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Study of Gene Associations and Infertility

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Reproductive Medicine Associates of New Jersey
ClinicalTrials.gov Identifier:
NCT01223092
First received: October 8, 2010
Last updated: January 22, 2013
Last verified: January 2013
History of Changes
  Purpose

The purpose of this this study is to use DNA screening strategies to identify genes and localize genomic regions that are differentially expressed in patients with infertility to further understand the genetic basis for reproductive competence.


Condition
Infertility

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Genes and Gene Polymorphisms Associated With Infertility: Utilization of DNA Characteristics to Better Understand Reproductive Competence

Resource links provided by NLM:

MedlinePlus related topics: Infertility
U.S. FDA Resources

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

Primary Outcome Measures:
  • Number of retrieved oocytes [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fertilization rate [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Number of oocytes that are fertilized

  • Number of available embryos [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Number of embryos that are available for transfer on day 3 or day 5

  • Pregnancy rates [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Clinical pregnancy rates (detection of pregnancy hormone bHCG in blood) and delivery rates.


Biospecimen Retention:   Samples With DNA

whole blood serum, follicular fluid and sperm


Estimated Enrollment: 5000
Study Start Date: February 2006
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients undegoing infertility treatment
Male and female patients undergoing infertility treatment

Detailed Description:

Experimental strategies seek to discover small variants in DNA sequences, which are associated with certain infertility parameters. The alleles being analyzed in in vitro fertilization (IVF) population are sought to be associated with functional differences in the expression of the gene product that are then mechanistically linked to infertility.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients undergoing infertility treamtnet

Criteria

Inclusion Criteria:

  • all patients undergoing fertility care

Exclusion Criteria:

  • none
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01223092

Locations
United States, New Jersey
Reproductive Medicine Associates of New Jersey
Morristown, New Jersey, United States, 07960
Sponsors and Collaborators
Reproductive Medicine Associates of New Jersey
Investigators
Principal Investigator: Richard T Scott, MD Reproductive Medicine Associates of New Jersey
Study Director: Nathan R Treff, PhD Reproductive Medicine Associates of New Jersey
  More Information

Additional Information:
Reproductive Medicine Associates of New Jersey  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Reproductive Medicine Associates of New Jersey
ClinicalTrials.gov Identifier: NCT01223092     History of Changes
Other Study ID Numbers: RMA-00-10
Study First Received: October 8, 2010
Last Updated: January 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Reproductive Medicine Associates of New Jersey:
IVF
infertility
DNA

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 22, 2013