Evaluation of Donated Human Embryos Following in Vitro Fertilization

Assessment of Laboratory Staff Proficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01219361
• Other study ID #: RMA-00-05
• Status: Enrolling by invitation
• Start date: July 2005
• Est. completion date: December 2026

Study information

• Verified date: May 2023
• Source: Reproductive Medicine Associates of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 5000
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

none

Exclusion Criteria:

none

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	Reproductive Medicine Assoicates of New Jersey	Basking Ridge	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Reproductive Medicine Associates of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freezing methods for embryos	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	Development of New Methods	The development of new methods to optimize the determination of genes and chromosomes in embryos	duration of the study

External Links

•   Reproductive Medicine Associates of New Jersey