Effects of Vitamin D on PCOS-related infertility

Efficacy of Vitamin D Supplementation and Metformin Compared to Metformin Alone for Improvement in Follicle Size of Infertile Females With Polycystic Ovary Syndrome: a Randomized Open Label Trial

This study is testing if adding Vitamin D to metformin can help women with PCOS who are struggling to get pregnant by improving their hormone levels and ovulation.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years to 36 Years
• Sex: All
• Sponsor: Aga Khan University (Academic / other)
• Locations: 2 sites (Karachi, Sindh and 1 other locations)
• Trial ID: NCT03989778 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of combining metformin with Vitamin D supplementation in improving insulin and androgen levels in women with Polycystic Ovarian Syndrome (PCOS) who are experiencing infertility. The study aims to determine if this combination can enhance ovulation and reduce symptoms associated with hyperandrogenism. Participants will receive Vitamin D Cholecalciferol weekly for 12 weeks, followed by bi-weekly doses for an additional 24 weeks, alongside their metformin therapy. The trial will also assess changes in endometrial thickness and follicular development through trans-vaginal ultrasound.

Who should consider this trial

Good fit: Ideal candidates are women aged 18-36 with primary infertility due to PCOS and Vitamin D levels below 25 nmol/L.

Not a fit: Patients with secondary infertility or those on medications affecting insulin sensitivity or androgen levels may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve fertility outcomes for women with PCOS and Vitamin D deficiency.

How similar studies have performed: Previous studies have shown promising results with Vitamin D supplementation in improving PCOS symptoms, but this specific combination approach is less commonly tested.

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.

Where this trial is running

Karachi, Sindh and 1 other locations

• Dr Rehana Rehman — Karachi, Sindh, Pakistan (Recruiting)
• Dr Rehana Rehman — Karachi, Sindh, Pakistan (Recruiting)

Study contacts

• Study coordinator: Rehana K Rehman, PhD

Conditions Infertility, Female; Infertility; Vitamin D Deficiency