Reproductive Health in Men and Women With Vasculitis

Completed

• Conditions: Giant Cell Arteritis; Takayasu's Arteritis; Polyarteritis Nodosa; Wegener's Granulomatosis; Microscopic Polyangiitis; Churg-Strauss Syndrome; Behcet's Disease; Henoch-schoenlein Purpura; Vasculitis, Central Nervous System; Drug-induced Necrotizing Vasculitis

• Registration Number: NCT02176070
• Lead Sponsor: University of South Florida

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 Timeline

• Study Start: 2011-02
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Study First Submitted: 2014-05-30
• Status Verified: 2014-06
• Study First Submitted QC: 2014-06-25
• Last Update Submitted: 2014-06-25
• Study First Posted: 2014-06-26
• Last Update Posted: 2014-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 467

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The rate of infertility with and without prior cyc.	1 year after the study is closed to enrollment

Secondary Outcome Measures

Name	Time	Method
The rate of pregnancy complications in pregnancies delivered before and after vasculitis diagnosis.	1 year after the study is closed to enrollment

Trial Locations

Locations (1)

University of South Florida Data Management Coordinating Center; 🇺🇸 Tampa, Florida, United States