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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 : July 26, 2018
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 900mg dose of nolasiban to increase the ongoing clinical pregnancy rate at 10 weeks post embryo transfer (ET) day.

Condition or disease Intervention/treatment Phase
Infertility Drug: Nolasiban 900mg Drug: Placebo Phase 3

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 760 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double Blind
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 6, 2017
Actual Primary Completion Date : March 21, 2018
Estimated Study Completion Date : April 2019

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

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Live birth [ Time Frame: Up to 42 weeks of gestation ]
    Live birth after 24 weeks of gestation

  2. 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

  3. 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

  4. Positive blood pregnancy test [ Time Frame: 14 days post OPU ]
    Positive blood pregnancy test at 14 days post oocyte pick-up (OPU)


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

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

  3. 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



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Ages Eligible for Study:   18 Years to 36 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03081208


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

Responsible Party: ObsEva SA
ClinicalTrials.gov Identifier: NCT03081208     History of Changes
Other Study ID Numbers: 16-OBE001-005
First Posted: March 16, 2017    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: July 2018

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

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female