Gene Expression in Cumulus Cells to Predict Pregnancy

Gema Diagnostics

Status: Completed

Conditions: Infertility

Treatments: Other: GemART assay; Other: Morphology

Study type: Interventional

Funder types: Industry

Identifiers

NCT01732900

GEMA-201201

Details and patient eligibility

About

The purpose of this study is to determine the performance of a genetic assay, GemART, in cumulus cells predictive of embryo viability, and pregnancy success in women undergoing in vitro fertilization (IVF). Performance is defined as success rate per embryo transferred, as measured by the implantation rate of embryos transferred.

Enrollment: 133 patients

Sex: Female

Ages: 21 to 39 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 21-39 years
• IVF cycle 1 or 2
• BMI <35
• Fertilization method: ICSI and/or IVF
• Day 3 or day 5 embryo transfer
• Treatment cycle intended for single or double embryo transfer
• Use own oocytes, not oocyte donor
• ≥ 3 embryos at final assessment
• Donor sperm acceptable
• Willing to comply with protocol and study procedures

Exclusion criteria

• Polycystic Ovarian Syndrome
• Presence of fibroid(s): >4 cm intramural or submucosal fibroids
• History of chemotherapy or radiation to the abdomen or pelvis
• Use of donor oocytes
• Use of reinseminated oocytes
• Preimplantation genetic diagnosis or preimplantation genetic screening during current IVF cycle
• Concurrent participation in another clinical study
• (Male): Surgically removed sperm
• (Male): <5 million sperm count

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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133 participants in 2 patient groups

Morphology

Active Comparator group

Description:

Embryos selected for transfer will be based on morphology alone.

Treatment:

Other: Morphology

GemART assay

Experimental group

Description:

Embryos selected for transfer will be based upon morphology and GemART assay.

Treatment:

Other: GemART assay