Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 2 for:    nolasiban
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03758885
Recruitment Status : Active, not recruiting
First Posted : November 29, 2018
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
ObsEva SA

Tracking Information
First Submitted Date  ICMJE November 28, 2018
First Posted Date  ICMJE November 29, 2018
Last Update Posted Date July 24, 2019
Actual Study Start Date  ICMJE January 10, 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 28, 2018)
Ongoing pregnancy with fetal heart beat at 10 weeks [ Time Frame: 10 weeks post ET day ]
Ongoing pregnancy defined as an intra-uterine pregnancy with fetal heart beat at 10 weeks post embryo transfer day
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03758885 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2019)
  • Live birth [ Time Frame: 24 to 40 weeks of gestation ]
    Live birth after 24 weeks of gestation
  • Clinical pregnancy at 6 weeks post ET day [ Time Frame: 6 weeks post ET ]
    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) [ Time Frame: 14 days post OPU ]
    Positive blood pregnancy test at 14 days post OPU day
  • Pregnancy loss [ Time Frame: 6 weeks post ET to 24 weeks gestation ]
    Pregnancy loss at 6 or 10 weeks after ET and before 24 weeks of gestation
  • Plasma concentrations of nolasiban [ Time Frame: 3.5 hours, 5 hours and at 7 hours (latest 72 hours) after nolasiban administration ]
    Plasma concentrations of nolasiban after administration
Original Secondary Outcome Measures  ICMJE
 (submitted: November 28, 2018)
  • Live birth [ Time Frame: 24 to 40 weeks of gestation ]
    Live birth after 24 weeks of gestation
  • Clinical pregnancy at 6 weeks post ET day [ Time Frame: 6 weeks post ET ]
    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) [ Time Frame: 14 days post OPU ]
    Positive blood pregnancy test at 14 days post OPU day
  • Pregnancy loss [ Time Frame: 6 weeks post ET to 24 weeks gestation ]
    Pregnancy loss at 6 or 10 weeks after ET and before 24 weeks of gestation
  • Serum concentrations of nolasiban [ Time Frame: 1 hour before ET ]
    Serum concentrations of nolasiban up to 1 h before ET
Current Other Pre-specified Outcome Measures
 (submitted: February 8, 2019)
  • Adverse events [ Time Frame: Through study completion, up to 11 months ]
    Treatment emergent adverse events frequency and severity
  • Neonatal assessments [ Time Frame: Birth of infant until 28 days ]
    Incidence of any malformation or any significant morbidity during the neonatal period
  • Ages and Stages Questionnaires® (ASQ-3™) 6 and 12 month Questionnaire [ Time Frame: 6 and 12 months after term ]
    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.
Original Other Pre-specified Outcome Measures
 (submitted: November 28, 2018)
  • Adverse events [ Time Frame: Through study completion, up to 11 months ]
    Treatment emergent adverse events frequency and severity
  • Neonatal assessments [ Time Frame: Birth of infant until 28 days ]
    Incidence of any malformation or any significant morbidity during the neonatal period
  • 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
 
Descriptive Information
Brief Title  ICMJE Study of Nolasiban to Increase Pregnancy Rates in Women Undergoing IVF
Official Title  ICMJE 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
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Infertility
Intervention  ICMJE
  • Drug: Nolasiban
    Nolasiban single oral administration
  • Drug: Placebo
    Placebo single oral administration
Study Arms  ICMJE
  • Experimental: Nolasiban 900 mg
    Nolasiban dispersible tablets for single oral administration
    Intervention: Drug: Nolasiban
  • Placebo Comparator: Placebo
    Placebo dispersible tablets for single oral administration
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 28, 2018)
820
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2021
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 37 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Canada,   Czechia,   Denmark,   Estonia,   Germany,   Hungary,   Poland,   Russian Federation,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03758885
Other Study ID Numbers  ICMJE 18-OBE001-010
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ObsEva SA
Study Sponsor  ICMJE ObsEva SA
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account ObsEva SA
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP