Diafert for Embryo Selection and Fertility Improvement

NCT02586272 | Completed Phase 3

• 2 other identifiers: 0040-1002014-001635-36
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Infertility

Keywords

Embryo Transfer; assisted reproductive technology

Outcome Measures

Primary Outcomes (1)

• Percentage of successful implantations

  The percentage of successful implantation 6 weeks after oocyte retrieval (±3 days), i.e. at approximately 8 weeks gestational age (±3 days) or 8 weeks of amenorrhea (± 3 days), in each group (Control and Interventional groups), overall and within each morphological embryo category, when elective Single Embryo Transfer (SET) is performed on Day 2 or 3. Successful implantation is defined as the presence in the uterus of at least one gestational sac with fetal heart activity identified on ultrasound.

  At Week 6

Secondary Outcomes (1)

• Percentage of live births

  Approximately Week 40 (pregnancy outcome)

Study Arms (2)

Daifert

EXPERIMENTAL

• 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.

Device: Daifert

Control Group

OTHER

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

Procedure: Control Group

Interventions

Daifert DEVICE

Daifert

Control Group PROCEDURE

Also known as: Control - Morphological Assessment

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• \. Presence or history of ovarian endometriotic cyst.
• \. Presence or history of diagnosed severe endometriosis (i.e. stage IV the revised American Fertility Society classification for endometriosis).
• \. 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.
• \. 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.
• \. Participating in oocyte donation procedure.
• \. Participation in any interventional drug clinical investigation within 2 months prior to screening.
• \. Dependency on sponsor or investigator (e.g. co-worker or family member).

Sponsors & Collaborators

• Forest Laboratories: lead

Study Sites (1)

Leuven University Fertility Center

Leuven, B-3000, Belgium

Location

MeSH Terms

Conditions

Infertility

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Tennador Sanderson

  Forest Laboratories, an affiliate of Allergan plc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2015
• First Posted: October 26, 2015
• Study Start: November 25, 2014
• Primary Completion: February 22, 2017
• Study Completion: April 7, 2017
• Last Updated: August 1, 2017

Record last verified: 2017-07

Locations

BE (1)