Evaluation of Donated Human Embryos Following in Vitro Fertilization

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Reproductive Medicine Associates of New Jersey
ClinicalTrials.gov Identifier:
NCT01219361
First received: October 8, 2010
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

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.


Condition
Validation of Laboratory Techniques
Validation of Laboratory Methods
Assessment of Laboratory Staff Proficiency

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Evaluation of Donated Human Embryos for Study of Normal and Abnormal Differentiation and Development Following in Vitro Fertilization.

Further study details as provided by Reproductive Medicine Associates of New Jersey:

Primary Outcome Measures:
  • Freezing methods for embryos [ Time Frame: duration of the study ] [ Designated as safety issue: No ]
    To test, standardize and implement better methods for the freezing of embryos prior to these techniques being implemented in the clinical setting.


Secondary Outcome Measures:
  • Development of New Methods [ Time Frame: duration of the study ] [ Designated as safety issue: No ]
    The development of new methods to optimize the determination of genes and chromosomes in embryos


Biospecimen Retention:   Samples With DNA

Donated embryos


Estimated Enrollment: 5000
Study Start Date: July 2005
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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

Criteria

Inclusion Criteria:

none

Exclusion Criteria:

none

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01219361

Locations
United States, Connecticut
Reproductive Medicine Associates of Connecticut
Norwalk, Connecticut, United States, 06850
United States, Michigan
Reproductive Medicine Associates of Michigan
Troy, Michigan, United States, 48084
United States, New Jersey
Reproductive Medicine Assoicates of New Jersey
Morristown, New Jersey, United States, 07690
United States, New York
Reproductive Medicine Associates of New York
New York, New York, United States, 10022
United States, Pennsylvania
Reproductive Medicine Assoicates of PA at Lehigh Valley
Allentown, Pennsylvania, United States, 18104
Sponsors and Collaborators
Reproductive Medicine Associates of New Jersey
Investigators
Principal Investigator: Richard T Scott, MD Reproductive Medicine Associates of New Jersey
  More Information

Additional Information:
No publications provided

Responsible Party: Reproductive Medicine Associates of New Jersey
ClinicalTrials.gov Identifier: NCT01219361     History of Changes
Other Study ID Numbers: RMA-00-05
Study First Received: October 8, 2010
Last Updated: June 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Reproductive Medicine Associates of New Jersey:
Donated embryos

ClinicalTrials.gov processed this record on October 23, 2014