NCT06102629Not yet recruiting
Ovary Syndrome for Efficient Diagnosis and Targeted Therapy
Understanding the Epigenetic Mechanisms in the Pathophysiology of Polycystic Ovary Syndrome for Efficient Diagnosis and Targeted Therapy
Source: ClinicalTrials.gov · Last updated 26 Oct 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 21 Oct 2023
- Start date
- 5 Nov 2023
- Primary completion date
- 15 Nov 2026
- Lead sponsor
- Asian Institute of Gastroenterology, India
- NCT number
- NCT06102629
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 5 Nov 2023 to the primary completion date, 15 Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Women with other causes of hyperandrogenism such as hyperprolactinemia, androgen-secreting tumors, Cushing syndrome and nonclassic congenital hyperplasia would be excluded from this study.
Who the study is looking for
- 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.
Age in the registry: 18 years to 45 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dr. Shraddha Ramchandani Coordinator of this site? Confirm its status | Hyderabad | India | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.