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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

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.

Condition or disease Intervention/treatment Phase
Infertility Drug: Nolasiban Drug: Placebo Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 820 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 10, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : January 2021

Arm Intervention/treatment
Experimental: Nolasiban 900 mg
Nolasiban dispersible tablets for single oral administration
Drug: Nolasiban
Nolasiban single oral administration

Placebo Comparator: Placebo
Placebo dispersible tablets for single oral administration
Drug: Placebo
Placebo single oral administration




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Live birth [ Time Frame: 24 to 40 weeks of gestation ]
    Live birth after 24 weeks of gestation

  2. 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

  3. 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

  4. 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

  5. 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


Other Outcome Measures:
  1. Adverse events [ Time Frame: Through study completion, up to 11 months ]
    Treatment emergent adverse events frequency and severity

  2. Neonatal assessments [ Time Frame: Birth of infant until 28 days ]
    Incidence of any malformation or any significant morbidity during the neonatal period

  3. 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.



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Ages Eligible for Study:   18 Years to 37 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03758885


  Hide Study Locations
Locations
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Belgium
Site 1001
Brussels, Belgium
Site 1003
Brussels, Belgium
Site 1004
Brussels, Belgium
Site 1002
Brussel, Belgium
Canada
Site 1404
Burnaby, Canada
Site 1401
Montréal, Canada
Site 1402
Toronto, Canada
Site 1403
Toronto, Canada
Czechia
Site 1107
Olomouc, Czechia
Site 1101
Praha, Czechia
Site 1102
Praha, Czechia
Site 1103
Praha, Czechia
Site 1104
Praha, Czechia
Site 1105
Praha, Czechia
Site 1108
Praha, Czechia
Site 1110
Praha, Czechia
Site 1109
Teplice, Czechia
Site 1106
Zlín, Czechia
Denmark
Site 1205
Herlev, Denmark
Site 1202
Hvidovre, Denmark
Site 1204
Kobenhavn, Denmark
Site 1203
Skive, Denmark
Estonia
Site 1302
Tallinn, Estonia
Site 1301
Tartu, Estonia
Site 1303
Tartu, Estonia
Germany
Site 1504
Berlin, Germany
Site 1506
Berlin, Germany
Site 1505
Bielefeld, Germany
Site 1501
Heidelberg, Germany
Site 1502
Lubeck, Germany
Site 1503
Marburg, Germany
Hungary
Site 1601
Budapest, Hungary
Site 1603
Budapest, Hungary
Site 1602
Tapolca, Hungary
Poland
Site 1703
Białystok, Poland
Site 1705
Białystok, Poland
Site 1702
Katowice, Poland
Site 1701
Kraków, Poland
Site 1704
Szczecin, Poland
Site 1706
Warsaw, Poland
Russian Federation
Site 1902
Ekaterinburg, Russian Federation
Site 1901
Moscow, Russian Federation
Site 1905
Moscow, Russian Federation
Site 1904
Samara, Russian Federation
Spain
Site 1805
Barcelona, Spain
Site 1808
Barcelona, Spain
Site 1809
Leioa, Spain
Site 1804
Madrid, Spain
Site 1807
Madrid, Spain
Site 1811
Sevilla, Spain
Sponsors and Collaborators
ObsEva SA

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Responsible Party: ObsEva SA
ClinicalTrials.gov Identifier: NCT03758885     History of Changes
Other Study ID Numbers: 18-OBE001-010
First Posted: November 29, 2018    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ObsEva SA:
IVF
ICSI
ART
ET
Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female