Vitamin D and Polycystic Ovarian Syndrome (PCOS)

Launched by AGA KHAN UNIVERSITY · Jun 17, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the effects of combining metformin, a medication commonly used to treat insulin resistance, with Vitamin D supplementation in women who have Polycystic Ovarian Syndrome (PCOS) and are struggling with infertility. The main goal is to see if this combination can improve insulin and hormone levels compared to using metformin alone. Researchers will also look at changes in the reproductive system, such as the thickness of the uterine lining and the size and number of ovarian follicles, by performing ultrasounds during the study.

To participate in this trial, women aged 18 to 36 years who have primary infertility due to PCOS and have low Vitamin D levels may be eligible. However, those with certain conditions such as secondary infertility, high calcium levels, or specific hormonal disorders will not be included. Participants can expect regular check-ups and tests to monitor their progress during the study. This research aims to find better treatment options for women dealing with infertility related to PCOS and Vitamin D deficiency.

Gender

ALL

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-fungal, statins, H2 blockers, immunosuppressants, chemotherapeutic agents, antimicrobials (Rifampicin, isoniazid, hydroqychloroquin) or any other drug modifying lipid metabolism in the previous 3 months prior to study
• • Women with congenital adrenal hyperplasia, Cushing's syndrome, androgen-secreting tumors, type 2 diabetes mellitus, renal, hepatic or thyroid disorders, hyperparathyroidism, malabsorption syndromes, Chronic Kidney Disease Hepatic failure, cystic fibrosis, vaginal bleeding of unknown etiology Women Those who had Bariatric surgery will also be excluded.