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Trial Title:
Ovary Syndrome for Efficient Diagnosis and Targeted Therapy
NCT ID:
NCT06102629
Condition:
Polycystic Ovary Syndrome
Conditions: Official terms:
Polycystic Ovary Syndrome
Syndrome
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
This is a Case control study with two parallel groups
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
laparoscopy / laparotomy
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.
Arm group label:
100 women undergoing surgery (laparoscopy / laparotomy) with presumed diagnosis of PCOS (
Intervention type:
Other
Intervention name:
NO INTERVENTION
Description:
.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.
Arm group label:
100 women undergoing surgery (laparoscopy / laparotomy) with presumed diagnosis of PCOS (
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
45 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Dr. Shraddha Ramchandani
Address:
City:
Hyderabad
Zip:
500082
Country:
India
Contact:
Last name:
Shraddha Ramchandani
Phone:
9182645727
Email:
drshraddhamohan@gmail.com
Contact backup:
Last name:
Manjula Bhanoori
Email:
bhanoorim@yahoo.co.in
Start date:
November 5, 2023
Completion date:
November 15, 2026
Lead sponsor:
Agency:
Asian Institute of Gastroenterology, India
Agency class:
Other
Source:
Asian Institute of Gastroenterology, India
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06102629
