Polycystic Ovary Syndrome
Conditions
Keywords
PCOS, Metformin, OCP, metabolic parameters
Brief summary
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)
Interventions
DRUGOral contraceptive pill combination of ethyl estradiol and Cyproterone acetate
DRUGMetformin 1500mgs per day
Sponsors
All India Institute of Medical Sciences
Nova IVI Fertility, New Delhi
Dr Patil's Fertility & Endoscopy Clinic, Bangalore
Shreyas Hospital & Sushrut Assisted Conception Clinic, Kolhapur
University of Messina
Kar Clinic & Hospital Pvt. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* PCOS Women diagnosed by Rotterdam criteria * Age \> 16 or menarche of at least 2 yr upto age 40. * Diagnosed by Rotterdam Anovulation F.G. Score ≥ 8 or Total testosterone ≥ 40 ngms/dl ovarian volume ≥ 10 cc BMI\>23 * Women not attempting pregnancy at present.
Exclusion criteria
* PCOS Women with BMI ≤ 23 * Undergoing any treatment for acne hirsutism. Including Homeopathic, Ayurvedic * Known diabetic or hypertension .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvements in Menstrual cycle in women with polycystic ovary syndrome. | Six months | 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. |
| Improvement in hirsutism | six months | 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. |
| Improvement in acne score | Six months | 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. |
| Weight loss following treatment | 6months | Weight loss will be compared between the two arms following 6 months of treatment |
| Reduction in total testosterones | 6months | Reduction in total testosterones, signifying biochemical hyperandrogenemia, will be compared between the two groups following 6 months treatment. |
| Reduction in serum fasting insulin | 6 months | Reduction in insulin levels following treatment will be compared between the two arms |
| Improvements in lipid profile | 6months | Any improvement in triglycerides and HDLc (high density lipoprotein c) will be compared between the two groups after 6 months of treatment |
| Improvement in glucose tolerance | 6months | 75grams 2 hour glucose challenge test results will be compared pre and post treatment between the two groups |
Countries
India
Contacts
Primary ContactSujata Kar, MD
Outcome results
None listed