Diafert for Embryo Selection and Fertility Improvement (DESTINy)

Forest Laboratories

Status and phase: Completed; Phase 3

Conditions: Infertility

Treatments: Device: Daifert; Procedure: Control Group

Study type: Interventional

Funder types: Industry

Identifiers

NCT02593513

0040-103

Details and patient eligibility

About

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

Enrollment: 108 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 the relevant Independent Ethics Committee (IEC) governing the site.
3. First or second fresh Assisted Reproductive Technology (ART) cycle attempt (since last successful implantation, if any).
4. 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.

Exclusion criteria

1. Presence or history of ovarian endometriotic cyst.
2. Presence or history of diagnosed severe endometriosis (i.e. stage IV of the revised American Fertility Society classification for endometriosis).
3. 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.
4. History of two or more consecutive miscarriages.
5. Known history of human immunodeficiency virus, Hepatitis C virus and/or Hepatitis B virus 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 prior to screening.
11. Dependency on sponsor or investigator (e.g. co-worker or family member).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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108 participants in 2 patient groups

Daifert

Experimental group

Description:

The embryo to be transferred is selected on the basis of both morphological assessment performed on Day 2 or 3 and FF G-CSF concentration. FF G-CSF concentration will be measured with the Diafert® immunoassay.

Treatment:

Device: Daifert

Control Group

Other group

Description:

The embryo to be transferred is selected on the basis of morphological assessment performed on Day 2 or 3.

Treatment:

Procedure: Control Group