Diafert® for Embryo Selection and Fertility Improvement

Infertility Clinical Trial

— DESTINy  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02593461
• Other study ID #: 0040-101
• Status: Completed
• Phase: Phase 3
• First received: October 22, 2015
• Last updated: July 28, 2017
• Start date: October 22, 2015
• Est. completion date: April 7, 2017

Study information

• Verified date: July 2017
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: April 7, 2017
• Est. primary completion date: December 15, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

11. Dependency on sponsor or investigator (e.g. co-worker or family member).

Related Conditions & MeSH terms

• Infertility

Intervention

Device:
• Daifert

Other:
• Control Group

Locations

Country	Name	City	State
France	Centre D'Assistance Médicale À La Procréation	Schiltigheim

Sponsors (1)

Lead Sponsor	Collaborator
Forest Laboratories

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)