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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 : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
ObsEva SA

March 6, 2017
March 16, 2017
November 6, 2017
March 6, 2017
March 2018   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT03081208 on ClinicalTrials.gov Archive Site
  • 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)
Same as current
  • 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
Same as current
 
Phase 3 Placebo Controlled Study of Nolasiban to Improve Pregnancy Rates in Women Undergoing IVF/ICSI
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.
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).
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Double Blind
Primary Purpose: Treatment
Infertility
  • Drug: Nolasiban 900mg
    Nolasiban dispersible tablets for single oral administration
  • Drug: Placebo
    Placebo dispersible tablets for single oral administration
  • Experimental: Nolasiban 900 mg
    Intervention: Drug: Nolasiban 900mg
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
760
Same as current
April 2019
March 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 36 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Czechia,   Denmark,   Estonia,   Finland,   Germany,   Hungary,   Poland,   Spain
Czech Republic
 
NCT03081208
16-OBE001-005
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
ObsEva SA
ObsEva SA
Not Provided
Study Director: ObsEva SA Geneva
ObsEva SA
November 2017

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