Polycystic ovary syndrome (PCOS)
Conditions
Interventions
A total 86 women age range between 18-45 years old diagnosed with PCOS according to Rotterdam criteria. Block randomization will be used to ensure that the total sample size of 86 will be equally divi
Sponsors
University of Peradeniya
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged between 18 to 45 years 2. Women who diagnosed with PCOS according to the Rotterdam criteria 3. Body Mass Index (BMI) equal or greater than 18 4. Willingness to sign the consent form
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactation mothers 2. Women who being under treatment for infertility or subfertility 3. Women who diagnosis of hyperprolactinemia, thyroid disorders, Cushing syndrome, adrenal hyperplasia, hypertension and Diabetes 4. Patients who were on any medication including oral contraceptive pills or over the counter medication and insulin-sensitizing agents or hormonal treatments involving estrogen, progesterone or any drug inducing insulin resistance within the past 3 months prior to the study enrolment. 5. Women with acute infections and illness 6. Unconsented patients 7. Patients diagnosed with psychiatric illnesses
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of menstrual cyclicity evidence by Proportion of resumption of normal menstrual cycle and menstrual frequency (number of menses/ month) The typical menstrual cycle pattern is 28 ± 7 days with menstrual flow lasting 4 ± 2 days and blood loss averaging 20 to 60 mL. Menstrual Cycle Patterns: will be assessed by cycle frequency, duration, regularity and volume. Frequency is defined as the interval between menstrual cycles, duration as the period from the beginning to the end of menstrual bleeding and regularity as variations of menstrual cycle length. [Day 1, 14, 21 , 2 months from visit 1 and final visit at 3 months from visit 1 ] Change in serum androgen level (total testosterone, SHBG and LH/FSH ratio) [ Day 1 and and final visit at 3 months from visit 1 ] Change in serum androgen level (total testosterone, SHBG and LH/FSH ratio) [ Day 1 and and final visit at 3 months from visit 1 ] | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in ovarian morphology and endometrial thickness evidence by the ultrasound scanning [Day 1, 14, 21 , 2 months from visit 1 and final visit at 3 months from visit 1 ] Change in insulin sensitivity indices, would be measured by homeostasis model assessment insulin-resistant (HOMA-IR) calculations based on fasting blood glucose and fasting serum insulin [ Day 1 and and final visit at 3 months from visit 1 ] Improvement of glycemic and metabolic indices evidenced by fasting blood sugar, OGTT, HbAIC and triglyceride and cholesterol (LDL, HDL, and total) [ Day 1 and and final visit at 3 months from visit 1 ] Change in circulatory hormones including FSH, LH, E2, P4, AMH, chemerin [ Day 1 and and final visit at 3 months from visit 1 ] Change in weight evidence by BMI and change in body fat distribution evidenced by, waist circumference (WC), hip circumference (HC), and waist/hip ratio. [ Day 1 and and final visit at 3 months from visit 1 ] Change in insulin sensitivity indices, would be measured by homeostasis model assessment insulin-resistant (HOMA-IR) calculations based on fasting blood glucose and fasting serum insulin [ Day 1 and and final visit at 3 months from visit 1 ] Improvement of glycemic and metabolic indices evidenced by fasting blood sugar, OGTT, HbAIC and triglyceride and cholesterol (LDL, HDL, and total) [ Day 1 and and final visit at 3 months from visit 1 ] Change in circulatory hormones including FSH, LH, E2, P4, AMH, chemerin [ Day 1 and and final visit at 3 months from visit 1 ] Change in weight evidence by BMI and change in body fat distribution evidenced by, waist circumference (WC), hip circumference (HC), and waist/hip ratio. [ Day 1 and and final visit at 3 months from visit 1 ] [Include safety outcome here] [ Respective time/period of assessment] | — |
Countries
Sri Lanka
Contacts
Public ContactM.C. Gihan
Senior Lecturer and Consultant Obstetrics and Gynaecology)
Outcome results
None listed