Infertility, FemaleNCT05848349
Vitamin D Status Among Infertile Women in Sweden
An observational study of Infertility, Female and Vitamin D Deficiency, run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
The goal of this prospective cohort study is to learn about the overall and seasonal prevalence of vitamin D insufficiency and its determinants in a population of women with infertility who will go through in vitro fertilization in Sweden. 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
- Infertility, Female, Vitamin D Deficiency
- How many people
- 265 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2020to 30 Aug 2021
- 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: Women aged 18-38 who will go through in vitro fertilization during 2020-2021 (one year) for infertility at the Department of Obstetrics and Gynecology, Sahlgrenska University Hospital in Gothenburg, Sweden.
Who may be able to join
- women aged 18-38 years, who will go through in vitro fertilization for infertility.
Who cannot join
- women who will go through pre-implantation genetic testing
- women who will go through sperm- or oocyte donation treatment
- Fertility preservation cycles
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Obstetrics and Gynecology, Sahlgrenska University Hospital
Gothenburg, 24
About this study
Official title: Vitamin D Status, Its Determinants and IVF Outcomes Among Infertile Women in South-Western Sweden.
The goal of this prospective cohort study is to learn about the overall and seasonal prevalence of vitamin D insufficiency and its determinants in a population of women with infertility who will go through in vitro fertilization in Sweden. The main questions it aims to answer are:
- What is the prevalence of vitamin D insufficiency?
- What are the determinants of this insufficiency? Participants will be asked to complete a questionnaire validated for dietary assessment of vitamin D intake and sun exposure habits and they will leave a blood sample for measurement of 25(OH)D concentration.
Researchers will compare the in vitro fertilization outcomes between women with vitamin D insufficiency and sufficiency to see if there is any difference.
- Conditions
- Infertility, Female, Vitamin D Deficiency
- Medical subject headings
- Infertility, Female, Vitamin D Deficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of vitamin D insufficiency
Overall and seasonal prevalence of vitamin D insufficiency
Measured: September 2020 - August 2021
Determinants of vitamin D insufficiency
Determinants (dietary, sun exposure habits) of vitamin D insufficiency
Measured: September 2020 - August 2021
Secondary outcomes (1)
In vitro fertilization outcomes
Pregnancy outcomes (biochemical pregnancy, clinical pregnancy, miscarriage, live birth) after in vitro fertilization between women with and without vitamin D insufficiency.
Measured: September 2020 - August 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start1 Sep 2020
- Primary completion30 Aug 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe 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
- 265 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Panagiotis Tsiartas, MD, PhD, Vastra Gotaland Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05848349
- Sponsor's protocol ID
- VitDIVF
- Status last verified
- Apr 2023
- First submitted
- 27 Apr 2023
- Last updated
- 8 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication will be made available on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Status, Its Determinants and IVF Outcomes Among Infertile Women in South-Western Sweden.
- ClinicalTrials.gov ID
- NCT05848349
- Acronym / sponsor ID
- VitDIVF
- Conditions
- Infertility, Female, Vitamin D Deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 265 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 8 May 2023 (actual)
- 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 goal of this prospective cohort study is to learn about the overall and seasonal prevalence of vitamin D insufficiency and its determinants in a population of women with infertility who will go through in vitro fertilization in Sweden. The main questions it aims to answer are:
- What is the prevalence of vitamin D insufficiency?
- What are the determinants of this insufficiency? Participants will be asked to complete a questionnaire validated for dietary assessment of vitamin D intake and sun exposure habits and they will leave a blood sample for measurement of 25(OH)D concentration.
Researchers will compare the in vitro fertilization outcomes between women with vitamin D insufficiency and sufficiency to see if there is any difference.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women aged 18-38 who will go through in vitro fertilization during 2020-2021 (one year) for infertility at the Department of Obstetrics and Gynecology, Sahlgrenska University Hospital in Gothenburg, Sweden.
Key inclusion criteria (1 listed)
- women aged 18-38 years, who will go through in vitro fertilization for infertility.
Key exclusion criteria (3 listed)
- women who will go through pre-implantation genetic testing
- women who will go through sperm- or oocyte donation treatment
- Fertility preservation cycles
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
Prevalence of vitamin D insufficiency
Time frame: September 2020 - August 2021
Overall and seasonal prevalence of vitamin D insufficiency
Determinants of vitamin D insufficiency
Time frame: September 2020 - August 2021
Determinants (dietary, sun exposure habits) of vitamin D insufficiency
1 secondary outcome
In vitro fertilization outcomes
Time frame: September 2020 - August 2021
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 8 May 2023.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication will be made available on reasonable request.
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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.
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 Infertility, Female and Vitamin D Deficiency, run by Vastra Gotaland Region at 1 site in Sweden.
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 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 8 May 2023. 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 Sweden. 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?
Prevalence of vitamin D insufficiency (time frame: September 2020 - August 2021). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2023.