belgium	Investigator ID 1004	Brussels
Czechia	Investigator ID 1107	Olomouc
Czechia	Investigator ID 1101	Prague
Czechia	Investigator ID 1102	Prague
Czechia	Investigator ID 1103	Prague
Czechia	Investigator ID 1104	Prague
Czechia	Investigator ID 1108	Prague
Czechia	Investigator ID 1109	Teplice
Czechia	Investigator ID 1106	Zlin
Denmark	Investigator ID 1204	Copenhagen
Denmark	Investigator ID 1205	Herlev
Denmark	Investigator ID 1202	Hvidovre
Denmark	Investigator ID 1203	Skive
Estonia	Investigator ID 1301	Tartu
Estonia	Investigator ID 1303	Tartu
Finland	Investigator ID 1401	Helsinki
Finland	Investigator ID 1402	Helsinki
Finland	Investigator ID 1403	Oulu
Germany	Investigator ID 1501	Heidelberg
Germany	Investigator ID 1502	Lübeck
Germany	Investigator ID 1504	Mainz
Germany	Investigator ID 1503	Marburg
Hungary	Investigator ID 1601	Budapest
Hungary	Investigator ID 1604	Budapest
Hungary	Investigator ID 1603	Pécs
Hungary	Investigator ID 1602	Tapolca
Poland	Investigator ID 1701	Bialystok
Poland	Investigator ID 1703	Bialystok
Poland	Investigator ID 1705	Bialystok
Poland	Investigator ID 1702	Katowice
Poland	Investigator ID 1704	Szczecin
Poland	Investigator ID 1706	Warsaw
Spain	Investigator ID 1801	Barakaldo
Spain	Investigator ID 1805	Barcelona
Spain	Investigator ID 1808	Barcelona
Spain	Investigator ID 1809	Leioa
Spain	Investigator ID 1804	Madrid
Spain	Investigator ID 1807	Madrid
Spain	Investigator ID 1811	Sevilla
Spain	Investigator ID 1806	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
ObsEva SA

Countries where clinical trial is conducted

Belgium,  Czechia,  Denmark,  Estonia,  Finland,  Germany,  Hungary,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events	Frequency and severity of treatment emergent adverse events	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	ASQ-3	Ages and Stages Questionnaire-3 (ASQ-3) domain score(s) at 6 months, adjusted for gestational age at birth	6 months after term
Primary	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	Live birth	Live birth after 24 weeks of gestation	Up to 42 weeks of gestation
Secondary	Miscarriage	Any clinical pregnancy that does not result in a live birth prior 24 weeks	From 6 weeks post ET to 24 weeks gestation
Secondary	Intra-uterine pregnancy at 6 weeks	Intra-uterine pregnancy with fetal heart beat at 6 weeks post ET day	6 weeks post ET
Secondary	Positive blood pregnancy test	Positive blood pregnancy test at 14 days post oocyte pick-up (OPU)	14 days post OPU