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Study of Nolasiban to Increase Pregnancy Rates in Women Undergoing IVF (IMPLANT4)

Primary Purpose

Infertility

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Nolasiban
Placebo
Sponsored by
ObsEva SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring IVF, ICSI, ART, ET

Eligibility Criteria

18 Years - 37 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Site 1001
  • Site 1003
  • Site 1004
  • Site 1002
  • Site 1404
  • Site 1401
  • Site 1402
  • Site 1403
  • Site 1107
  • Site 1101
  • Site 1102
  • Site 1103
  • Site 1104
  • Site 1105
  • Site 1108
  • Site 1110
  • Site 1109
  • Site 1106
  • Site 1205
  • Site 1202
  • Site 1204
  • Site 1203
  • Site 1302
  • Site 1301
  • Site 1303
  • Site 1504
  • Site 1506
  • Site 1505
  • Site 1501
  • Site 1502
  • Site 1503
  • Site 1601
  • Site 1603
  • Site 1602
  • Site 1703
  • Site 1705
  • Site 1702
  • Site 1701
  • Site 1704
  • Site 1706
  • Site 1902
  • Site 1901
  • Site 1905
  • Site 1904
  • Site 1805
  • Site 1808
  • Site 1809
  • Site 1804
  • Site 1807
  • Site 1811

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nolasiban 900 mg

Placebo

Arm Description

Nolasiban dispersible tablets for single oral administration

Placebo dispersible tablets for single oral administration

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Live birth
Live birth after 24 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
Pregnancy rate at 14 days post Oocyte Pick-up (OPU)
Positive blood pregnancy test at 14 days post OPU day
Pregnancy loss
Pregnancy loss at 6 or 10 weeks after ET and before 24 weeks of gestation
Plasma concentrations of nolasiban
Plasma concentrations of nolasiban after administration

Full Information

First Posted
November 28, 2018
Last Updated
September 8, 2021
Sponsor
ObsEva SA
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1. Study Identification

Unique Protocol Identification Number
NCT03758885
Brief Title
Study of Nolasiban to Increase Pregnancy Rates in Women Undergoing IVF
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
January 10, 2019 (Actual)
Primary Completion Date
November 21, 2019 (Actual)
Study Completion Date
November 11, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ObsEva SA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
IVF, ICSI, ART, ET

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
820 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nolasiban 900 mg
Arm Type
Experimental
Arm Description
Nolasiban dispersible tablets for single oral administration
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo dispersible tablets for single oral administration
Intervention Type
Drug
Intervention Name(s)
Nolasiban
Intervention Description
Nolasiban single oral administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo single oral administration
Primary Outcome Measure Information:
Title
Ongoing pregnancy with fetal heart beat at 10 weeks
Description
Ongoing pregnancy defined as an intra-uterine pregnancy with fetal heart beat at 10 weeks post embryo transfer day
Time Frame
10 weeks post ET day
Secondary Outcome Measure Information:
Title
Live birth
Description
Live birth after 24 weeks of gestation
Time Frame
24 to 40 weeks of gestation
Title
Clinical pregnancy at 6 weeks post ET day
Description
Clinical pregnancy defined as intra-uterine pregnancy with fetal heart beat at 6 weeks post-ET day
Time Frame
6 weeks post ET
Title
Pregnancy rate at 14 days post Oocyte Pick-up (OPU)
Description
Positive blood pregnancy test at 14 days post OPU day
Time Frame
14 days post OPU
Title
Pregnancy loss
Description
Pregnancy loss at 6 or 10 weeks after ET and before 24 weeks of gestation
Time Frame
6 weeks post ET to 24 weeks gestation
Title
Plasma concentrations of nolasiban
Description
Plasma concentrations of nolasiban after administration
Time Frame
3.5 hours, 5 hours and at 7 hours (latest 72 hours) after nolasiban administration
Other Pre-specified Outcome Measures:
Title
Adverse events
Description
Treatment emergent adverse events frequency and severity
Time Frame
Through study completion, up to 11 months
Title
Neonatal assessments
Description
Incidence of any malformation or any significant morbidity during the neonatal period
Time Frame
Birth of infant until 28 days
Title
Ages and Stages Questionnaires® (ASQ-3™) 6 and 12 month Questionnaire
Description
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.
Time Frame
6 and 12 months after term

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
37 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Site 1001
City
Brussels
Country
Belgium
Facility Name
Site 1003
City
Brussels
Country
Belgium
Facility Name
Site 1004
City
Brussels
Country
Belgium
Facility Name
Site 1002
City
Brussel
Country
Belgium
Facility Name
Site 1404
City
Burnaby
Country
Canada
Facility Name
Site 1401
City
Montréal
Country
Canada
Facility Name
Site 1402
City
Toronto
Country
Canada
Facility Name
Site 1403
City
Toronto
Country
Canada
Facility Name
Site 1107
City
Olomouc
Country
Czechia
Facility Name
Site 1101
City
Praha
Country
Czechia
Facility Name
Site 1102
City
Praha
Country
Czechia
Facility Name
Site 1103
City
Praha
Country
Czechia
Facility Name
Site 1104
City
Praha
Country
Czechia
Facility Name
Site 1105
City
Praha
Country
Czechia
Facility Name
Site 1108
City
Praha
Country
Czechia
Facility Name
Site 1110
City
Praha
Country
Czechia
Facility Name
Site 1109
City
Teplice
Country
Czechia
Facility Name
Site 1106
City
Zlín
Country
Czechia
Facility Name
Site 1205
City
Herlev
Country
Denmark
Facility Name
Site 1202
City
Hvidovre
Country
Denmark
Facility Name
Site 1204
City
Kobenhavn
Country
Denmark
Facility Name
Site 1203
City
Skive
Country
Denmark
Facility Name
Site 1302
City
Tallinn
Country
Estonia
Facility Name
Site 1301
City
Tartu
Country
Estonia
Facility Name
Site 1303
City
Tartu
Country
Estonia
Facility Name
Site 1504
City
Berlin
Country
Germany
Facility Name
Site 1506
City
Berlin
Country
Germany
Facility Name
Site 1505
City
Bielefeld
Country
Germany
Facility Name
Site 1501
City
Heidelberg
Country
Germany
Facility Name
Site 1502
City
Lubeck
Country
Germany
Facility Name
Site 1503
City
Marburg
Country
Germany
Facility Name
Site 1601
City
Budapest
Country
Hungary
Facility Name
Site 1603
City
Budapest
Country
Hungary
Facility Name
Site 1602
City
Tapolca
Country
Hungary
Facility Name
Site 1703
City
Białystok
Country
Poland
Facility Name
Site 1705
City
Białystok
Country
Poland
Facility Name
Site 1702
City
Katowice
Country
Poland
Facility Name
Site 1701
City
Kraków
Country
Poland
Facility Name
Site 1704
City
Szczecin
Country
Poland
Facility Name
Site 1706
City
Warsaw
Country
Poland
Facility Name
Site 1902
City
Ekaterinburg
Country
Russian Federation
Facility Name
Site 1901
City
Moscow
Country
Russian Federation
Facility Name
Site 1905
City
Moscow
Country
Russian Federation
Facility Name
Site 1904
City
Samara
Country
Russian Federation
Facility Name
Site 1805
City
Barcelona
Country
Spain
Facility Name
Site 1808
City
Barcelona
Country
Spain
Facility Name
Site 1809
City
Leioa
Country
Spain
Facility Name
Site 1804
City
Madrid
Country
Spain
Facility Name
Site 1807
City
Madrid
Country
Spain
Facility Name
Site 1811
City
Sevilla
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
33534895
Citation
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.
Results Reference
derived

Learn more about this trial

Study of Nolasiban to Increase Pregnancy Rates in Women Undergoing IVF

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