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

NCT01348594 | Completed

• 1 other identifier: 10-0288-E
• Study Type: observational
• Target: 182
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Status

Keywords

Vitamin D; In vitro Fertilization

Outcome Measures

Primary Outcomes (1)

• implantation rates following IVF

  3 weeks

Secondary Outcomes (1)

• clinical pregnancy rates following IVF

  3 weeks

Study Arms (2)

Vitamin D deficient

Vitamin D sufficient

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing IVF at Mount Sinai Hospital

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Toronto: lead

Study Sites (1)

Centre for Fertility and Reproductive Health, Mount Sinai Hospital

Toronto, Ontario, m5t2z5, Canada

Location

Related Publications (1)

• Garbedian K, Boggild M, Moody J, Liu KE. Effect of vitamin D status on clinical pregnancy rates following in vitro fertilization. CMAJ Open. 2013 Jun 28;1(2):E77-82. doi: 10.9778/cmajo.20120032. eCollection 2013 May.

  PMID: 25077107 DERIVED

Study Officials

• Kimberly Liu, MD FRCSC

  Mount Sinai Hospital, University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reproductive Endocrinology and Infertility Specialist

Study Record Dates

• First Submitted: May 4, 2011
• First Posted: May 5, 2011
• Study Start: April 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: June 1, 2012
• Last Updated: June 19, 2012

Record last verified: 2012-06

Locations

CA (1)