Clinical trial NCT02593461: Diafert® for Embryo Selection and Fertility Improvement
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infertility
Keywords: Embryo Transfer
Embryo Selection Criteria for Implantation
Assisted Reproductive Technology
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2015-11-01
Enrollment: 14
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Percentage of successful implantations
timeFrame: At Week 6
Secondary outcomes:
measure: Percentage of live births
timeFrame: Approximately Week 40 (pregnancy outcome)
Other outcomes:
Locations:
city: Schiltigheim
country: France
facility: Centre D'Assistance Médicale À La Procréation
Study officials:
affiliation: Forest Laboratories, an affiliate of Allergan plc
name: Tennador Sanderson
role: STUDY_DIRECTOR
References: