Gonadotropin-releasing Hormone Agonist (GnRHa) in Ovarian Preservation in SLE Subjects Receiving Cyclophosphamide as Determined by Questionnaires
Recruiting · NCT05567198 · Observational (researchers observe without assigning treatment) · Lead sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
View the official record on ClinicalTrials.gov →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.
Who can take part
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.
Where it is running
1 location listed across 1 US state.
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) - Bethesda, Maryland, United States