Ovary Syndrome for Efficient Diagnosis and Targeted Therapy (PCOS-01)

October 25, 2023 updated by: Asian Institute of Gastroenterology, India

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 100 women undergoing surgery (laparoscopy / laparotomy) with presumed diagnosis of PCOS (
  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.
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.
No Intervention: 100 women undergoing surgery for gynaecological disorder
  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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the Analysis of DNA methyl transferases
Time Frame: 3 YEARS
DNA will be extracted as per the protocol followed routinely in our lab from blood and ovarian tissues.
3 YEARS
Evaluate the Analysis of differential mRNA and protein expression of epigenetic markers in ovarian tissues
Time Frame: 3 YEARS
Total RNA from ovarian tissue will be extracted using TRIzol reagent according to the manufacturer's instructions (Invitrogen Life Technologies) and reverse transcribed in the presence of random hexamers. Quantitative real-time PCR reactions will be carried out in an ABI 7000 Thermal Cycler (Applied Biosystems) to analyse the expression of epigenetic markers including the androgen regulated miRNAs and their downstream targets.
3 YEARS

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
understand miRNA regulated epigenetic mechanisms
Time Frame: 3 YEARS
The present study would investigate the expression pattern of DNMTs, HDACs, miRNAs and their downstream targets in Ovarian tissues (samples of normal adult ovaries and polycystic ovaries) by western blot and immunohistochemical analysis (IHC).
3 YEARS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asian Institute of Gastroenterology, India

Investigators

  • Principal Investigator: Shraddha Ramchandani, AIG Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 5, 2023

Primary Completion (Estimated)

November 15, 2026

Study Completion (Estimated)

November 15, 2026

Study Registration Dates

First Submitted

October 21, 2023

First Submitted That Met QC Criteria

October 25, 2023

First Posted (Actual)

October 26, 2023

Study Record Updates

Last Update Posted (Actual)

October 26, 2023

Last Update Submitted That Met QC Criteria

October 25, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCOS-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Polycystic Ovary Syndrome

Clinical Trials on laparoscopy / laparotomy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Austria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe