The Impact of Vitamin D Status on in Vitro Fertilization (IVF) Outcomes

Completed

• Conditions: Vitamin D Status

• Registration Number: NCT01348594
• Lead Sponsor: University of Toronto

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-05-04
• Study First Submitted QC: 2011-05-04
• Study First Posted: 2011-05-05
• Primary Completion: 2011-12
• Status Verified: 2012-06
• Study Completion: 2012-06
• Last Update Submitted: 2012-06-18
• Last Update Posted: 2012-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 182

Inclusion Criteria

• Age > 18, < 40
• Day 3 FSH < 10
• Capable of providing informed consent

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Exclusion Criteria

• BMI > 35
• Untreated uterine pathology ie. fibroids, septum, polyps
• Unable to provide informed consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
implantation rates following IVF	3 weeks

Secondary Outcome Measures

Name	Time	Method
clinical pregnancy rates following IVF	3 weeks

Trial Locations

Locations (1)

Centre for Fertility and Reproductive Health, Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada