Evaluation of Discarded Laboratory Pathological Specimens and Media

Completed

• Conditions: Serum; Follicular Fluid; Non-viable Oocytes; Extra Spermatozoa; Seminal Fluid; Granulosa Cells; Conditioned IVF Media

• Registration Number: NCT01219439
• Lead Sponsor: Reproductive Medicine Associates of New Jersey

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 Timeline

• Study Start: 2007-07
• Study First Submitted: 2010-10-08
• Study First Submitted QC: 2010-10-12
• Study First Posted: 2010-10-13
• Primary Completion: 2022-12
• Study Completion: 2022-12
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-02
• Last Update Posted: 2023-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

none

Exclusion Criteria

none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

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