Gene Expression in Cumulus Cells to Predict Pregnancy

The Predictive Value of a Gene Expression Signature in Cumulus Cells Indicative of Embryo Implantation.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01732900

Enrollment

133

Registered

2012-11-26

Start date

2013-02-28

Completion date

2014-03-31

Last updated

2014-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

In vitro fertilization, Assisted reproduction, pregnancy outcome, cumulus cells

Brief summary

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.

Interventions

OTHERMorphology

Embryos selected for transfer will be based upon morphology alone.

OTHERGemART assay

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

21 Years to 39 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Clinical pregnancy rate	Recorded at post-transfer week 4-9	Clinical pregnancy, recorded as either positive or negative, will be determined using vaginal ultrasound during post-transfer week 4-9. Clinical Pregnancy rate for embryos selected using the GemART assay in conjunction with morphology will be compared with clinical pregnancy rate for embryos selected using morphology alone.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026