Study of Gene Associations and Infertility
This study is ongoing, but not recruiting participants.
Sponsor:
Reproductive Medicine Associates of New Jersey
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
| Tracking Information | |||||||||
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| First Received Date ICMJE | October 8, 2010 | ||||||||
| Last Updated Date | January 22, 2013 | ||||||||
| Start Date ICMJE | February 2006 | ||||||||
| Estimated Primary Completion Date | December 2015 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Number of retrieved oocytes [ Time Frame: 1 month ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01223092 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Study of Gene Associations and Infertility | ||||||||
| Official Title ICMJE | Genes and Gene Polymorphisms Associated With Infertility: Utilization of DNA Characteristics to Better Understand Reproductive Competence | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: whole blood serum, follicular fluid and sperm |
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Patients undergoing infertility treamtnet |
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| Condition ICMJE | Infertility | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Patients undegoing infertility treatment
Male and female patients undergoing infertility treatment |
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| 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):1290-6. Epub 2008 Oct 17. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||
| Estimated Enrollment ICMJE | 5000 | ||||||||
| Estimated Completion Date | December 2016 | ||||||||
| Estimated Primary Completion Date | December 2015 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 50 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01223092 | ||||||||
| Other Study ID Numbers ICMJE | RMA-00-10 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Reproductive Medicine Associates of New Jersey | ||||||||
| Study Sponsor ICMJE | Reproductive Medicine Associates of New Jersey | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Reproductive Medicine Associates of New Jersey | ||||||||
| Verification Date | January 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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