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NCT03209856 Clinical Trial

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

Infertility Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03209856
Other study ID # 3645
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date July 6, 2017
Est. completion date April 20, 2021

Study information
Verified date October 2021
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 200
Est. completion date April 20, 2021
Est. primary completion date March 20, 2021
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 35 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Vitamin D
Vitamin D supplement will be given. Then, it will be maintained if pregnancy occurred

Locations
Country Name City State
Egypt Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital Cairo Greater Cairo

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical pregnancy rate This outcome will be calculated by a statistician It will be calculated 1 year after enrollment of the first patient in the study
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