Reproductive Health in Men and Women With Vasculitis

June 25, 2014 updated by: University of South Florida
The purpose of this study is to learn about reproductive health, including fertility and pregnancies, in people with vasculitis.

Study Overview

Status

Completed

Conditions

Detailed Description

All patients enrolled in the Vasculitis Clinical Research Consortium's Contact Registry were invited via email to participate in this study. The Contract Registry includes people who self-identify as having one of 6 vasculitities: Wegener's Granulomatosis, Microscopic Polyangiitis, Churg-Strauss Syndrome, Polyarteritis Nodosum, Takayasu's Arteritis, and Giant Cell Arteritis. People voluntarily enroll in this Registry with the understanding that they will receive information about clinical studies for which they might be eligible. The introductory email included basic information about the study and all of the required elements for informed consent in a brief format. By clicking the link to the reproductive health questionnaire, participants gave their consent to be included in the study.

Study Type

Observational

Enrollment (Actual)

467

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • University of South Florida Data Management Coordinating Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients with vasculitis included in the VCRC Contact Registry were invited to participate. Data was included for all patients who provided a vasculitis diagnosis, estimated date of diagnosis, confirmed that the diagnosis was made by a rheumatologist, and reported having taken at least one appropriate anti-rheumatic medication. Other participants were excluded as the likelihood that they have a true vasculitis condition is low.

Description

Inclusion Criteria:

  • Enrolled in VCRC Contact Registry
  • Patient reported diagnosis of Wegener's Granulomatosis, Microscopic Polyangiitis, Churg-Strauss Syndrome, Polyarteritis Nodosa, Takayasu's Arteritis, Giant Cell Arteritis, Behcet's Disease, Kawasaki Disease, Henoch-Schoenlein Purpura, CNS or Drug-induced Vasculitis
  • 18 years of age or older
  • English speaking

Exclusion Criteria:

  • Inability to provide informed consent and complete survey

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The rate of infertility with and without prior cyc.
Time Frame: 1 year after the study is closed to enrollment
1 year after the study is closed to enrollment

Secondary Outcome Measures

Outcome Measure
Time Frame
The rate of pregnancy complications in pregnancies delivered before and after vasculitis diagnosis.
Time Frame: 1 year after the study is closed to enrollment
1 year after the study is closed to enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of South Florida

Collaborators

Boston University
Duke University
Data Management and Coordinating Center (DMCC)

Investigators

  • Study Chair: Amanda M. Terry, MA, USF College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (ACTUAL)

March 1, 2012

Study Completion (ACTUAL)

March 1, 2012

Study Registration Dates

First Submitted

May 30, 2014

First Submitted That Met QC Criteria

June 25, 2014

First Posted (ESTIMATE)

June 26, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

June 26, 2014

Last Update Submitted That Met QC Criteria

June 25, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5531

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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