NCT03173235

Brief Summary

1,25-dihydroxy-vitamin D3 (1,25 (OH) 2D3) or calcitriol regulates plasma calcium and phosphate concentrations in the blood by stimulating intestinal absorption and renal reabsorption of calcium and phosphate. 1.25 (OH) 2D3 is formed by the renal 1α25OH vitamin D-hydroxylase (Cyp27b1) and inactivated by the renal 25-hydroxy vitamin D-24-hydroxylase (Cyp24). Unpublished studies in mice revealed an inhibitory effect of 1.25 (OH) 2D3 on embryo implanation. An excess of 1.25 (OH) 2D3 could therefore lead to female infertility. The excess of 1.25 (OH) 2D3 could result from uncritical vitamin D intake with insufficient negative feedback by FGF23 / Klotho. The aim of the study is to identify patients with an excess of 1.25 (OH) 2D3.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2015

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 1, 2017

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

January 22, 2025

Status Verified

January 1, 2025

Enrollment Period

6.3 years

First QC Date

May 30, 2017

Last Update Submit

January 17, 2025

Conditions

Infertility, Female

Outcome Measures

Primary Outcomes (1)

  • Plasma level of 25(OH)D3 and 1,25(OH)2D3

    1 day

Study Arms (2)

Infertile women

Women which desire to have children but are probable infertile between 18 and 45 year old

Diagnostic Test: Plasma level of vitamin D

healthy women

Healthy women without systemic diseases in the age of 18 to 45 years

Diagnostic Test: Plasma level of vitamin D

Interventions

Plasma level of vitamin DDIAGNOSTIC_TEST

messurement of plasma level of vitamin D

Infertile womenhealthy women

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women in the age of 18 to 45 years

You may not qualify if:

  • Known systemic diseases, e.g. Autoimmune disease, scleroderma, malignant disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Women's Hospital

Tübingen, 72076, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood plasma

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2017

First Posted

June 1, 2017

Study Start

August 1, 2015

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

January 22, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)