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Phase 3 Placebo Controlled Study of Nolasiban to Improve Pregnancy Rates in Women Undergoing IVF/ICSI (IMPLANT2)

Primary Purpose

Infertility

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Nolasiban 900mg
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

Eligibility Criteria

18 Years - 36 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Investigator ID 1001
  • Investigator ID 1002
  • Investigator ID 1003
  • Investigator ID 1004
  • Investigator ID 1107
  • Investigator ID 1101
  • Investigator ID 1102
  • Investigator ID 1103
  • Investigator ID 1104
  • Investigator ID 1108
  • Investigator ID 1109
  • Investigator ID 1106
  • Investigator ID 1204
  • Investigator ID 1205
  • Investigator ID 1202
  • Investigator ID 1203
  • Investigator ID 1301
  • Investigator ID 1303
  • Investigator ID 1401
  • Investigator ID 1402
  • Investigator ID 1403
  • Investigator ID 1501
  • Investigator ID 1502
  • Investigator ID 1504
  • Investigator ID 1503
  • Investigator ID 1601
  • Investigator ID 1604
  • Investigator ID 1603
  • Investigator ID 1602
  • Investigator ID 1701
  • Investigator ID 1703
  • Investigator ID 1705
  • Investigator ID 1702
  • Investigator ID 1704
  • Investigator ID 1706
  • Investigator ID 1801
  • Investigator ID 1805
  • Investigator ID 1808
  • Investigator ID 1809
  • Investigator ID 1804
  • Investigator ID 1807
  • Investigator ID 1811
  • Investigator ID 1806

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nolasiban 900 mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Intra-uterine pregnancy with fetal heart beat at 10 weeks
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
Miscarriage
Any clinical pregnancy that does not result in a live birth prior 24 weeks
Intra-uterine pregnancy at 6 weeks
Intra-uterine pregnancy with fetal heart beat at 6 weeks post ET day
Positive blood pregnancy test
Positive blood pregnancy test at 14 days post oocyte pick-up (OPU)

Full Information

First Posted
March 6, 2017
Last Updated
December 20, 2019
Sponsor
ObsEva SA
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1. Study Identification

Unique Protocol Identification Number
NCT03081208
Brief Title
Phase 3 Placebo Controlled Study of Nolasiban to Improve Pregnancy Rates in Women Undergoing IVF/ICSI
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
March 6, 2017 (Actual)
Primary Completion Date
March 21, 2018 (Actual)
Study Completion Date
February 19, 2019 (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 900mg dose of nolasiban to increase the ongoing clinical pregnancy rate at 10 weeks post embryo transfer (ET) day.
Detailed 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).

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Nolasiban 900 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Nolasiban 900mg
Intervention Description
Nolasiban dispersible tablets for single oral administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo dispersible tablets for single oral administration
Primary Outcome Measure Information:
Title
Intra-uterine pregnancy with fetal heart beat at 10 weeks
Description
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
Up to 42 weeks of gestation
Title
Miscarriage
Description
Any clinical pregnancy that does not result in a live birth prior 24 weeks
Time Frame
From 6 weeks post ET to 24 weeks gestation
Title
Intra-uterine pregnancy at 6 weeks
Description
Intra-uterine pregnancy with fetal heart beat at 6 weeks post ET day
Time Frame
6 weeks post ET
Title
Positive blood pregnancy test
Description
Positive blood pregnancy test at 14 days post oocyte pick-up (OPU)
Time Frame
14 days post OPU
Other Pre-specified Outcome Measures:
Title
Adverse events
Description
Frequency and severity of treatment emergent adverse events
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
ASQ-3
Description
Ages and Stages Questionnaire-3 (ASQ-3) domain score(s) at 6 months, adjusted for gestational age at birth
Time Frame
6 months after term

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
36 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ObsEva SA
Organizational Affiliation
Geneva
Official's Role
Study Director
Facility Information:
Facility Name
Investigator ID 1001
City
Brussels
Country
Belgium
Facility Name
Investigator ID 1002
City
Brussels
Country
Belgium
Facility Name
Investigator ID 1003
City
Brussels
Country
Belgium
Facility Name
Investigator ID 1004
City
Brussels
Country
Belgium
Facility Name
Investigator ID 1107
City
Olomouc
Country
Czechia
Facility Name
Investigator ID 1101
City
Prague
Country
Czechia
Facility Name
Investigator ID 1102
City
Prague
Country
Czechia
Facility Name
Investigator ID 1103
City
Prague
Country
Czechia
Facility Name
Investigator ID 1104
City
Prague
Country
Czechia
Facility Name
Investigator ID 1108
City
Prague
Country
Czechia
Facility Name
Investigator ID 1109
City
Teplice
Country
Czechia
Facility Name
Investigator ID 1106
City
Zlin
Country
Czechia
Facility Name
Investigator ID 1204
City
Copenhagen
Country
Denmark
Facility Name
Investigator ID 1205
City
Herlev
Country
Denmark
Facility Name
Investigator ID 1202
City
Hvidovre
Country
Denmark
Facility Name
Investigator ID 1203
City
Skive
Country
Denmark
Facility Name
Investigator ID 1301
City
Tartu
Country
Estonia
Facility Name
Investigator ID 1303
City
Tartu
Country
Estonia
Facility Name
Investigator ID 1401
City
Helsinki
Country
Finland
Facility Name
Investigator ID 1402
City
Helsinki
Country
Finland
Facility Name
Investigator ID 1403
City
Oulu
Country
Finland
Facility Name
Investigator ID 1501
City
Heidelberg
Country
Germany
Facility Name
Investigator ID 1502
City
Lübeck
Country
Germany
Facility Name
Investigator ID 1504
City
Mainz
Country
Germany
Facility Name
Investigator ID 1503
City
Marburg
Country
Germany
Facility Name
Investigator ID 1601
City
Budapest
Country
Hungary
Facility Name
Investigator ID 1604
City
Budapest
Country
Hungary
Facility Name
Investigator ID 1603
City
Pécs
Country
Hungary
Facility Name
Investigator ID 1602
City
Tapolca
Country
Hungary
Facility Name
Investigator ID 1701
City
Białystok
Country
Poland
Facility Name
Investigator ID 1703
City
Białystok
Country
Poland
Facility Name
Investigator ID 1705
City
Białystok
Country
Poland
Facility Name
Investigator ID 1702
City
Katowice
Country
Poland
Facility Name
Investigator ID 1704
City
Szczecin
Country
Poland
Facility Name
Investigator ID 1706
City
Warsaw
Country
Poland
Facility Name
Investigator ID 1801
City
Barakaldo
Country
Spain
Facility Name
Investigator ID 1805
City
Barcelona
Country
Spain
Facility Name
Investigator ID 1808
City
Barcelona
Country
Spain
Facility Name
Investigator ID 1809
City
Leioa
Country
Spain
Facility Name
Investigator ID 1804
City
Madrid
Country
Spain
Facility Name
Investigator ID 1807
City
Madrid
Country
Spain
Facility Name
Investigator ID 1811
City
Sevilla
Country
Spain
Facility Name
Investigator ID 1806
City
Valencia
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

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

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