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OpenTrials
Completed

NCT Number: NCT01348594

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

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.

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Centre for Fertility and Reproductive Health, Mount Sinai Hospital

Toronto, Ontario, m5t2z5, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. implantation rates following IVF

    Time frame: 3 weeks

Secondary outcomes

  1. clinical pregnancy rates following IVF

    Time frame: 3 weeks

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
May 5, 2011
Registry last updated
Jun 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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