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

NCT ID: NCT01348594

Last Updated: 2012-06-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 182 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2012-06-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Vitamin D deficient

No interventions assigned to this group

Vitamin D sufficient

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Toronto

OTHER

Sponsor Role: lead

Responsible Party

Kimberly Liu

Reproductive Endocrinology and Infertility Specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kimberly Liu, MD FRCSC

Role: PRINCIPAL_INVESTIGATOR

Mount Sinai Hospital, University of Toronto

Locations

Centre for Fertility and Reproductive Health, Mount Sinai Hospital

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 25077107 (View on PubMed)

Other Identifiers

10-0288-E

Identifier Type: -

Identifier Source: org_study_id