Vitamin D Status Among Infertile Women in Sweden

Completed

• Conditions: Infertility, Female; Vitamin D Deficiency

• Registration Number: NCT05848349
• Lead Sponsor: Vastra Gotaland Region

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-01
• Primary Completion: 2021-08-30
• Study Completion: 2021-08-30
• Status Verified: 2023-04
• Study First Submitted: 2023-04-27
• Study First Submitted QC: 2023-04-27
• Last Update Submitted: 2023-04-27
• Study First Posted: 2023-05-08
• Last Update Posted: 2023-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 265

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of vitamin D insufficiency	September 2020 - August 2021	Overall and seasonal prevalence of vitamin D insufficiency
Determinants of vitamin D insufficiency	September 2020 - August 2021	Determinants (dietary, sun exposure habits) of vitamin D insufficiency

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden