Diafert® for Embryo Selection and Fertility Improvement

Last updated: July 28, 2017
Sponsor: Forest Laboratories
Overall Status: Completed

Phase

3

Condition

Infertility

Treatment

N/A

Clinical Study ID

NCT02593461
0040-101
  • Ages > 18
  • Female

Study Summary

Prospective, single-center, single-blind, randomized, controlled, two-arm, interventional study.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Women at least 18 years old at the time of Informed Consent.

  2. Able to understand and voluntarily sign an Informed Consent form approved by therelevant Independent Ethics Committee (IEC) governing the site.

  3. First or second fresh Assisted Reproductive Technology (ART) cycle attempt (since lastsuccessful implantation, if any).

  4. Eligible for elective SET of fresh embryo on Day 2/3. Elective SET is defined as atransfer for which there is more than one embryo in the same morphological ("best")category as that of the selected embryo.

Exclusion

Exclusion Criteria:

  1. Presence or history of ovarian endometriotic cyst.

  2. Presence or history of diagnosed severe endometriosis (i.e. stage IV of the revisedAmerican Fertility Society classification for endometriosis).

  3. Hormonal, functional, anatomical and/or other abnormalities potentially increasing therisk of miscarriage and/or ectopic pregnancy as judged by the Investigator anddetermined by medical history and clinical laboratory. This includes, but is notlimited to, uncontrolled diabetes mellitus, uncontrolled thyroid disease, alcoholism,drug abuse, abnormal uterine cavity etc.

  4. History of two or more consecutive miscarriages.

  5. Known history of human immunodeficiency virus, Hepatitis C virus and/or Hepatitis Bvirus infection.

  6. The subject has other serious or acute conditions that, in the Investigator's opinion,would preclude her participation in the study.

  7. Need for preimplantation genetic diagnosis/screening.

  8. Use of time-lapse embryo imaging

  9. Participating in oocyte donation procedure.

  10. Participation in any interventional drug clinical investigation within 2 months

  11. Dependency on sponsor or investigator (e.g. co-worker or family member).

Study Design

Total Participants: 14
Study Start date:
October 22, 2015
Estimated Completion Date:
April 07, 2017

Connect with a study center

  • Centre D'Assistance Médicale À La Procréation

    Schiltigheim, 67300
    France

    Site Not Available

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