Vitamin D StatusNCT01348594
The Impact of Vitamin D Status on in Vitro Fertilization (IVF) Outcomes
An observational study of Vitamin D Status, run by University of Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Status
- How many people
- 182 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2011to Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Patients undergoing IVF at Mount Sinai Hospital
Who may be able to join
- Age > 18, < 40
- Day 3 FSH < 10
- Capable of providing informed consent
Who cannot join
- BMI > 35
- Untreated uterine pathology ie. fibroids, septum, polyps
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre for Fertility and Reproductive Health, Mount Sinai Hospital
Toronto, Ontario, m5t2z5
About this study
Official title: 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.
- Conditions
- Vitamin D Status
- Keywords
- Vitamin D, In vitro Fertilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D deficient | Not described | |
| Vitamin D sufficient | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
implantation rates following IVF
Measured: 3 weeks
Secondary outcomes (1)
clinical pregnancy rates following IVF
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2011 (estimated)
- Study startApr 2011
- Primary completionDec 2011
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitamin D StatusStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kimberly Liu, University of Toronto
- Investigators
- Kimberly Liu, MD FRCSC, Principal investigator, Mount Sinai Hospital, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01348594
- Sponsor's protocol ID
- 10-0288-E
- Status last verified
- Jun 2012
- First submitted
- 4 May 2011
- Last updated
- 19 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25077107
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Vitamin D on Implantation and Clinical Pregnancy Rates Following in Vitro Fertilization
- ClinicalTrials.gov ID
- NCT01348594
- Acronym / sponsor ID
- 10-0288-E
- Conditions
- Vitamin D Status
- Keywords
- Vitamin D, In vitro Fertilization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 5 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D deficient | – | – |
| Vitamin D sufficient | – | – |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients undergoing IVF at Mount Sinai Hospital
Key inclusion criteria (3 listed)
- Age > 18, < 40
- Day 3 FSH < 10
- Capable of providing informed consent
Key exclusion criteria (3 listed)
- BMI > 35
- Untreated uterine pathology ie. fibroids, septum, polyps
- Unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
implantation rates following IVF
Time frame: 3 weeks
1 secondary outcome
clinical pregnancy rates following IVF
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2012.
- Derived from this study: PubMed 25077107Garbedian 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimberly Liu, MD FRCSC principal investigator
Mount Sinai Hospital, University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin D Status, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
implantation rates following IVF (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01348594, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2012.