Correlating Time-Lapse Parameters With aCGH Testing in IVF Treatment (aCGH Study)

Progyny

Status: Unknown

Conditions: Infertility

Study type: Observational

Funder types: Industry

Identifiers

NCT02141685

2014-AUX-011

Details and patient eligibility

About

The purpose of this research study protocol is to collect imaging data on embryos followed to blastocyst stage (Day 5-6) and correlate Eeva parameters with array - Comparative Genomic Hybridization (aCGH) results and ongoing pregnancy rates.

Full description

The present study was designed to determine if there is a correlation between the Eeva System parameters and aCGH testing results. Embryos will be selected for transfer based on aCGH results and morphology. The Clinical site will have no access to the Eeva analysis at the time of the transfer.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18 to 43 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject is ≤43 years of age.
• Women undergoing IVF treatment with planned aCGH testing using her own eggs or donor eggs.
• Antral Follicle Count ≥ 6 at time of cycle start
• Baseline (day 2-3 of cycling) FSH ≤ 15 mIU/ml
• Antimüllerian Hormone level ≥ 0.5 ng/mL
• Fertilization using only ejaculated sperm (fresh or frozen) - no surgically retrieved sperm.
• Willing to have all 2PN embryos monitored by Eeva
• Not previously enrolled in this study.
• Willing to comply with study protocol and procedures and able to speak English.
• Willing to provide written informed consent.

Exclusion criteria

• BMI ≥ 40
• Prior IVF cycle with < 4 x 2PN
• Planned Day 3 Assisted Hatching

Trial design

50 participants in 1 patient group

IVF patients undergoing aCGH Testing

Description:

Women undergoing fresh IVF treatment and array-comparative genomic hybridization testing (aCGH), as recommended based on medical need by the clinical site reproductive endocrinologist.