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Trial record 2 of 4570 for:    IMPLANT 2

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

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ClinicalTrials.gov Identifier: NCT03081208
Recruitment Status : Active, not recruiting
First Posted : March 16, 2017
Last Update Posted : July 17, 2019
Sponsor:
Information provided by (Responsible Party):
ObsEva SA

Tracking Information
First Submitted Date  ICMJE March 6, 2017
First Posted Date  ICMJE March 16, 2017
Last Update Posted Date July 17, 2019
Actual Study Start Date  ICMJE March 6, 2017
Actual Primary Completion Date March 21, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03081208 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2017)
  • Live birth [ Time Frame: Up to 42 weeks of gestation ]
    Live birth after 24 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
  • 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
  • Positive blood pregnancy test [ Time Frame: 14 days post OPU ]
    Positive blood pregnancy test at 14 days post oocyte pick-up (OPU)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 9, 2017)
  • Adverse events [ Time Frame: Through study completion, up to 11 months ]
    Frequency and severity of treatment emergent adverse events
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Phase 3 Placebo Controlled Study of Nolasiban to Improve Pregnancy Rates in Women Undergoing IVF/ICSI
Official Title  ICMJE 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
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).
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)
Masking Description:
Double Blind
Primary Purpose: Treatment
Condition  ICMJE Infertility
Intervention  ICMJE
  • Drug: Nolasiban 900mg
    Nolasiban dispersible tablets for single oral administration
  • Drug: Placebo
    Placebo dispersible tablets for single oral administration
Study Arms  ICMJE
  • Experimental: Nolasiban 900 mg
    Intervention: Drug: Nolasiban 900mg
  • Placebo Comparator: Placebo
    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
Estimated Enrollment  ICMJE
 (submitted: March 9, 2017)
760
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2019
Actual Primary Completion Date March 21, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 36 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,   Czechia,   Denmark,   Estonia,   Finland,   Germany,   Hungary,   Poland,   Spain
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT03081208
Other Study ID Numbers  ICMJE 16-OBE001-005
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
Study Director: ObsEva SA Geneva
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