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Study of Gene Associations and Infertility

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ClinicalTrials.gov Identifier: NCT01223092
Recruitment Status : Enrolling by invitation
First Posted : October 18, 2010
Last Update Posted : March 26, 2018
Sponsor:
Information provided by (Responsible Party):
Reproductive Medicine Associates of New Jersey

Brief Summary:
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 or disease
Infertility

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.

Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Genes and Gene Polymorphisms Associated With Infertility: Utilization of DNA Characteristics to Better Understand Reproductive Competence
Study Start Date : February 2006
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Patients undegoing infertility treatment
Male and female patients undergoing infertility treatment



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

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

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

  3. 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


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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:


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
Basking Ridge, New Jersey, United States, 07920
Sponsors and Collaborators
Reproductive Medicine Associates of New Jersey
Investigators
Principal Investigator: Richard T Scott, MD Reproductive Medicine Associates of New Jersey

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 Posted: October 18, 2010    Key Record Dates
Last Update Posted: March 26, 2018
Last Verified: March 2018

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

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