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Vitamin D Supplementation in Vitamin Deficient Women Undergoing IVF Cycles: Does it Affect the Fertility Outcome?

Phase 4
Completed
Conditions
Infertility
Interventions
Registration Number
NCT03209856
Lead Sponsor
Cairo University
Brief Summary

The aim of this study is to evaluate the effect of treatment of vitamin D deficiency (through vitamin D supplementation for 8 weeks before the start of In-vitro fertilization (IVF) on the success of IVF cycles.

Detailed Description

The study participants are vitamin D deficient females undergoing (intra-cytoplasmic sperm injection (ICSI) trial in the age of 20 to 35 years. Serum vitamin D will be assessed. Accordingly, if they are deficient in vitamin D, they will be eligible for the study.400 vitamin D deficient women will be randomly allocated to either one of two groups. The first group will receive vitamin D supplementation in addition to the routine care. The other group will receive the routine care only. The study will be conducted in the IVF unit of department of Obstetrics and Gynecology, Cairo University.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
200
Inclusion Criteria
  • Vitamin D deficient females undergoing first ICSI trial
  • Age from 20 to 35 years
Exclusion Criteria
  • Women undergoing ICSI trials who are vitamin D sufficient

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Vitamin D supplementVitamin DThis group will receive weekly oral 50000 international units of vitamin D supplement for 8 weeks before the start of ICSI cycle. In addition, the routine care will be given.
Primary Outcome Measures
NameTimeMethod
Clinical pregnancy rateIt will be calculated 1 year after enrollment of the first patient in the study

This outcome will be calculated by a statistician

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital

🇪🇬

Cairo, Greater Cairo, Egypt

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