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CompletedNCT02586272DESTINyUpdated Aug 1, 2017

Diafert for Embryo Selection and Fertility Improvement

A Phase 3 interventional study of Daifert and Control Group in Infertility, sponsored by Forest Laboratories. Completed at 1 site in Belgium. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-08-01.

Sponsored by Forest Laboratories · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Nov 2014, registered Oct 2015).
Phase
Phase 3
Study type
Interventional
Enrollment
61
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

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

02

Conditions studied

  • Infertility

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Keywords

  • Embryo Transfer
  • assisted reproductive technology
03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's enrollment of 61 is below the median of 120 across 1,698 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Forest Laboratories is the lead sponsor of 165 studies on the registry; none are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

    1. Women at least 18 years old at the time of informed consent.
    1. Able to understand and voluntarily sign an Informed Consent form approved by the relevant Independent Ethics Committee (IEC) governing the site.
    1. First or second fresh Assisted Reproductive Technology (ART) cycle attempt (since last successful implantation, if any).
    1. 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

Exclusion Criteria:

    1. Presence or history of ovarian endometriotic cyst.
    1. Presence or history of diagnosed severe endometriosis (i.e. stage IV the revised American Fertility Society classification for endometriosis).
    1. 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.
    1. History of two or more consecutive miscarriages.
    1. Known history of human immunodeficiency virus, Hepatitis C virus and/or Hepatitis B virus infection.
    1. The subject has other serious or acute conditions that, in the Investigator's opinion, would preclude her participation in the study.
    1. Need for preimplantation genetic diagnosis/screening.
    1. Use of time-lapse embryo imaging.
    1. Participating in oocyte donation procedure.
    1. Participation in any interventional drug clinical investigation within 2 months prior to screening.
    1. Dependency on sponsor or investigator (e.g. co-worker or family member).
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
61 participants (actual)

Study arms

  • 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

Interventions

  • DeviceDaifert
  • ProcedureControl Group

    Also known as: Control - Morphological Assessment

06

What researchers measure

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.

    Time frame: At Week 6

Secondary outcomes

  1. 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.

    Time frame: Approximately Week 40 (pregnancy outcome)

07

Study locations

1 site
  • Leuven University Fertility Center
    Leuven, B-3000, Belgium
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 1, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02586272
Lead sponsor
Forest Laboratories
Responsible party
Sponsor
First posted
Oct 26, 2015
Start date
Nov 25, 2014
Primary completion
Feb 22, 2017
Completion
Apr 7, 2017
Last update
Aug 1, 2017

Study contacts

Tennador Sanderson
study director · Forest Laboratories, an affiliate of Allergan plc

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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