Polycystic Ovary SyndromePCOS-01NCT06102629
Ovary Syndrome for Efficient Diagnosis and Targeted Therapy
A study testing laparoscopy / laparotomy in people with Polycystic Ovary Syndrome, run by Asian Institute of Gastroenterology, India at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- laparoscopy / laparotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIndia
- Study dates
- 5 Nov 2023to 15 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Women with other causes of hyperandrogenism such as hyperprolactinemia, androgen-secreting tumors, Cushing syndrome and nonclassic congenital hyperplasia would be excluded from this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Manjula Bhanoori contact
India1 site
Dr. Shraddha Ramchandani
Hyderabad, Telangana, 500082
Shraddha Ramchandani, 9182645727, drshraddhamohan@gmail.com
Manjula Bhanoori, bhanoorim@yahoo.co.in
About this study
Official title: Understanding the Epigenetic Mechanisms in the Pathophysiology of Polycystic Ovary Syndrome for Efficient Diagnosis and Targeted Therapy
OBJECTIVES:
- Analysis of DNA methyl transferases (DNMT1, DNMT3A and DNMT3B) and Histone deacetylases (HDAC 1,2,3 and SIRTs) polymorphisms (Somatic and germ line variations).
- Analysis of differential mRNA and protein expression of epigenetic markers in ovarian tissues obtained from PCOS patients.
- miRNA regulated epigenetic mechanisms in PCOS
- Epigenetic regulation of endocrine genes in PCOS
DESIGN : A Case Control study.Sample size:200
Read the detailed description
- 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.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- laparoscopy / laparotomy, NO INTERVENTION
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopy / laparotomyProcedure or surgery
- 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 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.
- Small tissue samples (from ovary) will be taken from the tissue which is surgically excised as a part of treatment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: laparoscopy / laparotomy; Other: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 YEARS
Secondary outcomes (1)
understand miRNA regulated epigenetic mechanisms
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).
Measured: 3 YEARS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start5 Nov 2023 (estimated)
- Primary completion15 Nov 2026 (estimated)
- Study completion15 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a Case control study with two parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shraddha Ramchandani, Principal investigator, AIG HOSPITALS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06102629
- Sponsor's protocol ID
- PCOS-01
- Acronym
- PCOS-01
- Status last verified
- Oct 2023
- First submitted
- 21 Oct 2023
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Epigenetic Mechanisms in the Pathophysiology of Polycystic Ovary Syndrome for Efficient Diagnosis and Targeted Therapy
- ClinicalTrials.gov ID
- NCT06102629
- Acronym / sponsor ID
- PCOS-01 / PCOS-01
- Conditions
- Polycystic Ovary Syndrome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 5 Nov 2023 (estimated)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OBJECTIVES:
- Analysis of DNA methyl transferases (DNMT1, DNMT3A and DNMT3B) and Histone deacetylases (HDAC 1,2,3 and SIRTs) polymorphisms (Somatic and germ line variations).
- Analysis of differential mRNA and protein expression of epigenetic markers in ovarian tissues obtained from PCOS patients.
- miRNA regulated epigenetic mechanisms in PCOS
- Epigenetic regulation of endocrine genes in PCOS
DESIGN : A Case Control study.Sample size:200
Detailed description
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a Case control study with two parallel groups
| Arm | Type | Receives |
|---|---|---|
| 100 women undergoing surgery (laparoscopy / laparotomy) with presumed diagnosis of PCOS ( | Experimental | Procedure: laparoscopy / laparotomy, Other: NO INTERVENTION1. 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 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Women with other causes of hyperandrogenism such as hyperprolactinemia, androgen-secreting tumors, Cushing syndrome and nonclassic congenital hyperplasia would be excluded from this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laparoscopy / laparotomy1. 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 or surgery | 100 women undergoing surgery (laparoscopy / laparotomy) with presumed diagnosis of PCOS ( |
| 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. | Other | 100 women undergoing surgery (laparoscopy / laparotomy) with presumed diagnosis of PCOS ( |
Primary outcome
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.
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.
1 secondary outcome
understand miRNA regulated epigenetic mechanisms
Time frame: 3 YEARS
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Manjula Bhanoori contact
Shraddha Ramchandani principal investigator
AIG HOSPITALS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopy / laparotomy in people with Polycystic Ovary Syndrome, run by Asian Institute of Gastroenterology, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shraddha Ramchandani (9182645727, drshraddhamohan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the Analysis of DNA methyl transferases (time frame: 3 YEARS). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2023.