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