Actively Recruiting
Gonadotropin-releasing Hormone Agonist (GnRHa) in Ovarian Preservation in SLE Subjects Receiving Cyclophosphamide as Determined by Questionnaires
Led by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · Updated on 2026-04-28
100
Participants Needed
1
Research Sites
221 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 about their history of pregnancy or infertility. Participants can take the survey in 4 ways: On paper, sent through the mail. Online, in a secure web page managed by the NIH. By phone. In person, during a routine visit to the NIH clinic. The survey will take about 30 minutes. Participants medical records will be reviewed. Researchers will look for data about the participants SLE disease. This may include their symptoms and the results of their blood tests. It may also include the details of prior treatments. Researchers will also collect data about participants reproductive history. This may include their personal or family history of infertility. It may include any fertility treatments and any sexually transmitted infections.
CONDITIONS
Official Title
Gonadotropin-releasing Hormone Agonist (GnRHa) in Ovarian Preservation in SLE Subjects Receiving Cyclophosphamide as Determined by Questionnaires
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female with systemic lupus erythematosus (SLE) under 40 years old at the start of cyclophosphamide (CYC) treatment without GnRHa cotreatment
- Female with SLE under 40 years old at the start of CYC treatment with GnRHa cotreatment (leuprolide acetate 3.75 mg/month or 11.25 mg every 3 months)
- Age-matched female SLE patients without history of reproductive disorders, infertility, or untreated sexually transmitted infections (STIs) who have not received CYC with or without GnRHa
You will not qualify if you...
- Female older than 40 years at the start of CYC treatment
- Any female with prior history of reproductive disorders or infertility
- Any female with untreated sexually transmitted infections (STIs)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
S
Sarfaraz A Hasni, M.D.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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