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

NCT ID: NCT02141685

Last Updated: 2015-07-13

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

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Study Completion Date

2016-02-29

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Infertility

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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IVF patients undergoing aCGH Testing

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

43 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Progyny, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shehua Shen, MD, ELD

Role: STUDY_DIRECTOR

Progyny, Inc.

Locations

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Main Line Fertility

Bryn Mawr, Pennsylvania, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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2014-AUX-011

Identifier Type: -

Identifier Source: org_study_id

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