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.

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