Study of GnRH Agonist GnRHa to Protect Ovaries in Women with Lupus Receiving Cyclophosphamide Treatment

What this Trial Is About

Systemic lupus erythematosus SLE is a condition that affects women much more often than men. Patients with severe lupus symptoms are often treated with cyclophosphamide CYC, a drug that can harm the ovaries and may cause infertility. This study is investigating whether giving a drug called gonadotropin-releasing hormone agonist GnRHa alongside CYC can protect ovarian function in women with SLE. Researchers want to understand if GnRHa helps prevent primary ovarian insufficiency in this group. The study compares three groups women with SLE receiving CYC alone, women receiving CYC plus GnRHa injections, and a control group of women with SLE who have not had CYC or GnRHa treatment and have no reproductive disorders. GnRHa is given as injections of either 3.75 mg monthly or 11.25 mg every three months during CYC therapy. Participants complete a one-time survey about their menstrual cycles, pregnancy history, and infertility, which can be done by mail, online, phone, or in person. Medical records are also reviewed to collect information about lupus symptoms, blood tests, previous treatments, reproductive history, and fertility-related factors. Participants will be surveyed once, taking about 30 minutes to complete. Researchers will analyze menstrual cycle changes, lupus disease activity scores, and ovarian function using data from medical records and questionnaires. The main focus is on whether primary ovarian insufficiency develops. The study is observational and collects information retrospectively and from patient reports. Participation involves completing the survey and allowing access to medical records. The study is expected to continue through May 2027.

Gonadotropin-releasing Hormone Agonist (GnRHa) in Ovarian Preservation in SLE Subjects Receiving Cyclophosphamide as Determined by Questionnaires