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

December 20, 2019 updated by: ObsEva SA

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
810

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
Placebo dispersible tablets for single oral administration
Experimental: Nolasiban 900 mg
Drug: Nolasiban 900mg
Nolasiban dispersible tablets for single oral administration

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Intra-uterine pregnancy with fetal heart beat at 10 weeks
Time Frame: 10 weeks post ET day
Intra-uterine pregnancy with fetal heart beat at 10 weeks post embryo transfer day
10 weeks post ET day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Live birth
Time Frame: Up to 42 weeks of gestation
Live birth after 24 weeks of gestation
Up to 42 weeks of gestation
Miscarriage
Time Frame: From 6 weeks post ET to 24 weeks gestation
Any clinical pregnancy that does not result in a live birth prior 24 weeks
From 6 weeks post ET to 24 weeks gestation
Intra-uterine pregnancy at 6 weeks
Time Frame: 6 weeks post ET
Intra-uterine pregnancy with fetal heart beat at 6 weeks post ET day
6 weeks post ET
Positive blood pregnancy test
Time Frame: 14 days post OPU
Positive blood pregnancy test at 14 days post oocyte pick-up (OPU)
14 days post OPU

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: Through study completion, up to 11 months
Frequency and severity of treatment emergent adverse events
Through study completion, up to 11 months
Neonatal assessments
Time Frame: Birth of infant until 28 days
Incidence of any malformation or any significant morbidity during the neonatal period
Birth of infant until 28 days
ASQ-3
Time Frame: 6 months after term
Ages and Stages Questionnaire-3 (ASQ-3) domain score(s) at 6 months, adjusted for gestational age at birth
6 months after term

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ObsEva SA

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: ObsEva SA, Geneva

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 6, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 21, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 19, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 6, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 23, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16-OBE001-005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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