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| Name | Class |
|---|---|
| All India Institute of Medical Sciences | OTHER |
| Nova IVI Fertility, New Delhi | UNKNOWN |
| Dr Patil's Fertility & Endoscopy Clinic, Bangalore | UNKNOWN |
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Objective: To assess effectiveness of ISD (Insulin sensitizing drugs) Vs OCP (Combined E&P cyproterone acetate) in improving clinical, hormonal and metabolic features of PCOS( polycystic ovary syndrome)women from India.
Intervention:
Randomized to receive Metformin 1500 mg / day OR OCP (EE+CA) Life style advice to women with BMI ( body mass index) more than 28 , in both groups (PS: progesterone can be added for getting withdrawal bleeding for amenorrhoea of more than two months, or for prolonged menstrual bleeding. ) Study period: 6 months Clinical evaluation points and tests at enrollment and again after 6 month. Clinical: BMI, Waist circumference, Hip circumference, Acne score, FG (modified Ferriman Gallwey score ) (after no epilation for last 6 weeks), Menstrual History Biochemical: Thyroid function tests, Prolactin,Total Testosterone, Lipid Profile, FAsting blood sugar & 75 gm 2 hr Glucose tolerance test (GTT), Sr Insulin, 25- hydroxy vitamin D (optional), (Only Radioimmunoassay / Chemiluminescence assays)
Acronyms: OCP(oral contraceptive pills); PCOS (polycystic ovary syndrome); FBS(fasting blood sugar); GTT(glucose tolerance test)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OCP | Active Comparator | Arm 1: oral contraceptive pill, combination pill of ethyl estradiol 20 micro gram with Cyproterone acetate. |
|
| Metformin | Active Comparator | Arm 2: Metformin . Oral insulin sensitising drug in the dose of 1500gms daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral contraceptive pill combination of ethyl estradiol and Cyproterone acetate | Drug |
| ||
| Metformin 1500mgs per day |
| Measure | Description | Time Frame |
|---|---|---|
| Improvements in Menstrual cycle in women with polycystic ovary syndrome. | To compare improvement in Menstrual cycle. Women will be required to maintain a menstrual calendar for the duration of the study and asked to fill a questionnaire before and after study duration.The questionnaire will cover menstrual cycle dates, duration and amount. Interpreting the answered will help in assessing improvement in menstrual pattern. | Six months |
| Improvement in hirsutism | FG scores before and after treatment will be compared between the two arms. Modified Ferriman and Gallwey visual score will be used by a nurse to assess before and after the study period. | six months |
| Improvement in acne score | Acne scores before and after treatment will be compared between the two arms. Visual assessment of acne using "mild/moderate/severe " grades will be assessed before and after study by a physician. | Six months |
| Weight loss following treatment | Weight loss will be compared between the two arms following 6 months of treatment | 6months |
| Reduction in total testosterones | Reduction in total testosterones, signifying biochemical hyperandrogenemia, will be compared between the two groups following 6 months treatment. | 6months |
| Reduction in serum fasting insulin | Reduction in insulin levels following treatment will be compared between the two arms | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sujata Kar, MD | Contact | 919437824163 | suju2463@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KAR clinic and hospital pvt ltd | Recruiting | Bhubaneswar | Odisha | 751001 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23531705 | Background | Kar S. Clomiphene citrate or letrozole as first-line ovulation induction drug in infertile PCOS women: A prospective randomized trial. J Hum Reprod Sci. 2012 Sep;5(3):262-5. doi: 10.4103/0974-1208.106338. | |
| 26752854 | Background | Kar S, Sanchita S. Clomiphene citrate, metformin or a combination of both as the first line ovulation induction drug for Asian Indian women with polycystic ovarian syndrome: A randomized controlled trial. J Hum Reprod Sci. 2015 Oct-Dec;8(4):197-201. doi: 10.4103/0974-1208.170373. |
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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 |
|---|---|
| D003276 | Contraceptives, Oral |
| D017373 | Cyproterone Acetate |
| ID | Term |
|---|---|
| D003271 | Contraceptive Agents, Female |
| D003270 | Contraceptive Agents |
| D012102 | Reproductive Control Agents |
| D045505 | Physiological Effects of Drugs |
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| Shreyas Hospital & Sushrut Assisted Conception Clinic, Kolhapur |
| UNKNOWN |
| University of Messina | OTHER |
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| Drug |
|
| Improvements in lipid profile |
Any improvement in triglycerides and HDLc (high density lipoprotein c) will be compared between the two groups after 6 months of treatment |
| 6months |
| Improvement in glucose tolerance | 75grams 2 hour glucose challenge test results will be compared pre and post treatment between the two groups | 6months |
| 23869152 | Background | Kumar P, Nawani N, Malhotra N, Malhotra J, Patil M, Jayakrishnan K, Kar S, Jirge PR, Mahajan N. Assisted reproduction in polycystic ovarian disease: A multicentric trial in India. J Hum Reprod Sci. 2013 Jan;6(1):49-53. doi: 10.4103/0974-1208.112382. |
| 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 |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045506 | Therapeutic Uses |
| D003534 | Cyproterone |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013258 | Steroids, Chlorinated |