Study of Nolasiban to Increase Pregnancy Rates in Women Undergoing IVF
IMPLANT4
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
1 other identifier
interventional
820
9 countries
47
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2019
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 28, 2018
CompletedFirst Posted
Study publicly available on registry
November 29, 2018
CompletedStudy Start
First participant enrolled
January 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 21, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 11, 2020
CompletedSeptember 9, 2021
September 1, 2020
11 months
November 28, 2018
September 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Live birth
24 to 40 weeks of gestation
Clinical pregnancy at 6 weeks post ET day
6 weeks post ET
Pregnancy rate at 14 days post Oocyte Pick-up (OPU)
14 days post OPU
Pregnancy loss
6 weeks post ET to 24 weeks gestation
Plasma concentrations of nolasiban
3.5 hours, 5 hours and at 7 hours (latest 72 hours) after nolasiban administration
Other Outcomes (3)
Adverse events
Through study completion, up to 11 months
Neonatal assessments
Birth of infant until 28 days
Ages and Stages Questionnaires® (ASQ-3™) 6 and 12 month Questionnaire
6 and 12 months after term
Study Arms (2)
Nolasiban 900 mg
EXPERIMENTALNolasiban dispersible tablets for single oral administration
Placebo
PLACEBO COMPARATORPlacebo dispersible tablets for single oral administration
Interventions
Eligibility Criteria
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 support with vaginal micronized progesterone.
- Single fresh D5 embryo transfer
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ObsEva SAlead
Study Sites (50)
Site 1001
Brussels, Belgium
Site 1002
Brussels, Belgium
Site 1003
Brussels, Belgium
Site 1004
Brussels, Belgium
Site 1404
Burnaby, Canada
Site 1401
Montreal, Canada
Site 1402
Toronto, Canada
Site 1403
Toronto, Canada
Site 1107
Olomouc, Czechia
Site 1101
Prague, Czechia
Site 1102
Prague, Czechia
Site 1103
Prague, Czechia
Site 1104
Prague, Czechia
Site 1105
Prague, Czechia
Site 1108
Prague, Czechia
Site 1110
Prague, Czechia
Site 1109
Teplice, Czechia
Site 1106
Zlín, Czechia
Site 1204
Copenhagen, Denmark
Site 1205
Herlev, Denmark
Site 1202
Hvidovre, Denmark
Site 1203
Skive, Denmark
Site 1302
Tallinn, Estonia
Site 1301
Tartu, Estonia
Site 1303
Tartu, Estonia
Site 1504
Berlin, Germany
Site 1506
Berlin, Germany
Site 1505
Bielefeld, Germany
Site 1501
Heidelberg, Germany
Site 1502
Lübeck, Germany
Site 1503
Marburg, Germany
Site 1601
Budapest, Hungary
Site 1603
Budapest, Hungary
Site 1602
Tapolca, Hungary
Site 1703
Bialystok, Poland
Site 1705
Bialystok, Poland
Site 1702
Katowice, Poland
Site 1701
Krakow, Poland
Site 1704
Szczecin, Poland
Site 1706
Warsaw, Poland
Site 1901
Moscow, Russia
Site 1905
Moscow, Russia
Site 1904
Samara, Russia
Site 1902
Yekaterinburg, Russia
Site 1805
Barcelona, Spain
Site 1808
Barcelona, Spain
Site 1809
Leioa, Spain
Site 1804
Madrid, Spain
Site 1807
Madrid, Spain
Site 1811
Seville, Spain
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: 33534895DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 28, 2018
First Posted
November 29, 2018
Study Start
January 10, 2019
Primary Completion
November 21, 2019
Study Completion
November 11, 2020
Last Updated
September 9, 2021
Record last verified: 2020-09