drugset / Trial / NCT05106712

Vitamin D Supplementation and Improvement of PCOS Therapy and IVF Outcomes in Infertile Saudi Women

NCT05106712

Unknown 700 enrolled Umm Al-Qura University
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This randomized double-blinded-controlled clinical trial consists of two protocols as follow: protocol 1: evaluation of the therapeutic effects of Vitamin D3 supplement when given alone and in combination with an ovulation-inducing agent (e.g., Clomiphene citrate or Letrozole) on ovarian functional status and hormonal and metabolic features of PCOS-Vitamin D-deficient infertile Saudi women; and protocol 2: evaluation of the effectiveness of Vitamin D3 supplement versus placebo on the clinical pregnancy rate, fertilization implantation rate, live birth rate, and other outcome parameters following in-vitro fertilization (IVF) application in these PCOS-Vitamin D-deficient infertile patients.

Timeline

Start
2021-11-01
Primary completion
2023-07-01
Completion
2023-11-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Cholecalciferol Other / unclassified 4000 iu Oral
Comparator Clomiphene Other / unclassified 150 mg Oral
Comparator Letrozole Other / unclassified 7.5 mg Oral