Evaluation of the Efficacy of Diafert in Predicting Embryos' Potential to Develop to the Blastocyst Stage
- Conditions
- Infertility
- Interventions
- Device: Diafert
- Registration Number
- NCT02788617
- Lead Sponsor
- Forest Laboratories
- Brief Summary
This prospective study will evaluate the efficacy of Diafert as an adjunct to morphological assessment in predicting embryos' potential to develop to the blastocyst stage on Day 5.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 100
- Provide written informed consent before initiation of any study procedures
- Be a female outpatient, ≥ 18 years of age at the time of informed consent
- Have at minimum 10 mature egg follicles as of the last transvaginal ultrasound following hormonal stimulation
- Eligible to allow embryos to develop through day 5 before implantation or freezing
- Presence of ovarian endometriotic cyst
- Presence or history of diagnosed severe endometriosis (i.e. stage IV the revised American Fertility Society classification for endometriosis).
- Need for pre-implantation genetic diagnosis/screening of embryos
- Use of time-lapse embryo imaging
- Employee or immediate relative of an employee of Forest Research Institute, Inc., any of its affiliates or partners, or the study center
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Non treatment group Diafert This is a non-interventional study in which embryo selection is performed according to standard of care. The Diafert output, the granulocyte colony-stimulating factor (G-CSF) concentration in follicular fluid (FF), will be recorded but will not be used in patient management, ie, values will not be used for embryo selection in the assisted reproduction procedure.
- Primary Outcome Measures
Name Time Method Number of Embryos that achieve the blastocyst stage of development at Day 5 as determined by morphological assessment using the SART criteria Day 5 The status of each embryo will be assessed by an independent panel of 5 embryologists through visual inspection using the Society for Assisted Reproductive Technology (SART) criteria to determine if each embryo has achieved the blastocyst stage of development or not.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
Utah Fertiity Center
🇺🇸Pleasant Grove, Utah, United States
Main Line Fertility Center
🇺🇸Bryn Mawr, Pennsylvania, United States
InVia Fertility Specialists
🇺🇸Hoffman Estates, Illinois, United States
Huntington Reproductive Center
🇺🇸Encino, California, United States
Reproductive Care Center
🇺🇸Sandy City, Utah, United States
Women's Medical Research Group
🇺🇸Clearwater, Florida, United States
Institute for Reproductive Health
🇺🇸Cincinnati, Ohio, United States
Dallas - Fort Worth Fertility Associates
🇺🇸Dallas, Texas, United States
Houston Fertility Institute
🇺🇸Houston, Texas, United States