Combination of Vitamin D Plus Probiotic Affects Hormonal, and Inflammatory Markers in Women with Polycystic Ovary Syndrome Undergoing In Vitro Fertilization: A Randomized Double Blind Clinical Trial.

Abstract

Background: This study aimed to evaluate the effects of vitamin D and probiotic supplements on anti-Mullerian hormone (AMH), glycemic control, inflammatory markers, and in vitro fertilization (IVF) success in women with polycystic ovary syndrome (PCOS).

Materials and methods: A randomized, double-blind, placebo-controlled trial was conducted with 120 women aged 30-45 years, diagnosed with PCOS and undergoing IVF. Participants were divided into four groups (30 each): daily 4,000 IU vitamin D, probiotic (1.8×10⁹ CFU/capsule), a combination of both, or placebo for 8 weeks.

Results: After 8 weeks, the combination group showed significant reductions in insulin levels (-0.33 ± 0.37 vs. -0.14 ± 0.29, -0.11 ± 0.04, -0.02 ± 0.36 μIU/mL, P=0.020), insulin resistance (-0.07 ± 0.09 vs. -0.03 ± 0.07, -0.03 ± 0.09, -0.07 ± 0.09, P=0.024), and increased insulin sensitivity (+0.001 ± 0.001 vs. +0.0006 ± 0.001, +0.0005 ± 0.002, +0.00004 ± 0.001, P=0.034) compared to other groups. The combination also led to a significant reduction in high-sensitivity C-reactive protein (hs-CRP) levels (-0.18 ± 0.22 vs. -0.07 ± 0.17, -0.08 ± 0.15, +0.04 ± 0.18, P=0.001). No significant changes were observed in plasma total nitrite, fasting glucose, and AMH levels. There was a notable decrease in TNF-α gene activity (P=0.007) in peripheral blood mononuclear cells (PBMCs) in the combination group.

Conclusion: The combined supplementation of vitamin D and probiotics over 8 weeks improved insulin function, hs-CRP levels, and TNF-α gene expression in women with PCOS undergoing IVF. However, it did not significantly impact plasma total nitrite, fasting glucose, or AMH levels (registration number: IRCT20130211012438N34).