Back to resultsVitamin D Supplementation in Vitamin Deficient Women Undergoing IVF Cycles: Does it Affect the Fertility Outcome?
Primary Purpose
Infertility
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Vitamin D
Sponsored by
About this trial
This is an interventional treatment trial for Infertility
Eligibility Criteria
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
Sites / Locations
- Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Vitamin D supplement
Routine care
Arm Description
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.
This group will receive the routine care.
Outcomes
Primary Outcome Measures
Clinical pregnancy rate
This outcome will be calculated by a statistician
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03209856
Brief Title
Vitamin D Supplementation in Vitamin Deficient Women Undergoing IVF Cycles: Does it Affect the Fertility Outcome?
Official Title
Vitamin D Supplementation in Vitamin Deficient Women Undergoing ICSI Cycles: Does it Affect the Fertility Outcome?
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
July 6, 2017 (Actual)
Primary Completion Date
March 20, 2021 (Actual)
Study Completion Date
April 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D supplement
Arm Type
Experimental
Arm Description
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.
Arm Title
Routine care
Arm Type
No Intervention
Arm Description
This group will receive the routine care.
Intervention Type
Drug
Intervention Name(s)
Vitamin D
Other Intervention Name(s)
Calcitriol
Intervention Description
Vitamin D supplement will be given. Then, it will be maintained if pregnancy occurred
Primary Outcome Measure Information:
Title
Clinical pregnancy rate
Description
This outcome will be calculated by a statistician
Time Frame
It will be calculated 1 year after enrollment of the first patient in the study
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eman Omran, M.D.
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital
City
Cairo
State/Province
Greater Cairo
ZIP/Postal Code
11956
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Vitamin D Supplementation in Vitamin Deficient Women Undergoing IVF Cycles: Does it Affect the Fertility Outcome?
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