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

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT03209856
Collaborator
(none)
200
1
2
45.5
4.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Vitamin D
Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Vitamin D Supplementation in Vitamin Deficient Women Undergoing ICSI Cycles: Does it Affect the Fertility Outcome?
Actual Study Start Date :
Jul 6, 2017
Actual Primary Completion Date :
Mar 20, 2021
Actual Study Completion Date :
Apr 20, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Vitamin D supplement

This 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.

Drug: Vitamin D
Vitamin D supplement will be given. Then, it will be maintained if pregnancy occurred
Other Names:
  • Calcitriol
  • No Intervention: Routine care

    This group will receive the routine care.

    Outcome Measures

    Primary Outcome Measures

    1. Clinical pregnancy rate [It will be calculated 1 year after enrollment of the first patient in the study]

      This outcome will be calculated by a statistician

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital Cairo Greater Cairo Egypt 11956

    Sponsors and Collaborators

    • Cairo University

    Investigators

    • Principal Investigator: Eman Omran, M.D., Cairo University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eman Omran, Principal investigator, Cairo University
    ClinicalTrials.gov Identifier:
    NCT03209856
    Other Study ID Numbers:
    • 3645
    First Posted:
    Jul 6, 2017
    Last Update Posted:
    Oct 6, 2021
    Last Verified:
    Oct 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 6, 2021