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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01348594
First Posted: May 5, 2011
Last Update Posted: June 19, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kimberly Liu, University of Toronto
  Purpose
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.

Condition
Vitamin D Status

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Impact of Vitamin D on Implantation and Clinical Pregnancy Rates Following in Vitro Fertilization

Resource links provided by NLM:


Further study details as provided by Kimberly Liu, University of Toronto:

Primary Outcome Measures:
  • implantation rates following IVF [ Time Frame: 3 weeks ]

Secondary Outcome Measures:
  • clinical pregnancy rates following IVF [ Time Frame: 3 weeks ]

Enrollment: 182
Study Start Date: April 2011
Study Completion Date: June 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Vitamin D deficient
Vitamin D sufficient

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing IVF at Mount Sinai Hospital
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01348594


Locations
Canada, Ontario
Centre for Fertility and Reproductive Health, Mount Sinai Hospital
Toronto, Ontario, Canada, m5t2z5
Sponsors and Collaborators
University of Toronto
Investigators
Principal Investigator: Kimberly Liu, MD FRCSC Mount Sinai Hospital, University of Toronto
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kimberly Liu, Reproductive Endocrinology and Infertility Specialist, University of Toronto
ClinicalTrials.gov Identifier: NCT01348594     History of Changes
Other Study ID Numbers: 10-0288-E
First Submitted: May 4, 2011
First Posted: May 5, 2011
Last Update Posted: June 19, 2012
Last Verified: June 2012

Keywords provided by Kimberly Liu, University of Toronto:
Vitamin D
In vitro Fertilization

Additional relevant MeSH terms:
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents