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Completed

NCT Number: NCT02788617

Evaluation of the Efficacy of Diafert 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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Huntington Reproductive Center, Encino, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diafert

Device

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

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

    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.

Sponsors and collaborators

Lead sponsor

Forest Laboratories

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 2, 2016
Registry last updated
Jul 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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