Evaluation of Donated Human Embryos Following in Vitro Fertilization

• Conditions: Validation of Laboratory Techniques; Assessment of Laboratory Staff Proficiency; Validation of Laboratory Methods

• Registration Number: NCT01219361
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2005-07
• Study First Submitted: 2010-10-08
• Study First Submitted QC: 2010-10-08
• Study First Posted: 2010-10-13
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-07
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

none

Exclusion Criteria

none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Development of New Methods	duration of the study	The development of new methods to optimize the determination of genes and chromosomes in embryos

Trial Locations

Locations (1)

Reproductive Medicine Assoicates of New Jersey; 🇺🇸 Basking Ridge, New Jersey, United States