Vitamin D DeficiencyVIDIONCT02187146
The Effects of Serum Vitamin D and IVF Outcome
An observational study of Vitamin D Deficiency and Vitamin D Insufficiency, run by University of Birmingham at 1 site in United Kingdom.
Trial summary
The purpose of this study is to investigate whether an association exists between serum vitamin D levels and IVF treatment outcome Read more about this study
- Who is it for?
- Ages 23 to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency, Vitamin D Insufficiency, Infertility
- How many people
- 504 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2013to Dec 2015
- 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 23 to 43 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: All patients undergoing IVF, ICSI and FET treatment cycles at the Birmingham Womens Fertility Centre
Who may be able to join
- All patients undergoing IVF, ICSI or FET treatment at Birmingham Womens Fertility Centre
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Birmingham Womens NHS Foundation Trust
Birmingham, West Midlands, B15 2TG
About this study
Official title: The Effects of Serum Vitamin D and IVF Outcome: a Prospective Cohort Study
The purpose of this study is to investigate whether an association exists between serum vitamin D levels and IVF treatment outcome
- Conditions
- Vitamin D Deficiency, Vitamin D Insufficiency, Infertility
- Keywords
- Vitamin D, Infertility, IVF, ART
- Medical subject headings
- Vitamin D Deficiency, Infertility
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 |
|---|---|---|
| ART population | Patients undergoing IVF/ICSI/FET treatment at the Birmingham Womens Fertility Centre 2013-2014 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Pregnancy Rate
USS appearances of intrauterine pregnancy
Measured: 7 weeks after embryo transfer
Secondary outcomes (3)
Biochemical pregnancy rate
Urinary pregnancy test result 2 weeks after embryo transfer
Measured: 2 weeks after embryo transfer
Miscarriage rate
Pregnancy outcome of miscarriage
Measured: 20 weeks after embryo transfer
Live birth rate
Live birth outcome
Measured: 42 weeks after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study startSep 2013
- Primary completionDec 2014
- Study completionDec 2015
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 DeficiencyStudies of the same condition, open and under way.
- 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
- 504 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Justin Chu, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02187146
- Sponsor's protocol ID
- RG_13-100
- Acronym
- VIDIO
- Status last verified
- Oct 2016
- First submitted
- 8 Jul 2014
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chu J, Gallos I, Tobias A, Robinson L, Kirkman-Brown J, Dhillon-Smith R, Harb H, Eapen A, Rajkhowa M, Coomarasamy A. Vitamin D and assisted reproductive treatment outcome: a prospective cohort study. Reprod Health. 2019 Jul 15;16(1):106. doi: 10.1186/s12978-019-0769-7.
PubMed 31307482
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Serum Vitamin D and IVF Outcome: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT02187146
- Acronym / sponsor ID
- VIDIO / RG_13-100
- Conditions
- Vitamin D Deficiency, Vitamin D Insufficiency, Infertility
- Keywords
- Vitamin D, Infertility, IVF, ART
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 504 participants (actual)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 10 Jul 2014 (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.
The purpose of this study is to investigate whether an association exists between serum vitamin D levels and IVF treatment outcome
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ART population | – | –Patients undergoing IVF/ICSI/FET treatment at the Birmingham Womens Fertility Centre 2013-2014 |
Who may qualify
- Ages
- 23 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All patients undergoing IVF, ICSI and FET treatment cycles at the Birmingham Womens Fertility Centre
Key inclusion criteria (1 listed)
- All patients undergoing IVF, ICSI or FET treatment at Birmingham Womens Fertility Centre
Key exclusion criteria (1 listed)
- None
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
Clinical Pregnancy Rate
Time frame: 7 weeks after embryo transfer
USS appearances of intrauterine pregnancy
3 secondary outcomes
Biochemical pregnancy rate
Time frame: 2 weeks after embryo transfer
Miscarriage rate
Time frame: 20 weeks after embryo transfer
Live birth rate
Time frame: 42 weeks after embryo transfer
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 25 Oct 2016.
- Derived from this study: PubMed 31307482Chu J, Gallos I, Tobias A, Robinson L, Kirkman-Brown J, Dhillon-Smith R, Harb H, Eapen A, Rajkhowa M, Coomarasamy A. Vitamin D and assisted reproductive treatment outcome: a prospective cohort study. Reprod Health. 2019 Jul 15;16(1):106. doi: 10.1186/s12978-019-0769-7.
Related trials for Vitamin D Deficiency
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Not yet recruitingPhase 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
Recruiting
Role of Vitamin D Supplementation in Children With Irritable Bowel Syndrome
Irritable Bowel Syndrome (IBS), Vitamin D Deficiency
RecruitingObservational study
Post Marketing Surveillance Study to Observe Safety and Effectiveness of CRYSVITA® in S. Korean Patients
FGF23-related Hypophosphataemic Rickets and Osteomalacia
Not yet recruiting
Effect of Vitamin D Supplementation Added to Iron Therapy in Children With Iron Deficiency Anemia
Iron Deficiency Anemia
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Deficiency and Vitamin D Insufficiency, run by University of Birmingham at 1 site in United Kingdom.
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 1 inclusion and 1 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 25 Oct 2016. 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 United Kingdom. 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?
Clinical Pregnancy Rate (time frame: 7 weeks after embryo transfer). 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 NCT02187146, 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 25 Oct 2016.