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Evaluation of the Efficacy of Diafert in Predicting Embryos' Potential to Develop to the Blastocyst Stage

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ClinicalTrials.gov Identifier: NCT02788617
Recruitment Status : Completed
First Posted : June 2, 2016
Last Update Posted : July 31, 2017
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories

Study Description
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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.

Condition or disease Intervention/treatment
Infertility Device: Diafert

Study Design
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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Non-interventional, Multicenter, Clinical Study to Evaluate the Efficacy of the Diafert G-CSF ELISA as an Adjunct to Morphological Assessment in Predicting Embryos' Potential to Develop to the Blastocyst Stage
Actual Study Start Date : June 24, 2016
Actual Primary Completion Date : January 30, 2017
Actual Study Completion Date : April 4, 2017
Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 Device: Diafert
The Diafert output, the G-CSF concentration in FF, will be recorded but will not be used in patient management.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Embryos that achieve the blastocyst stage of development at Day 5 as determined by morphological assessment using the SART criteria [ Time Frame: 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.


Biospecimen Retention:   Samples Without DNA
Human follicular fluid

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Female outpatients involved in an assisted reproduction procedure.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02788617


Locations
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United States, California
Huntington Reproductive Center
Encino, California, United States, 91436
United States, Florida
Women's Medical Research Group
Clearwater, Florida, United States, 33759
United States, Illinois
InVia Fertility Specialists
Hoffman Estates, Illinois, United States, 60169
United States, Ohio
Institute for Reproductive Health
Cincinnati, Ohio, United States, 45209
United States, Pennsylvania
Main Line Fertility Center
Bryn Mawr, Pennsylvania, United States, 19010
United States, Texas
Dallas - Fort Worth Fertility Associates
Dallas, Texas, United States, 75231
Houston Fertility Institute
Houston, Texas, United States, 77063
United States, Utah
Utah Fertiity Center
Pleasant Grove, Utah, United States, 84062
Reproductive Care Center
Sandy City, Utah, United States, 84092
Sponsors and Collaborators
Forest Laboratories
Investigators
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Study Director: Fabian Somers, PhD Allergan
More Information
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Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT02788617    
Other Study ID Numbers: DFT-MD-05
First Posted: June 2, 2016    Key Record Dates
Last Update Posted: July 31, 2017
Last Verified: July 2017
Additional relevant MeSH terms:
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Infertility