NCT06102629

Brief Summary

OBJECTIVES:

  1. 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. 2.Analysis of differential mRNA and protein expression of epigenetic markers in ovarian tissues obtained from PCOS patients.
  3. 3.miRNA regulated epigenetic mechanisms in PCOS
  4. 4.Epigenetic regulation of endocrine genes in PCOS

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
5mo left

Started Nov 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Nov 2023Nov 2026

First Submitted

Initial submission to the registry

October 21, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 26, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

November 5, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2026

Last Updated

October 26, 2023

Status Verified

October 1, 2023

Enrollment Period

3 years

First QC Date

October 21, 2023

Last Update Submit

October 25, 2023

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (2)

  • Evaluate the Analysis of DNA methyl transferases

    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

    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 Outcomes (1)

  • understand miRNA regulated epigenetic mechanisms

    3 YEARS

Study Arms (2)

100 women undergoing surgery (laparoscopy / laparotomy) with presumed diagnosis of PCOS (

EXPERIMENTAL

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 / laparotomyOther: NO INTERVENTION

100 women undergoing surgery for gynaecological disorder

NO INTERVENTION

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

laparoscopy / laparotomyPROCEDURE

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.

100 women undergoing surgery (laparoscopy / laparotomy) with presumed diagnosis of PCOS (
NO INTERVENTIONOTHER

.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.

100 women undergoing surgery (laparoscopy / laparotomy) with presumed diagnosis of PCOS (

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Shraddha Ramchandani

Hyderabad, Telangana, 500082, India

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

LaparoscopyLaparotomy

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Shraddha Ramchandani

    AIG HOSPITALS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shraddha Ramchandani

CONTACT

9182645727drshraddhamohan@gmail.com

Manjula Bhanoori

CONTACT

bhanoorim@yahoo.co.in

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a Case control study with two parallel groups
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2023

First Posted

October 26, 2023

Study Start

November 5, 2023

Primary Completion (Estimated)

November 15, 2026

Study Completion (Estimated)

November 15, 2026

Last Updated

October 26, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)