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

Launched by NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES (NIAMS) · Oct 4, 2022

Keywords

ClinConnect Summary

This clinical trial is studying whether a medication called GnRHa can help protect the ovaries of young women with systemic lupus erythematosus (SLE) who are being treated with cyclophosphamide (CYC). CYC is often used for SLE, but it can harm the ovaries and lead to infertility. The trial will compare women who receive CYC alone to those who receive CYC along with GnRHa. The goal is to find out if GnRHa is effective in preserving ovarian function during CYC treatment.

To participate, women under 40 years old who are starting CYC treatment can join the study. Participants will complete a one-time survey that takes about 30 minutes, which can be done in several ways: on paper, online, by phone, or in person at the NIH clinic. The survey will ask about their menstrual cycles, pregnancy history, and any fertility issues. Additionally, researchers will review medical records to gather more information about the participants' SLE and reproductive health. This study is currently recruiting participants, and it aims to help improve care for women facing fertility risks due to SLE treatments.

Gender

FEMALE

Eligibility criteria

• * ELIGIBILITY CRITERIA:
• • INCLUSION CRITERIA: Group 1: SLE patients receiving CYC alone
• • SLE females \<40 years at the beginning of CYC treatment without GnRH-a cotreatment.
• • -EXCLUSION CRITERIA: Group 1: SLE patients receiving CYC alone
• • Females \>40 years at the beginning of CYC treatment; any females with a prior history of reproductive disorders, infertility, or untreated sexually transmitted infections (STIs).
• • -INCLUSION CRITERIA: Group 2: SLE patients receiving both CYC and leuprolide acetate (GnRH-a). Leuprolide acetate was injected at a dose of either 3.75 mg/month or 11.25mg/every 3 months.
• • SLE females \<40 years at the beginning of CYC treatment with GnRH-a cotreatment.
• • -EXCLUSION CRITERIA: Group 2: SLE patients receiving both CYC and leuprolide acetate (GnRH-a). Leuprolide acetate was injected at a dose of either 3.75 mg/month or 11.25mg/every 3 months.
• • Females \>40 years at the beginning of CYC treatment; any females with a prior history of reproductive disorders, infertility, or untreated STIs.
• • -Group: Control subjects.
• • Age-matched female SLE patients without a history of reproductive disorders, infertility, or untreated STIs, who have not received CYC either with or without GnRH-a.