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

NCT05106712 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2021-11-04

No results posted yet for this study

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.

Conditions

  • Female Infertility
  • Polycystic Ovary Syndrome
  • Pathologic Processes
  • Vitamin D Deficiency
  • IVF
  • Vitamin D Supplement

Interventions

DRUG

Vitamin D3

4000IU per day for around 12 weeks.

DRUG

Clomiphene Citrate

oral Clomiphene citrate using its respective "Stair-step dosage protocol" as follow: 50 mg, 100 mg, and 150 mg, once daily for 5 days, in the 1st, 2nd, and 3rd cycle, respectively.

DRUG

Letrozole

oral Letrozole using its respective "Stair-step dosage protocol" as follow: 5 mg, 5 mg, and 7.5 mg, once daily for 5 days, in the 1st, 2nd, and 3rd cycle, respectively, respectively.

OTHER

placebo

participants in the control (Placebo) group will be treated with equal amount of placebo tablets per day for the same duration

Sponsors & Collaborators

  • Umm Al-Qura University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
42 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

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

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05106712 on ClinicalTrials.gov