Evaluation of Discarded Laboratory Pathological Specimens and Media

Sponsor
Reproductive Medicine Associates of New Jersey (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01219439
Collaborator
(none)
10,000
1
221
45.2

Study Details

Study Description

Brief Summary

The researchers propose to investigate the causes, incidence, and time-related events of chromosomal and physiologic abnormalities as they relate to patient diagnosis, fertility drugs utilized, and in vitro laboratory culture conditions.

Detailed Description

We propose to identify a group of parameters that have significant predictive value for assisted reproductive technology outcomes. We seek to test, standardize and implement better methods for the freezing of oocytes and sperm prior to these techniques being used in the clinical setting. We seek to develop new methods to optimize the determination of genes and chromosomes in gametes. We hope to develop new cell surgery or micromanipulation techniques (e.g. use of cell drills and lasers in order to enhance the efficiency of procedures such as ICSI, assisted hatching, biopsy) as well as other manipulations. We will test the safety and efficiency of micro fluidics and automation in the Embryology lab. This has the potential to reduce cost, human errors, temperature and physical changes. We hope to develop new methods and media and media supplements normally found in the reproductive tract that allow for higher survival of gametes in vitro. We will also test the proficiency of laboratory staff members on techniques and/or procedures performed in the in-vitro fertilization laboratory. We will perform Quality Control to review how changes in temperature and setting can effect specimens

Study Design

Study Type:
Observational
Anticipated Enrollment :
10000 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Laboratory Evaluation of IVF Discarded Pathological Specimens and Media for Optimization of Techniques for Assisted Reproduction
Study Start Date :
Jul 1, 2007
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2025

Outcome Measures

Primary Outcome Measures

  1. Methods for the freezing of ooyctes and sperm [duration of study]

    To test, standardize and implement better methods for the freezing of ooyctes and sperm prior to these techniques being used in the clinical setting.

Secondary Outcome Measures

  1. New methods of gene and chromosome analysis [duration of study]

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

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

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:
NCT01219439
Other Study ID Numbers:
  • RMA-00-14
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