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

July 9, 2015 updated by: Progyny, Inc.

Correlating Time-Lapse Parameters Detected by Eeva™ With Array-Comparative Genomic Hybridization Results and Ongoing Pregnancy Rates (aCGH Study)

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.

Study Overview

Status

Unknown

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Bryn Mawr, Pennsylvania, United States, 19010
        • Main Line Fertility

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women undergoing fresh IVF treatment and undergoing aCGH testing, as recommended based on medical need by the clinical site reproductive endocrinologist.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eeva time-lapse parameters and aCGH testing results
Time Frame: 5-6 days
Analysis of correlation between time-lapse parameters collected by the Eeva System and array-Comparative Genomic Hybridization (aCGH) results
5-6 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Embryo Implantation Rate
Time Frame: 6 weeks
Correlation of time-lapse parameters collected by Eeva and implantation rate
6 weeks
Clinical Pregnancy Rate
Time Frame: 6 weeks
Correlation of time-lapse parameters collected by Eeva and clinical pregnancy rate
6 weeks
Ongoing pregnancy rate
Time Frame: 8-12 weeks
Correlation of time-lapse parameters collected by Eeva and ongoing pregnancy rate
8-12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Progyny, Inc.

Investigators

  • Study Director: Shehua Shen, MD, ELD, Progyny, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Anticipated)

February 1, 2016

Study Completion (Anticipated)

February 1, 2016

Study Registration Dates

First Submitted

May 13, 2014

First Submitted That Met QC Criteria

May 15, 2014

First Posted (Estimate)

May 19, 2014

Study Record Updates

Last Update Posted (Estimate)

July 13, 2015

Last Update Submitted That Met QC Criteria

July 9, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-AUX-011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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