5531: Reproductive Health in Men and Women with Vasculitis

Status: Closed to Accrual

Summary

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

For Diseases

Wegener’s Granulomatosis, Microscopic Polyangiitis, Churg-Strauss Syndrome, Polyarteritis Nodosa, Takayasu’s Arteritis, Giant Cell (Temporal) Arteritis, Behcet’s Disease, Kawasaki Disease, Henoch-Schoenlein Purpura, CNS Vasculitis, Drug-induced Vasculitis

Background

The reproductive health of men and women with vasculitis has not been previously studied. We do not know if there is a higher than expected rate of infertility, early menopause, or pregnancy complications. Many patients with vasculitis are treated with cyclophosphamide (CYC), an alkylating agent that causes infertility in 30-50% of treated patients. The rate of infertility, however, has not been measured in this cohort of patients. We recently evaluated a cohort of young women with Wegener’s Granulomatosus (WG) for ovarian reserve, measured by the anti-mullerian hormone (AMH). We found that the women with WG without CYC therapy maintained normal ovarian reserve, however women treated with CYC suffered a dramatic decline. This study was a post-hoc analysis of a completed trial, so follow-up data on fertility and menopause was not available to provide a clear clinical picture of the ovarian dysfunction suffered by these women. This will be the largest study of fertility in men and women with vasculitis to date. It will provide important information that will guide clinical therapy in young patients with vasculitis.

Fertility preservation methods are available for men and women prior to therapy with CYC. For men, sperm cryopreservation is an established and reliable method. For women, there are several options, though none as simple and dependable as for men. Ovarian, embryo, and oocyte cryopreservation are options. Co-therapy with a GnRH-agonist, such as leuprolide, may cause the ovary to ‘hibernate’ during chemotherapy, thus preserving more of the ovarian follicles and future fertility. In a meta-analysis published earlier this year, we found that GnRH-agonist co-therapy increased the chances for ovarian function, measured by continued menses and low FSH, by 68%. Whether this option preserves fertility is less well documented, though in the meta-analysis we found that co-therapy increased the chances of pregnancy. In this study, we will learn the rate of fertility preservation method utilization in the general population of vasculitis patients, as well as an estimate of the success rate of these methods.

Pregnancies are rare in women with vasculitis and all available data comes from case reports and small case series. We expect to identify the largest number of vasculitis pregnancies and to be able to identify unique pregnancy risks in this population. We will look for congenital anomalies in the offspring of men with vasculitis and will be able to compare these rates in men with and without prior CYC therapy. In addition, we will learn the pregnancy and vasculitis complications for women who become pregnant following a diagnosis of vasculitis.

This study is important because it will provide new, needed, clinical information and guidance to physicians and patients with vasculitis. We hope that it will raise awareness for fertility preservation methods. In addition, the pregnancy data that we will find will provide needed insight into these rare events. We are also planning a prospective pregnancy registry for patients with vasculitis and the information gleamed from this study will assist in the design, implementation, and funding of that project.

About this Study

All patients enrolled in the Vasculitis Clinical Research Consortium’s Contact Registry will be invited via email to participate in this study. The Contract Registry includes people who self-identify as having one of 11 vasculities: 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. 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 will include basic information about the study and all of the required elements for informed consent in a brief format. Once participants agree to participate in the study, then they will be directed to the online questionnaire.

When completing the questionnaire, the patients will be asked a series of questions. The follow-up questions will depend on initial answers. Men and women will see different questions, when applicable. The questionnaire content is included as an appendix. The online questionnaire version will be thoroughly tested for usability.

It is expected that most participants will require 20-30 minutes to complete the questionnaire, mostly dependent on the number of pregnancies and offspring.

The survey data will be stored by the Rare Diseases Clinical Research Network Data Management and Coordinating Center (DMCC) at the University of South Florida. The data will be de-identified. Names or other personal health information will not be collected.

Target Enrollment:

To be eligible to participate, you must:

  1. Be enrolled in the VCRC Contact Registry
  2. Be a patient with a 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
  3. Be 18 years of age or older
  4. Be English speaking

You are not eligible to participate if:

  • You are unable to provide informed consent and complete the survey
 

If you have any questions about this study, please contact rdnwebmaster@epi.usf.edu