CompletedPhase 3

Diafert® for Embryo Selection and Fertility Improvement

France14 participantsStarted 2015-10-22

Plain-language summary

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

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Women at least 18 years old at the time of Informed Consent.
✓. Able to understand and voluntarily sign an Informed Consent form approved by the relevant Independent Ethics Committee (IEC) governing the site.
✓. First or second fresh Assisted Reproductive Technology (ART) cycle attempt (since last successful implantation, if any).
✓. Eligible for elective SET of fresh embryo on Day 2/3. Elective SET is defined as a transfer for which there is more than one embryo in the same morphological ("best") category as that of the selected embryo.

✕. Presence or history of ovarian endometriotic cyst.
✕. Presence or history of diagnosed severe endometriosis (i.e. stage IV of the revised American Fertility Society classification for endometriosis).
✕. Hormonal, functional, anatomical and/or other abnormalities potentially increasing the risk of miscarriage and/or ectopic pregnancy as judged by the Investigator and determined by medical history and clinical laboratory. This includes, but is not limited to, uncontrolled diabetes mellitus, uncontrolled thyroid disease, alcoholism, drug abuse, abnormal uterine cavity etc.
✕. History of two or more consecutive miscarriages.
✕. Known history of human immunodeficiency virus, Hepatitis C virus and/or Hepatitis B virus infection.
✕. The subject has other serious or acute conditions that, in the Investigator's opinion, would preclude her participation in the study.
✕. Need for preimplantation genetic diagnosis/screening.
✕. Use of time-lapse embryo imaging

Percentage of successful implantations

Timeframe: At Week 6

NCT IDNCT02593461

SponsorForest Laboratories

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-12-15

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Women at least 18 years old at the time of Informed Consent.
✓. Able to understand and voluntarily sign an Informed Consent form approved by the relevant Independent Ethics Committee (IEC) governing the site.
✓. First or second fresh Assisted Reproductive Technology (ART) cycle attempt (since last successful implantation, if any).
✓. Eligible for elective SET of fresh embryo on Day 2/3. Elective SET is defined as a transfer for which there is more than one embryo in the same morphological ("best") category as that of the selected embryo.

✕. Presence or history of ovarian endometriotic cyst.
✕. Presence or history of diagnosed severe endometriosis (i.e. stage IV of the revised American Fertility Society classification for endometriosis).
✕. Hormonal, functional, anatomical and/or other abnormalities potentially increasing the risk of miscarriage and/or ectopic pregnancy as judged by the Investigator and determined by medical history and clinical laboratory. This includes, but is not limited to, uncontrolled diabetes mellitus, uncontrolled thyroid disease, alcoholism, drug abuse, abnormal uterine cavity etc.
✕. History of two or more consecutive miscarriages.
✕. Known history of human immunodeficiency virus, Hepatitis C virus and/or Hepatitis B virus infection.
✕. The subject has other serious or acute conditions that, in the Investigator's opinion, would preclude her participation in the study.
✕. Need for preimplantation genetic diagnosis/screening.
✕. Use of time-lapse embryo imaging