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

Vitamin D Status Clinical Trial

Official title:

The Impact of Vitamin D on Implantation and Clinical Pregnancy Rates Following in Vitro Fertilization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01348594
• Other study ID #: 10-0288-E
• 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

• Vitamin D Status

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