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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03209856
Recruitment Status : Completed
First Posted : July 6, 2017
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Eman Omran, 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.

Condition or disease Intervention/treatment Phase
Infertility 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.

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Study Type : Interventional  (Clinical Trial)
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 : July 6, 2017
Actual Primary Completion Date : November 20, 2019
Actual Study Completion Date : December 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

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 Name: Calcitriol

No Intervention: Routine care
This group will receive the routine care.



Primary Outcome Measures :
  1. Clinical pregnancy rate [ Time Frame: It 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 :
  1. Positive pregnancy rate [ Time Frame: It will be calculated 1 year after enrollment of the first patient in the study ]
    This outcome will be calculated by a statistician

  2. Fertilization rate [ Time Frame: It will be calculated 1 year after enrollment of the first patient in the study ]
    This outcome will be calculated by a statistician

  3. Implantation rate [ Time Frame: It will be calculated 1 year after enrollment of the first patient in the study ]
    This outcome will be calculated by a statistician



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Vitamin D deficient females undergoing first ICSI trial
  • Age from 20 to 35 years

Exclusion Criteria:

  • Women undergoing ICSI trials whose serum vitamin D level more than 20 nano-gram per milliliter

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03209856


Locations
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Egypt
Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital
Cairo, Greater Cairo, Egypt, 11956
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Eman Omran, M.D. Cairo University
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Responsible Party: Eman Omran, Principal investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03209856    
Other Study ID Numbers: 3645
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infertility
Vitamin D
Calcitriol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents