Objective: to determine the effect of vitamin D (VD) supplementation on ICSI outcome in vitamin D deficient females. Methods: A randomized controlled trial was done in IVF unit of Cairo University from July 2017 to Mach 2021. Level of VD was measured (females with level below 30 ng/ml were eligible). 400 VD deficient (or insufficient) females randomly allocated to 2 groups; VD supplementation (group 1) and non-supplemented group (group 2). Outcome data were analyzed for 187 participants in group 1 and for 186 in group 2. Regression analysis was done to calculate the Odds ratio (OR) for the primary outcome (clinical pregnancy rate, CPR) adjusting for confounders (age, BMI, type and cause of infertility). The study secondary outcome were the fertilization and the implantation rates. Results: Group 1 had higher fertilization (86% vs 64%, difference of 18%; 95%CI; 14%, 21%, p<0.01) and implantation rates (27% vs 17%, difference 10%; 95%CI 4%, 16%, p<0.01). CPR was higher in group1 (83/187, 44% vs 63/186, 34%, difference of 10%, 95%CI; 1%, 20%; p=0.03). After adjustment, the Odds ratio for pregnancy in group 1 was 2.1 (95%CI: 2.1, 3.3, p=0.01), Conclusion: VD supplementation increases the clinical pregnancy, fertilization and implantation rates in ICSI cycles.
ClinicalTrial.gov Registration number: NCT03209856.