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OpenTrials
Completed

NCT Number: NCT05848349

Vitamin D Status Among Infertile Women in 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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Department of Obstetrics and Gynecology, Sahlgrenska University Hospital

Gothenburg, 24, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Prevalence of vitamin D insufficiency

    Time frame: September 2020 - August 2021

    Overall and seasonal prevalence of vitamin D insufficiency

  2. Determinants of vitamin D insufficiency

    Time frame: September 2020 - August 2021

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

Secondary outcomes

  1. In vitro fertilization outcomes

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Registry information

Official study title

Vitamin D Status, Its Determinants and IVF Outcomes Among Infertile Women in South-Western Sweden.

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 8, 2023
Registry last updated
May 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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