Reproductive Health in Men and Women With Vasculitis

Sponsor

University of South Florida (Other)

Overall Status

Completed

CT.gov ID

NCT02176070

Collaborator

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

467

Enrollment

Location

12.9

Duration (Months)

36.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Giant Cell Arteritis Takayasu's Arteritis Polyarteritis Nodosa Wegener's Granulomatosis Microscopic Polyangiitis Churg-Strauss Syndrome Behcet's Disease Kawasaki Disease Henoch-schoenlein Purpura Vasculitis, Central Nervous System Drug-induced Necrotizing 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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

467 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Reproductive Health in Men and Women With Vasculitis

Study Start Date :

Feb 1, 2011

Actual Primary Completion Date :

Mar 1, 2012

Actual Study Completion Date :

Mar 1, 2012

Outcome Measures

Primary Outcome Measures

The rate of infertility with and without prior cyc. [1 year after the study is closed to enrollment]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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