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NCT01223092 Clinical Trial

Study of Gene Associations and Infertility

Infertility Clinical Trial

Official title:
Genes and Gene Polymorphisms Associated With Infertility: Utilization of DNA Characteristics to Better Understand Reproductive Competence

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT01223092
Other study ID # RMA-00-10
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date February 2006
Est. completion date December 2026

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 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.

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 5000
Est. completion date December 2026
Est. primary completion date December 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - all patients undergoing fertility care Exclusion Criteria: - none

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Reproductive Medicine Associates 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, 

References & Publications (1)

Patounakis G, Treff N, Tao X, Lonczak A, Scott RT Jr, Frattarelli JL. The p53 codon 72 single nucleotide polymorphism lacks a significant effect on implantation rate in fresh in vitro fertilization cycles: an analysis of 1,056 patients. Fertil Steril. 2009 Oct;92(4):1290-1296. doi: 10.1016/j.fertnstert.2008.07.1783. Epub 2008 Oct 17. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Number of retrieved oocytes 1 month
Secondary Fertilization rate Number of oocytes that are fertilized 1 month
Secondary Number of available embryos Number of embryos that are available for transfer on day 3 or day 5 1 month
Secondary Pregnancy rates Clinical pregnancy rates (detection of pregnancy hormone bHCG in blood) and delivery rates. 1 year
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