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

Recruitingn/aAges 18 Years - 120 YearsFemaleNational Institute of Arthritis and Musculoskelet…
NCT05567198 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Background: Systemic lupus erythematosus (SLE) is a disease that affects females nine times more often than males. People with SLE are often treated with cyclophosphamide (CYC). But CYC can damage a woman s ovaries; it may cause infertility. A drug called GnRHa is sometimes given to protect the ovaries during CYC therapy. But no one really knows how effective GnRHa treatment is. This natural history survey will compare women who received GnRHa during CYC therapy with those who did not. Objective: To find out whether GnRHa can help protect women s ovaries during CYC. Eligibility: Women under age 40 years starting CYC treatment with or without GnRHa. Design: This study will do 2 things: It will conduct patient surveys. It will collect data from medical records. Participants will complete a one-time survey. They will answer questions about their menstrual cycle. They will be asked a

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📋 Eligibility rules (as published)
* 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.
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What it tests

  • Not listed
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Where

1 site
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Bethesda, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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