NCT02912442

Brief Summary

The present Ph.D.-study investigates the mechanisms behind the association between thyroid autoimmunity and reproductive failure.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

September 21, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 23, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

September 23, 2016

Status Verified

September 1, 2016

Enrollment Period

3 years

First QC Date

September 21, 2016

Last Update Submit

September 21, 2016

Conditions

ThyroidInfertilityAutoantibodiesAutoimmunityPregnancy Loss

Keywords

thyroidinfertilityautoimmunitypregnancy lossautoantibodies

Outcome Measures

Primary Outcomes (1)

  • Live birth

    2011-2015

Study Arms (3)

Infertile women study 1

Infertile women study 2

Repeated pregnancy loss

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women referred to the infertility clinic

You may qualify if:

  • Women followed in the Fertility Clinic

You may not qualify if:

  • Pregnancy at time of blood sampling. Immune-suppressive ⁄modulatory treatments. Women referred for oocyt donation, genetic testing, and hepatitis and HIV-positivity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Thyroid DiseasesInfertilityAutoimmune Diseases

Condition Hierarchy (Ancestors)

Endocrine System DiseasesGenital DiseasesUrogenital DiseasesImmune System Diseases

Central Study Contacts

Ulla Feldt-Rasmussen, Proff., DMSc

CONTACT

ulla.feldt-rasmussen@dadlnet.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, DMSc

Study Record Dates

First Submitted

September 21, 2016

First Posted

September 23, 2016

Study Start

December 1, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2020

Last Updated

September 23, 2016

Record last verified: 2016-09

Locations

DK(1)