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

NCT03081208 | Completed Phase 3

• 1 other identifier: 16-OBE001-005
• Study Type: interventional
• Target: 810
• Locations: 8 countries
• Sites: 35

Brief 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.

Conditions

Infertility

Keywords

IVF; ICSI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Live birth

  Up to 42 weeks of gestation

• Miscarriage

  From 6 weeks post ET to 24 weeks gestation

• Intra-uterine pregnancy at 6 weeks

  6 weeks post ET

• Positive blood pregnancy test

  14 days post OPU

Other Outcomes (3)

• Adverse events

  Through study completion, up to 11 months

• Neonatal assessments

  Birth of infant until 28 days

• ASQ-3

  6 months after term

Study Arms (2)

Nolasiban 900 mg

EXPERIMENTAL

Drug: Nolasiban 900mg

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Nolasiban 900mg DRUG

Nolasiban dispersible tablets for single oral administration

Nolasiban 900 mg

Placebo DRUG

Placebo dispersible tablets for single oral administration

Placebo

Eligibility Criteria

• Age: 18 Years - 36 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ObsEva SA: lead

Study Sites (43)

Investigator ID 1001

Brussels, Belgium

Location

Investigator ID 1002

Brussels, Belgium

Location

Investigator ID 1003

Brussels, Belgium

Location

Investigator ID 1004

Brussels, Belgium

Location

Investigator ID 1107

Olomouc, Czechia

Location

Investigator ID 1101

Prague, Czechia

Location

Investigator ID 1102

Prague, Czechia

Location

Investigator ID 1103

Prague, Czechia

Location

Investigator ID 1104

Prague, Czechia

Location

Investigator ID 1108

Prague, Czechia

Location

Investigator ID 1109

Teplice, Czechia

Location

Investigator ID 1106

Zlín, Czechia

Location

Investigator ID 1204

Copenhagen, Denmark

Location

Investigator ID 1205

Herlev, Denmark

Location

Investigator ID 1202

Hvidovre, Denmark

Location

Investigator ID 1203

Skive, Denmark

Location

Investigator ID 1301

Tartu, Estonia

Location

Investigator ID 1303

Tartu, Estonia

Location

Investigator ID 1401

Helsinki, Finland

Location

Investigator ID 1402

Helsinki, Finland

Location

Investigator ID 1403

Oulu, Finland

Location

Investigator ID 1501

Heidelberg, Germany

Location

Investigator ID 1502

Lübeck, Germany

Location

Investigator ID 1504

Mainz, Germany

Location

Investigator ID 1503

Marburg, Germany

Location

Investigator ID 1601

Budapest, Hungary

Location

Investigator ID 1604

Budapest, Hungary

Location

Investigator ID 1603

Pécs, Hungary

Location

Investigator ID 1602

Tapolca, Hungary

Location

Investigator ID 1701

Bialystok, Poland

Location

Investigator ID 1703

Bialystok, Poland

Location

Investigator ID 1705

Bialystok, Poland

Location

Investigator ID 1702

Katowice, Poland

Location

Investigator ID 1704

Szczecin, Poland

Location

Investigator ID 1706

Warsaw, Poland

Location

Investigator ID 1801

Barakaldo, Spain

Location

Investigator ID 1805

Barcelona, Spain

Location

Investigator ID 1808

Barcelona, Spain

Location

Investigator ID 1809

Leioa, Spain

Location

Investigator ID 1804

Madrid, Spain

Location

Investigator ID 1807

Madrid, Spain

Location

Investigator ID 1811

Seville, Spain

Location

Investigator ID 1806

Valencia, Spain

Location

Related Publications (1)

• Griesinger G, Blockeel C, Pierzynski P, Tournaye H, Visnova H, Humberstone A, Terrill P, Pohl O, Garner E, Donnez J, Loumaye E. Effect of the oxytocin receptor antagonist nolasiban on pregnancy rates in women undergoing embryo transfer following IVF: analysis of three randomised clinical trials. Hum Reprod. 2021 Mar 18;36(4):1007-1020. doi: 10.1093/humrep/deaa369.

  PMID: 33534895 DERIVED

MeSH Terms

Conditions

Infertility

Interventions

nolasiban

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• ObsEva SA

  Geneva

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2017
• First Posted: March 16, 2017
• Study Start: March 6, 2017
• Primary Completion: March 21, 2018
• Study Completion: February 19, 2019
• Last Updated: December 23, 2019

Record last verified: 2019-12

Locations

DK (4); FI (3); DE (4); HU (4); BE (4); CZ (8); PL (6); ES (2)