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NCT Number: NCT06102629

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

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

  • We will take both blood and ovarian tissue samples used to diagnosis.
  • 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.
  • Small tissue samples (from ovary) will be taken from the tissue which is surgically excised as a part of treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

laparoscopy / laparotomy

Procedure
  • We will take both blood and ovarian tissue samples used to diagnosis.
  • 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.
  • Small tissue samples (from ovary) will be taken from the tissue which is surgically excised as a part of treatment.

No intervention

Other

.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.

  • Small tissue samples (from ovary) will be taken from the tissue which is surgically excised as a part of treatment.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Manjula Bhanoori

CONTACT

[email protected]

Shraddha Ramchandani

CONTACT

[email protected]

9182645727

Sponsors and collaborators

Lead sponsor

Asian Institute of Gastroenterology, India

Other

Registry information

Official study title

Understanding the Epigenetic Mechanisms in the Pathophysiology of Polycystic Ovary Syndrome for Efficient Diagnosis and Targeted Therapy

Acronym: PCOS-01

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 26, 2023
Registry last updated
Oct 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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