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

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

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.

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Drug: Vitamin D

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 Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Greater Cairo
    • Cairo, Greater Cairo, Egypt, 11956
      • Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2017
• Primary Completion (Actual): March 20, 2021
• Study Completion (Actual): April 20, 2021

Study Registration Dates

• First Submitted: July 4, 2017
• First Submitted That Met QC Criteria: July 4, 2017
• First Posted (Actual): July 6, 2017

Study Record Updates

• Last Update Posted (Actual): October 6, 2021
• Last Update Submitted That Met QC Criteria: October 5, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Micronutrients; Membrane Transport Modulators; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vasoconstrictor Agents; Calcium Channel Agonists; Vitamin D; Calcitriol
• Other Study ID Numbers: 3645

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No