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

Infertility Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02788617
• Other study ID #: DFT-MD-05
• Status: Completed
• Phase: N/A
• First received: April 26, 2016
• Last updated: July 28, 2017
• Start date: June 24, 2016
• Est. completion date: April 4, 2017

Study information

• Verified date: July 2017
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 4, 2017
• Est. primary completion date: January 30, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

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

Locations

Country	Name	City	State
United States	Main Line Fertility Center	Bryn Mawr	Pennsylvania
United States	Institute for Reproductive Health	Cincinnati	Ohio
United States	Women's Medical Research Group	Clearwater	Florida
United States	Dallas - Fort Worth Fertility Associates	Dallas	Texas
United States	Huntington Reproductive Center	Encino	California
United States	InVia Fertility Specialists	Hoffman Estates	Illinois
United States	Houston Fertility Institute	Houston	Texas
United States	Utah Fertiity Center	Pleasant Grove	Utah
United States	Reproductive Care Center	Sandy City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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