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

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Forest Laboratories

Status

Completed

Conditions

Infertility

Treatments

Device: Diafert

Study type

Observational

Funder types

Industry

Identifiers

NCT02788617
DFT-MD-05

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

Non treatment group
Description:
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.
Treatment:
Device: Diafert

Trial contacts and locations

9

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Data sourced from clinicaltrials.gov

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