drugset / Trial / NCT05106712
Vitamin D Supplementation and Improvement of PCOS Therapy and IVF Outcomes in Infertile Saudi Women
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cholecalciferol | Other / unclassified | 4000 iu | Oral |
| Comparator | Clomiphene | Other / unclassified | 150 mg | Oral |
| Comparator | Letrozole | Other / unclassified | 7.5 mg | Oral |