Clinical trial NCT06102629: Ovary Syndrome for Efficient Diagnosis and Targeted Therapy
Official title: Understanding the Epigenetic Mechanisms in the Pathophysiology of Polycystic Ovary Syndrome for Efficient Diagnosis and Targeted Therapy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Asian Institute of Gastroenterology, India
Sponsor class: OTHER
First posted: 2023-10-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a Case control study with two parallel groups
Primary purpose: TREATMENT

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 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

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 (surgical profile) before their planned surgery or for disease evaluation.
3. Small tissue samples (from ovary) will be taken from the tissue which is surgically excised as a part of treatment.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* Women with other causes of hyperandrogenism such as hyperprolactinemia, androgen-secreting tumors, Cushing syndrome and nonclassic congenital hyperplasia would be excluded from this study.

Primary outcomes:
measure: Evaluate the Analysis of DNA methyl transferases
timeFrame: 3 YEARS
measure: Evaluate the Analysis of differential mRNA and protein expression of epigenetic markers in ovarian tissues
timeFrame: 3 YEARS
Secondary outcomes:
measure: understand miRNA regulated epigenetic mechanisms
timeFrame: 3 YEARS
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Dr. Shraddha Ramchandani
state: Telangana
Study officials:
affiliation: AIG HOSPITALS
name: Shraddha Ramchandani
role: PRINCIPAL_INVESTIGATOR
References: