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OBJECTIVES:
DESIGN : A Case Control study.Sample size:200
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 100 women undergoing surgery (laparoscopy / laparotomy) with presumed diagnosis of PCOS ( | Experimental |
|
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| 100 women undergoing surgery for gynaecological disorder | No Intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laparoscopy / laparotomy | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 3 YEARS |
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Inclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shraddha Ramchandani | Contact | 9182645727 | drshraddhamohan@gmail.com | |
| Manjula Bhanoori | Contact | bhanoorim@yahoo.co.in |
| Name | Affiliation | Role |
|---|---|---|
| Shraddha Ramchandani | AIG HOSPITALS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Shraddha Ramchandani | Hyderabad | Telangana | 500082 | India |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| ID | Term |
|---|---|
| D010535 | Laparoscopy |
| D007813 | Laparotomy |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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This is a Case control study with two parallel groups
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| 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. 3. Small tissue samples (from ovary) will be taken from the tissue which is surgically excised as a part of treatment. |
|
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |