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

NCT02788617 | Completed

• 1 other identifier: DFT-MD-05
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 9

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.

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

Diafert DEVICE

The Diafert output, the G-CSF concentration in FF, will be recorded but will not be used in patient management.

Non treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female outpatients involved in an assisted reproduction procedure.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Forest Laboratories: lead

Study Sites (9)

Huntington Reproductive Center

Encino, California, 91436, United States

Location

Women's Medical Research Group

Clearwater, Florida, 33759, United States

Location

InVia Fertility Specialists

Hoffman Estates, Illinois, 60169, United States

Location

Institute for Reproductive Health

Cincinnati, Ohio, 45209, United States

Location

Main Line Fertility Center

Bryn Mawr, Pennsylvania, 19010, United States

Location

Dallas - Fort Worth Fertility Associates

Dallas, Texas, 75231, United States

Location

Houston Fertility Institute

Houston, Texas, 77063, United States

Location

Utah Fertiity Center

Pleasant Grove, Utah, 84062, United States

Location

Reproductive Care Center

Sandy City, Utah, 84092, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Human follicular fluid

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Fabian Somers, PhD

  Allergan

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2016
• First Posted: June 2, 2016
• Study Start: June 24, 2016
• Primary Completion: January 30, 2017
• Study Completion: April 4, 2017
• Last Updated: July 31, 2017

Record last verified: 2017-07

Locations

US (9)