Evaluation of Discarded Laboratory Pathological Specimens and Media

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Reproductive Medicine Associates of New Jersey
ClinicalTrials.gov Identifier:
NCT01219439
First received: October 8, 2010
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

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.


Condition
Non-viable Oocytes
Extra Spermatozoa
Seminal Fluid
Granulosa Cells
Serum
Follicular Fluid
Conditioned IVF Media

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Laboratory Evaluation of IVF Discarded Pathological Specimens and Media for Optimization of Techniques for Assisted Reproduction

Further study details as provided by Reproductive Medicine Associates of New Jersey:

Primary Outcome Measures:
  • Methods for the freezing of ooyctes and sperm [ Time Frame: duration of study ] [ Designated as safety issue: No ]
    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:
  • New methods of gene and chromosome analysis [ Time Frame: duration of study ] [ Designated as safety issue: No ]
    The development of new methods to optimize the determination of genes and chromosomes in gametes.


Biospecimen Retention:   Samples With DNA

Samples with DNA: Non-viable oocytes, spermatozoa, granulosa cells and follicular fluid Samples without DNA: seminal fluid, serum and conditioned IVF media


Estimated Enrollment: 10000
Study Start Date: July 2007
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

All patients undergoing infertility treatment.

Criteria

Inclusion Criteria:

none

Exclusion Criteria:

none

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01219439

Locations
United States, New Jersey
Reproductive Medicine Assoicates of New Jersey
Morristown, New Jersey, United States, 09760
United States, Pennsylvania
Reproductive Medicine Associates 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
  More Information

Additional Information:
No publications provided

Responsible Party: Reproductive Medicine Associates of New Jersey
ClinicalTrials.gov Identifier: NCT01219439     History of Changes
Other Study ID Numbers: RMA-00-14
Study First Received: October 8, 2010
Last Updated: June 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Reproductive Medicine Associates of New Jersey:
discarded pathological specimens
discarded media
IVF

ClinicalTrials.gov processed this record on October 20, 2014