Gene Expression in Cumulus Cells to Predict Pregnancy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

133 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Morphology

Embryos selected for transfer will be based on morphology alone.

Group Type ACTIVE_COMPARATOR

Morphology

Intervention Type OTHER

Embryos selected for transfer will be based upon morphology alone.

GemART assay

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

Group Type EXPERIMENTAL

GemART assay

Intervention Type OTHER

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

Interventions

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Morphology

Embryos selected for transfer will be based upon morphology alone.

Intervention Type OTHER

GemART assay

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No