NCT05848349

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
265

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

April 27, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 8, 2023

Completed
Last Updated

May 8, 2023

Status Verified

April 1, 2023

Enrollment Period

12 months

First QC Date

April 27, 2023

Last Update Submit

April 27, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Prevalence of vitamin D insufficiency

    Overall and seasonal prevalence of vitamin D insufficiency

    September 2020 - August 2021

  • Determinants of vitamin D insufficiency

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

    September 2020 - August 2021

Secondary Outcomes (1)

  • In vitro fertilization outcomes

    September 2020 - August 2021

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • women aged 18-38 years, who will go through in vitro fertilization for infertility.

You may not qualify if:

  • women who will go through pre-implantation genetic testing
  • women who will go through sperm- or oocyte donation treatment
  • Fertility preservation cycles

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology, Sahlgrenska University Hospital

Gothenburg, 24, Sweden

Location

MeSH Terms

Conditions

Infertility, FemaleVitamin D Deficiency

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertilityAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Consultant, M.D., Ph.D.

Study Record Dates

First Submitted

April 27, 2023

First Posted

May 8, 2023

Study Start

September 1, 2020

Primary Completion

August 30, 2021

Study Completion

August 30, 2021

Last Updated

May 8, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will share

All IPD that underlie results in a publication will be made available on reasonable request.

Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations