Reproductive Health in Men and Women With Vasculitis

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Brief Title

Reproductive Health in Men and Women With Vasculitis

Official Title

Reproductive Health in Men and Women With Vasculitis

Brief Summary

      The purpose of this study is to learn about reproductive health, including fertility and
      pregnancies, in people with vasculitis.
    

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 [Patient Registry]


Primary Outcome

The rate of infertility with and without prior cyc.

Secondary Outcome

 The rate of pregnancy complications in pregnancies delivered before and after vasculitis diagnosis.

Condition

Giant Cell Arteritis



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

467

Start Date

February 2011

Completion Date

March 2012

Primary Completion Date

March 2012

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Megan Clowse, MD, MPH, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02176070

Organization ID

5531


Responsible Party

Sponsor

Study Sponsor

University of South Florida

Collaborators

 Duke University

Study Sponsor

Megan Clowse, MD, MPH, Study Chair, Duke University


Verification Date

June 2014