Evaluation of Donated Human Embryos Following in Vitro Fertilization

Sponsor
Reproductive Medicine Associates of New Jersey (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT01219361
Collaborator
(none)
5,000
2
257
2500
9.7

Study Details

Study Description

Brief Summary

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.

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 Design

Study Type:
Observational
Anticipated Enrollment :
5000 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Evaluation of Donated Human Embryos for Study of Normal and Abnormal Differentiation and Development Following in Vitro Fertilization.
Study Start Date :
Jul 1, 2005
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2026

Outcome Measures

Primary Outcome Measures

  1. Freezing methods for embryos [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.

Secondary Outcome Measures

  1. Development of New Methods [duration of the study]

    The development of new methods to optimize the determination of genes and chromosomes in embryos

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

none

Exclusion Criteria:

none

Contacts and Locations

Locations

Site City State Country Postal Code
1 Reproductive Medicine Assoicates of New Jersey Basking Ridge New Jersey United States 07920
2 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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Reproductive Medicine Associates of New Jersey
ClinicalTrials.gov Identifier:
NCT01219361
Other Study ID Numbers:
  • RMA-00-05
First Posted:
Oct 13, 2010
Last Update Posted:
Jan 14, 2022
Last Verified:
Jan 1, 2022
Keywords provided by Reproductive Medicine Associates of New Jersey

Study Results

No Results Posted as of Jan 14, 2022