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Recruiting Phase 2 NCT03989778

Vitamin D and Polycystic Ovarian Syndrome (PCOS)

Trial Parameters

Condition Infertility, Female
Sponsor Aga Khan University
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 300
Sex ALL
Min Age 18 Years
Max Age 36 Years
Start Date 2023-02-01
Completion 2025-06-30
Interventions
Vitamin D

Brief Summary

Primary Objectives: To evaluate the efficacy of metformin and Vitamin D supplementation on serum insulin and serum androgen levels (Total testosterone, Steroid Hormone Binding Globulin, Free Androgen Index) levels compared metformin alone in infertile Poly cystic ovarian females of reproductive age group. Secondary Objectives: To measure change in endometrial thickness/number of follicles and follicular size by day 12 trans-vaginal ultrasound in the intervention group i.e. combination of metformin and vitamin D supplementation

Eligibility Criteria

Inclusion Criteria: * Females with age range 18- 36 years, from all ethnic background having primary infertility with diagnosis of PCOS when at least 2 of these 3 elements are present: hyperandrogenism, chronic anovulation and polycystic ovaries and Vitamin D deficiency serum levels \< 25 nmol/L Exclusion Criteria: exclusion criteria at baseline will be excluded from the study * Females with secondary Infertility * Hypercalcemia (plasma calcium concentrations\> 2.65 mmol/L) * Exclude women with Tuberculosis or other granulomatous disorders. * Women receiving vitamin D replacement, oral contraceptives, hormonal replacement therapy, glucocorticoids, calcium supplementation, insulin-sensitizing drugs(incretin mimetic drugs, thiazolidinedione, sulfonylurea), lipid-lowering drugs or other drugs affecting insulin sensitivity or serum androgens (e.g., niacin, corticosteroids, beta-blockers, calcium channel blockers, thiazide diuretics), anti-epileptics, anti-retroviral, cholestyramine, anti-f

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