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Study of Gene Associations and Infertility

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01223092
First Posted: October 18, 2010
Last Update Posted: March 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Reproductive Medicine Associates of New Jersey
  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:


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

Primary Outcome Measures:
  • Number of retrieved oocytes [ Time Frame: 1 month ]

Secondary Outcome Measures:
  • Fertilization rate [ Time Frame: 1 month ]
    Number of oocytes that are fertilized

  • Number of available embryos [ Time Frame: 1 month ]
    Number of embryos that are available for transfer on day 3 or day 5

  • Pregnancy rates [ Time Frame: 1 year ]
    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 2019
Estimated Primary Completion Date: December 2018 (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Reproductive Medicine Associates of New Jersey
ClinicalTrials.gov Identifier: NCT01223092     History of Changes
Other Study ID Numbers: RMA-00-10
First Submitted: October 8, 2010
First Posted: October 18, 2010
Last Update Posted: March 17, 2017
Last Verified: March 2017

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

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