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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01348594
Other study ID # 10-0288-E
Secondary ID
Status Completed
Phase N/A
First received May 4, 2011
Last updated June 18, 2012
Start date April 2011
Est. completion date June 2012

Study information

Verified date June 2012
Source University of Toronto
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 182
Est. completion date June 2012
Est. primary completion date December 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Canada Centre for Fertility and Reproductive Health, Mount Sinai Hospital Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary implantation rates following IVF 3 weeks No
Secondary clinical pregnancy rates following IVF 3 weeks No
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