NCT03989778

Vitamin D and Polycystic Ovarian Syndrome (PCOS)

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Aga Khan University · Academic / Other
• Sex: All
• Age: 18 Years – 36 Years
• Healthy volunteers: Accepted

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

Detailed description

Polycystic ovary syndrome (PCOS) as defined by "the presence of any two out of three criteria i.e. Oligo and/or anovulation, excess androgen activity and/or polycystic ovarian morphology on ultrasound", is a prevalent cause of female infertility. In the endocrine milieu of PCOS higher levels of insulin due to insulin resistance (IR) exert direct effects on the ovaries, release insulin-like growth factor 1 (IGF-1) from the liver and both then increase levels of testosterone. The resultant prevents the growth of ovarian follicles to acquire the required dimension for ovulation (i.e. \> 10 mm) hence leading to anovulation and therefore subfertility. Vitamin D (VD) has found to be predominantly deficient in PCOS females, documented to cause IR giving rise to anovulatory cycles, hyperandrogenism and other significant features of PCOS. Therefore, we have hypothesized that treatment with VD in PCOS females can reduce IR, improve ovulation and signs of hyperandrogenism. Since Metformin is frequently prescribed for reducing IR and hence the treatment for anovulatory infertility in these females, we have planned to conduct an open label randomized control trial in PCOS infertile females who have vitamin D levels \< than 25 ng/ml and are receiving Metformin therapy after ethical approval from Aga Khan University. The intervention group will receive VD Cholecalciferol (D2) 50,000 I.U once weekly for 12 weeks, followed by 50,000 I.U once every fortnight for 24 weeks with the Metformin treatment as prescribed by the physician whereas control group will receive Metformin treatment during the study period. We will compare change in number of dominant follicles (more than 10 mm) / endometrial thickness in both groups by Day 12 trans-vaginal ultrasound at the time of enrollment with scans done after 12 and 24 weeks. The other biochemical parameters \[Total Testosterone, Steroid Hormone Binding Globulin, Free Androgen Index, Lipid Accumulation Product, Serum Insulin, Serum Triglycerides, Serum Calcium and Albumin\] will be done at the time of recruitment in both the intervention and control groups and compared.

Conditions

• Infertility, Female
• Infertility
• Vitamin D Deficiency

Interventions

Type	Name	Description
DRUG	Vitamin D	Vitamin D supplementation

Timeline

• Start date: 2023-02-01
• Primary completion: 2025-06-30
• Completion: 2025-07-13
• First posted: 2019-06-18
• Last updated: 2025-02-19

Locations

2 sites across 1 country: Pakistan