Overview

This trial is active, not recruiting.

Condition infertility
Treatments daifert, control group
Phase phase 3
Sponsor Forest Laboratories
Start date November 2014
End date August 2016
Trial size 61 participants
Trial identifier NCT02586272, 0040-100, 2014-001635-36

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
• 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.
daifert
(Other)
Control Group: The embryo to be transferred is selected on the basis of morphological assessment performed on Day 2 or 3.
control group Control - Morphological Assessment

Primary Outcomes

Measure
Percentage of successful implantations
time frame: At Week 6

Secondary Outcomes

Measure
Percentage of live births
time frame: Approximately Week 40 (pregnancy outcome)

Eligibility Criteria

Female participants at least 18 years old.

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).

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Forest Laboratories.