Studies how epigenetic changes relate to polycystic ovary syndrome in women
Compares gene-regulation markers in ovarian tissue from women with polycystic ovary syndrome and others.
Plain-language title generated from the registry record
Registry title: Ovary Syndrome for Efficient Diagnosis and Targeted Therapy
Key facts
- Where
- Hyderabad, IndiaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women of Indian origin aged 18 to 45. Some have polycystic ovary syndrome (PCOS), and some are controls without PCOS.
- Age
- 18 to 45 years
- Sex
- All sexes listed in the record, but the criteria describe women of reproductive age.
- Disease stage
- Cases: PCOS diagnosed by the Rotterdam criteria (cycles longer than 35 days or shorter than 26 days, high free testosterone, irregular or missing periods, or 12 or more small follicles in each ovary). Controls: no menstrual problems and normal androgen levels.
- Biomarker or test result
- Cases: free testosterone of 0.5 ng/dl or higher. Controls: androgen levels in the normal range and normal glucose tolerance.
Main reasons for not taking part
- Other causes of high male hormone levels, such as high prolactin, androgen-secreting tumors, Cushing syndrome or nonclassic congenital hyperplasia
- Controls with menstrual problems or abnormal androgen levels
- Controls with a family history of hirsutism, type 2 diabetes or infertility
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 45 years old?
Source: NCT06102629, who can take part
Where in India
- Dr. Shraddha RamchandaniHyderabad, IndiaContact: Shraddha RamchandaniNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Asian Institute of Gastroenterology, India
- Trial code
- NCT06102629
- Record updated
- 26 October 2023
- Original description
OBJECTIVES:Read full original descriptionShow less
Understanding the Epigenetic Mechanisms in the Pathophysiology of Polycystic Ovary Syndrome for Efficient Diagnosis and Targeted Therapy
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
Inclusion: All the subjects would be of Indian origin (controls ~100, cases ~100). They would be in their reproductive age (18-45 yrs). Rotterdam consensus would be used to diagnose PCOS and cases will be selected based on it; 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: Women with other causes of hyperandrogenism such as hyperprolactinemia, androgen-secreting tumors, Cushing syndrome and nonclassic congenital hyperplasia would be excluded from this study.