Menu
Enrolling by invitation NCT01223092

Study of Gene Associations and Infertility

Observational Infertility

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Infertility. Basic parameters: 18 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Primary outcome measures

  • Number of retrieved oocytes [Time frame: 1 month]
Secondary outcome measures (3)
  • Fertilization rate [Time frame: 1 month]
  • Number of available embryos [Time frame: 1 month]
  • Pregnancy rates [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • all patients undergoing fertility care

Exclusion criteria

  • none

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Reproductive Medicine Associates of New Jersey — Basking Ridge

Publications

  • 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. PMID 18930193
  • Patounakis G, Bergh E, Forman EJ, Tao X, Lonczak A, Franasiak JM, Treff N, Scott RT Jr. Multiple thrombophilic single nucleotide polymorphisms lack a significant effect on outcomes in fresh IVF cycles: an analysis of 1717 patients. J Assist Reprod Genet. 2016 Jan;33(1):67-73. doi: 10.1007/s10815-015-0606-z. Epub 2015 Nov 6. PMID 26545911

Identifiers

NCT: NCT01223092 · RMA-00-10

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗