Polycystic Ovary Syndrome Clinical Trial
Official title:
Whole Genome Analysis for the Detection of Key Genes in the Polycystic Ovary Syndrome - a Study on Multigenerational Families
NCT number | NCT00665171 |
Other study ID # | pcodsnp |
Secondary ID | |
Status | Not yet recruiting |
Phase | N/A |
First received | April 18, 2008 |
Last updated | April 22, 2008 |
Start date | June 2008 |
Verified date | April 2008 |
Source | Maaynei Hayesha Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | Israel: Ministry of Health |
Study type | Observational |
Background: Infertility affects up to 15% of married couples. About half are attributable to
female factors, among which anovulation is the leading cause. Some 5% of all women of
reproductive age are anovulatory due to the polycystic ovarian syndrome (PCOS). PCOS causes
also major health and cosmetic problems and significantly affects quality of life. PCOS is
associated with cardiovascular morbidity and Type 2 diabetes mellitus, but it is unclear
whether these are caused by the ovarian dysfunction or result from a common denominator.
Working hypothesis and aims: Whole genome analysis of multigenerational families in which at
least one woman is affected by PCOS may significantly reduce the numbers needed to verify
the specific genes, involved in the causation of PCOS.
Methods: Registration of multigenerational families and production of personal files with
full workup for the presence of PCOS or its absence (in the women participants). Drawing of
blood, extraction and preservation of DNA. Analysis of all informative SNPs in the genomes
of the participants on a specific microarray chip. Statistical analysis of the results.
Expected results: Verification of the loci and putative genes, associated with the
appearance of PCOS.
Importance: Elucidation of the specific genes underlying the pathology of PCOS. Probable
implications to Medicine: Paving the way for targeted treatment of the problems, associated
with PCOS, based on the clear knowledge of its underlying cause(s).
Status | Not yet recruiting |
Enrollment | 1500 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - A clinical and laboratory diagnosis of the polycystic ovary syndrome (cases). Female family members of index cases, up to a great grandmother and fathers of index cases. Exclusion Criteria: |
Observational Model: Family-Based, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Israel | Department of Obstetrics and Gynecology, Maaynei Hayeshua Medical Center | Bnei Brak |
Lead Sponsor | Collaborator |
---|---|
Maaynei Hayesha Medical Center |
Israel,
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