Diafert for Embryo Selection and Fertility Improvement (DESTINy)

A Prospective, Single-center, Randomized, Two-arm, Interventional Study to Evaluate the Implantation Rate of Embryos Selected on the Basis of Morphology and Granulocyte-Colony Stimulating Factor (G-CSF) Concentration in the Ovarian Follicular Fluid (FF) - FF G-CSF - Compared to the Implantation Rate of Embryos Selected on the Basis of Morphology Alone When Elective Single Embryo Transfer (SET) of a Fresh Embryo is Performed on Day 2/3 After Oocyte Retrieval.

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

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Device: Daifert; Procedure: Control Group

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, B-3000
    • Leuven University Fertility Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Daifert
Other: Control Group; Control Group: The embryo to be transferred is selected on the basis of morphological assessment performed on Day 2 or 3.	Procedure: Control Group; Other Names: Control - Morphological Assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of live births	Percentage of live birth in the Control group and in the Interventional group when elective SET of a fresh embryo is performed on Day 2 or 3 after oocyte retrieval.	Approximately Week 40 (pregnancy outcome)

Collaborators and Investigators

• Sponsor: Forest Laboratories
• Investigators: Study Director: Tennador Sanderson, Forest Laboratories, an affiliate of Allergan plc

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2014
• Primary Completion (Actual): February 22, 2017
• Study Completion (Actual): April 7, 2017

Study Registration Dates

• First Submitted: October 22, 2015
• First Submitted That Met QC Criteria: October 23, 2015
• First Posted (Estimate): October 26, 2015

Study Record Updates

• Last Update Posted (Actual): August 1, 2017
• Last Update Submitted That Met QC Criteria: July 28, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Embryo Transfer; assisted reproductive technology
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: 0040-100; 2014-001635-36 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No