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

    • Ontario
      • Toronto, Ontario, Canada, m5t2z5
        • Centre for Fertility and Reproductive Health, Mount Sinai Hospital

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
Vitamin D deficient
Vitamin D sufficient

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
implantation rates following IVF
Time Frame: 3 weeks
3 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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.

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

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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