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

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

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.

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Device: Diafert

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • California
    • Encino, California, United States, 91436
      • Huntington Reproductive Center
  • Florida
    • Clearwater, Florida, United States, 33759
      • Women's Medical Research Group
  • Illinois
    • Hoffman Estates, Illinois, United States, 60169
      • InVia Fertility Specialists
  • Ohio
    • Cincinnati, Ohio, United States, 45209
      • Institute for Reproductive Health
  • Pennsylvania
    • Bryn Mawr, Pennsylvania, United States, 19010
      • Main Line Fertility Center
  • Texas
    • Dallas, Texas, United States, 75231
      • Dallas - Fort Worth Fertility Associates
    • Houston, Texas, United States, 77063
      • Houston Fertility Institute
  • Utah
    • Pleasant Grove, Utah, United States, 84062
      • Utah Fertiity Center
    • Sandy City, Utah, United States, 84092
      • Reproductive Care Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Female outpatients involved in an assisted reproduction procedure.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Embryos that achieve the blastocyst stage of development at Day 5 as determined by morphological assessment using the SART criteria	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.	Day 5

Collaborators and Investigators

• Sponsor: Forest Laboratories
• Investigators: Study Director: Fabian Somers, PhD, Allergan

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2016
• Primary Completion (Actual): January 30, 2017
• Study Completion (Actual): April 4, 2017

Study Registration Dates

• First Submitted: April 26, 2016
• First Submitted That Met QC Criteria: May 27, 2016
• First Posted (Estimate): June 2, 2016

Study Record Updates

• Last Update Posted (Actual): July 31, 2017
• Last Update Submitted That Met QC Criteria: July 28, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: DFT-MD-05