Diafert for Embryo Selection and Fertility Improvement

NCT ID: NCT02586272

Last Updated: 2017-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-25
• Study Completion Date: 2017-04-07

Brief Summary

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

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Daifert

• Interventional Group: 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.

Group Type: EXPERIMENTAL

Daifert

Intervention Type: DEVICE

Control Group

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

Group Type: OTHER

Control Group

Intervention Type: PROCEDURE

Interventions

Daifert

Intervention Type: DEVICE

Control Group

Intervention Type: PROCEDURE

Other Intervention Names

Control - Morphological Assessment

Eligibility Criteria

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 the revised American Fertility Society classification for endometriosis).
• 3. Hormonal, functional, anatomical and/or any 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Forest Laboratories

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tennador Sanderson

Role: STUDY_DIRECTOR

Forest Laboratories, an affiliate of Allergan plc

Locations

Leuven University Fertility Center

Leuven, , Belgium

Countries

Belgium

Other Identifiers

2014-001635-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

0040-100

Identifier Type: -

Identifier Source: org_study_id