- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01348594
The Impact of Vitamin D Status on in Vitro Fertilization (IVF) Outcomes
June 18, 2012 updated by: Kimberly Liu, University of Toronto
The Impact of Vitamin D on Implantation and Clinical Pregnancy Rates Following in Vitro Fertilization
Infertility is a common and psychologically devastating problem for 20% of Canadian couples.
Approximately, 20% of infertile couples are diagnosed with unexplained infertility and left without an explanation for their inability to have a baby.
Pathological uterine receptivity and embryo implantation are hypothesized mechanisms underlying sub-fertility in these couples.
Embryo implantation requires a complicated sequence of events involving the differentiation of endometrial cells to attain uterine receptivity and the synchronized interaction between maternal and embryonic tissues.
Vitamin D has been hypothesized to play a role in this poorly understood process.
Vitamin D is a known regulator of signal transduction pathways involved in embryo implantation and its receptors are involved in calcium-regulation in various reproductive tissues including, the ovary, uterus, and placenta.
In Canada, the prevalence of Vitamin D insufficiency is approximately 34-50%.
The goal of the proposed study is to determine the prevalence of vitamin D insufficiency in an infertile population and whether this prevalence is higher than in average Canadian reproductive age women.
More importantly, we will investigate whether vitamin D insufficiency in our infertile population translates to impaired implantation and reduced clinical pregnancy rates.
Insight into vitamin D's role in reproduction is essential not only to provide scientific understanding of the mechanism underlying embryo implantation, but also because vitamin D supplementation could provide an easy and safe means of treating infertility.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
182
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Toronto, Ontario, Canada, m5t2z5
- Centre for Fertility and Reproductive Health, Mount Sinai Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Patients undergoing IVF at Mount Sinai Hospital
Description
Inclusion Criteria:
- Age > 18, < 40
- Day 3 FSH < 10
- Capable of providing informed consent
Exclusion Criteria:
- BMI > 35
- Untreated uterine pathology ie. fibroids, septum, polyps
- Unable to provide informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Vitamin D deficient
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Vitamin D sufficient
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
implantation rates following IVF
Time Frame: 3 weeks
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3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
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clinical pregnancy rates following IVF
Time Frame: 3 weeks
|
3 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kimberly Liu, MD FRCSC, Mount Sinai Hospital, University of Toronto
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2011
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
June 1, 2012
Study Registration Dates
First Submitted
May 4, 2011
First Submitted That Met QC Criteria
May 4, 2011
First Posted (Estimate)
May 5, 2011
Study Record Updates
Last Update Posted (Estimate)
June 19, 2012
Last Update Submitted That Met QC Criteria
June 18, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 10-0288-E
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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