Infertility
Conditions
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.
Interventions
DEVICEDiafert
The Diafert output, the G-CSF concentration in FF, will be recorded but will not be used in patient management.
Sponsors
Forest Laboratories
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Embryos that achieve the blastocyst stage of development at Day 5 as determined by morphological assessment using the SART criteria | 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. |
Countries
United States
Outcome results
None listed