Status:
NOT_YET_RECRUITING
Ovary Syndrome for Efficient Diagnosis and Targeted Therapy
Lead Sponsor:
Asian Institute of Gastroenterology, India
Conditions:
Polycystic Ovary Syndrome
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief Summary
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 differen...
Detailed Description
1. 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 (...
Eligibility Criteria
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.
Key Trial Info
Start Date :
November 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 15 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06102629
Start Date
November 5 2023
End Date
November 15 2026
Last Update
October 26 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Dr. Shraddha Ramchandani
Hyderabad, Telangana, India, 500082