Dr. Shraddha Ramchandani
Hyderabad, Telangana, 500082, India
Location contact
Manjula Bhanoori
CONTACT
Shraddha Ramchandani
CONTACT
NCT Number: NCT06102629
OBJECTIVES:
1. Analysis of DNA methyl transferases (DNMT1, DNMT3A and DNMT3B) and Histone deacetylases (HDAC 1,2,3 and SIRTs) polymorphisms (Somatic and germ line variations). 2. Analysis of differential mRNA and protein expression of epigenetic markers in ovarian tissues obtained from PCOS patients. 3. miRNA regulated epigenetic mechanisms in PCOS 4. Epigenetic regulation of endocrine genes in PCOS
DESIGN : A Case Control study.Sample size:200
Trial opening soon.
Get Notified18 year–45 year
All sexes
Interventional
Not applicable
Hyderabad, Telangana, 500082, India
Manjula Bhanoori
CONTACT
Shraddha Ramchandani
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Criteria for the diagnosis of PCOS would include oligo-ovulation cycles longer than 35 days or less than 26 days, elevated free testosterone levels (0.5 ng/dl; the cutof level for free testosterone level was the mean±2 SD according to normal levels in controls), oligomenorrhea or amenorrhea.
A Ferriman-Gallwey (FG) score of≥7 would be taken as indicator for the presence of hirsutism. In accordance with the above criteria, polycystic ovary morphology would be determined by transvaginal ultrasonography, which defines PCOS as the presence of 12 or more small (2-9 mm) follicles in each ovary.
Control subjects would have no signs of menstrual dysfunction and their androgen levels should be within the normal range, with normal glucose tolerance, and no family history of hirsutism, type 2 diabetes mellitus, and infertility.
Exclusion criteria
.We will take both blood and ovarian tissue samples used to diagnosis. 2.We will take approximately 3 ml of blood which will be used from the blood sample collected for routine preoperative tests (surgical profile) before their planned surgery or for disease evaluation.
Time frame: 3 YEARS
DNA will be extracted as per the protocol followed routinely in our lab from blood and ovarian tissues.
Time frame: 3 YEARS
Total RNA from ovarian tissue will be extracted using TRIzol reagent according to the manufacturer's instructions (Invitrogen Life Technologies) and reverse transcribed in the presence of random hexamers. Quantitative real-time PCR reactions will be carried out in an ABI 7000 Thermal Cycler (Applied Biosystems) to analyse the expression of epigenetic markers including the androgen regulated miRNAs and their downstream targets.
Time frame: 3 YEARS
The present study would investigate the expression pattern of DNMTs, HDACs, miRNAs and their downstream targets in Ovarian tissues (samples of normal adult ovaries and polycystic ovaries) by western blot and immunohistochemical analysis (IHC).
Contact information is provided by the study sponsor or research team.
Manjula Bhanoori
CONTACT
Shraddha Ramchandani
CONTACT
Asian Institute of Gastroenterology, India
Other
Understanding the Epigenetic Mechanisms in the Pathophysiology of Polycystic Ovary Syndrome for Efficient Diagnosis and Targeted Therapy
Acronym: PCOS-01
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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