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Vitamin D Status Among Infertile Women in Sweden

Sponsor
Vastra Gotaland Region (Other)
Overall Status
Completed
CT.gov ID
NCT05848349
Collaborator
(none)
265
Enrollment
1
Location
11.9
Actual Duration (Months)
22.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    265 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Vitamin D Status, Its Determinants and IVF Outcomes Among Infertile Women in South-Western Sweden.
    Actual Study Start Date :
    Sep 1, 2020
    Actual Primary Completion Date :
    Aug 30, 2021
    Actual Study Completion Date :
    Aug 30, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Prevalence of vitamin D insufficiency [September 2020 - August 2021]

      Overall and seasonal prevalence of vitamin D insufficiency

    2. Determinants of vitamin D insufficiency [September 2020 - August 2021]

      Determinants (dietary, sun exposure habits) of vitamin D insufficiency

    Secondary Outcome Measures

    1. In vitro fertilization outcomes [September 2020 - August 2021]

      Pregnancy outcomes (biochemical pregnancy, clinical pregnancy, miscarriage, live birth) after in vitro fertilization between women with and without vitamin D insufficiency.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • women aged 18-38 years, who will go through in vitro fertilization for infertility.
    Exclusion Criteria:

    • women who will go through pre-implantation genetic testing

    • women who will go through sperm- or oocyte donation treatment

    • Fertility preservation cycles

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Obstetrics and Gynecology, Sahlgrenska University Hospital Gothenburg Sweden 24

    Sponsors and Collaborators

    • Vastra Gotaland Region

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Panagiotis Tsiartas, MD, PhD, Senior Consultant, M.D., Ph.D., Vastra Gotaland Region
    ClinicalTrials.gov Identifier:
    NCT05848349
    Other Study ID Numbers:
    • VitDIVF
    First Posted:
    May 8, 2023
    Last Update Posted:
    May 8, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Infertility
    Infertility, Female
    Vitamin D Deficiency

    Study Results

    No Results Posted as of May 8, 2023