Evaluation of the Efficacy of Diafert in Predicting Embryos' Potential to Develop to the Blastocyst Stage
NCT ID: NCT02788617
Last Updated: 2017-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
100 participants
OBSERVATIONAL
2016-06-24
2017-04-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Non treatment group
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.
Diafert
The Diafert output, the G-CSF concentration in FF, will be recorded but will not be used in patient management.
Interventions
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Diafert
The Diafert output, the G-CSF concentration in FF, will be recorded but will not be used in patient management.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Forest Laboratories
INDUSTRY
Responsible Party
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Principal Investigators
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Fabian Somers, PhD
Role: STUDY_DIRECTOR
Allergan
Locations
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Huntington Reproductive Center
Encino, California, United States
Women's Medical Research Group
Clearwater, Florida, United States
InVia Fertility Specialists
Hoffman Estates, Illinois, United States
Institute for Reproductive Health
Cincinnati, Ohio, United States
Main Line Fertility Center
Bryn Mawr, Pennsylvania, United States
Dallas - Fort Worth Fertility Associates
Dallas, Texas, United States
Houston Fertility Institute
Houston, Texas, United States
Utah Fertiity Center
Pleasant Grove, Utah, United States
Reproductive Care Center
Sandy City, Utah, United States
Countries
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Other Identifiers
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DFT-MD-05
Identifier Type: -
Identifier Source: org_study_id