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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01219439
Other study ID # RMA-00-14
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 2007
Est. completion date December 2022

Study information

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

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 10000
Est. completion date December 2022
Est. primary completion date December 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: none Exclusion Criteria: none

Study Design


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 Methods for the freezing of ooyctes and sperm To test, standardize and implement better methods for the freezing of ooyctes and sperm prior to these techniques being used in the clinical setting. duration of study
Secondary New methods of gene and chromosome analysis The development of new methods to optimize the determination of genes and chromosomes in gametes. duration of study
See also
  Status Clinical Trial Phase
Completed NCT04077970 - Intrauterine Flushing With Follicular Fluid Plus Granulosa Cells Phase 3