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

• Status: Not yet recruiting
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Umm Al-Qura University
• Treatments: Cholecalciferol; Clomiphene; Enclomiphene; Letrozole; Vitamin D; Zuclomiphene

Criteria

Inclusion Criteria:

1. Women aged 20 to 42 years old;

2. Diagnosed with PCOS (Rotterdam Criteria);

3. Written informed consent.

Exclusion Criteria:

1. Non-PCOS Infertile patients, e.g, who have Cushing's syndrome, congenital adrenal hyperplasia, androgen-secreting tumors, hyperprolactinemia.

2. PCOS patients who are underwent any anti-infertility treatments.

3. PCOS patients who had receiving any vitamin D supplement or any multivitamin supplement within the past 3 month prior to enrollment process.

4. PCOS patients with established diagnosis of diabetes mellitus, chronic liver, kidney, or thyroid diseases.

5. PCOS patients receiving any treatment affect the metabolism of vitamin D.

6. Any supplements that contain vitamin D within the past month.