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Evaluation of Donated Human Embryos Following in Vitro Fertilization

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ClinicalTrials.gov Identifier: NCT01219361
Recruitment Status : Enrolling by invitation
First Posted : October 13, 2010
Last Update Posted : March 26, 2018
Sponsor:
Information provided by (Responsible Party):
Reproductive Medicine Associates of New Jersey

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.

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

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
Estimated 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 : July 2005
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2025



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples With DNA
Donated embryos


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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:

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01219361


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

Additional Information:
Responsible Party: Reproductive Medicine Associates of New Jersey
ClinicalTrials.gov Identifier: NCT01219361     History of Changes
Other Study ID Numbers: RMA-00-05
First Posted: October 13, 2010    Key Record Dates
Last Update Posted: March 26, 2018
Last Verified: March 2018

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