Ovary Syndrome for Efficient Diagnosis and Targeted Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: laparoscopy / laparotomy, NO INTERVENTION.
- Who it may be relevant to
- Registry conditions: Polycystic Ovary Syndrome. Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- India
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Understanding the Epigenetic Mechanisms in the Pathophysiology of Polycystic Ovary Syndrome for Efficient Diagnosis and Targeted Therapy
Overview
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.
Interventions
- Procedure laparoscopy / laparotomy
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. - Other NO INTERVENTION
.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.
Primary outcome measures
- Evaluate the Analysis of DNA methyl transferases [Time frame: 3 YEARS]
- Evaluate the Analysis of differential mRNA and protein expression of epigenetic markers in ovarian tissues [Time frame: 3 YEARS]
Secondary outcome measures (1)
- understand miRNA regulated epigenetic mechanisms [Time frame: 3 YEARS]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
India · 1 center
- Dr. Shraddha Ramchandani — Hyderabad
Identifiers
NCT: NCT06102629 · PCOS-01