Diafert for Embryo Selection and Fertility Improvement (DESTINy)

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02593513
• Date of registration: 22/10/2015
• Prospective Registration: Yes
• Primary sponsor: Forest Laboratories
• Public title: Diafert for Embryo Selection and Fertility Improvement (DESTINy) DESTINy
• Scientific title: 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
• Date of first enrolment: October 26, 2015
• Target sample size: 108
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02593513
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
• Phase: Phase 3

Countries of recruitment

Hungary

Contacts

• Name: Tennador Sanderson
• Affiliation: Forest Laboratories, an affiliate of Allergan plc

Key inclusion & exclusion 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 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).



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Infertility

Intervention(s)

Device: Daifert

Procedure: Control Group

Primary Outcome(s)

Percentage of successful implantations [Time Frame: At Week 6]

Secondary Outcome(s)

Percentage of live births [Time Frame: Approximately Week 40 (pregnancy outcome)]

Secondary ID(s)

0040-103

Source(s) of Monetary Support

Please refer to primary and secondary sponsors