Evaluation of Donated Human Embryos Following in Vitro Fertilization

May 2, 2023 updated by: Reproductive Medicine Associates of New Jersey

Evaluation of Donated Human Embryos for Study of Normal and Abnormal Differentiation and Development Following in Vitro Fertilization.

Couples who have created excess embryos while undergoing IVF procedures, and who do not wish to transfer those embryos or donate them to another couple may donate the extra embryos to research. The embryos are then used to develop improved laboratory techniques and conditions as well as testing the proficiency of laboratory staff.

Study Overview

Status

Enrolling by invitation

Conditions

Detailed Description

Undergoing IVF treatment often results in the production of more embryos than can safely be transferred at one time. These extra embryos are often cryopreserved for future use. In the event that a couple decides that they do not want to proceed with using cryopreserved embryos, these embryos can be discarded, donated to another couple, or donated to research.

Embryos that are donated to research are used to identify a group of parameters that have significant predictive value for assisted reproductive technology outcomes. We hope to develop future laboratory techniques as we gain a better knowledge of gamete development, fertilization and implantation. We will test, standardize and implement better methods for freezing embryos prior to employing these techniques in a clinical setting. We hope to develop new methods to optimize the determination of genes and chromosomes in embryos. We will test the proficiency of laboratory staff on techniques and/or procedures done in the IVF laboratory. This study WILL NOT:create embryos for research, transfer embryos to an individual, develop cell lines or clones.

Study Type

Observational

Enrollment (Anticipated)

5000

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
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Reproductive Medicine Assoicates of New Jersey

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

All patients will cryopreserved embryos who do not want to discard them or donate them to another couple

Description

Inclusion Criteria:

none

Exclusion Criteria:

none

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freezing methods for embryos
Time Frame: duration of the study
To test, standardize and implement better methods for the freezing of embryos prior to these techniques being implemented in the clinical setting.
duration of the study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development of New Methods
Time Frame: duration of the study
The development of new methods to optimize the determination of genes and chromosomes in embryos
duration of the study

Collaborators and Investigators

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

Sponsor

Reproductive Medicine Associates of New Jersey

Investigators

  • Principal Investigator: Thomas Molinaro, MD, MSCE, Reproductive Medicine Associates of New Jersey

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

July 1, 2005

Primary Completion (Anticipated)

December 1, 2025

Study Completion (Anticipated)

December 1, 2026

Study Registration Dates

First Submitted

October 8, 2010

First Submitted That Met QC Criteria

October 8, 2010

First Posted (Estimate)

October 13, 2010

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

May 2, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RMA-00-05

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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