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

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Study ID
NCT05567198
Status
Recruiting
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Conditions

  • Primary Ovarian Insufficiency (Poi)
  • Systemic Lupus Erythematosus (Sle)

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Mar 3, 2023
Status verified
Mar 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Group 1
    SLE patients receiving CYC alone
  • Arm: Group 2
    SLE patients receiving both CYC and leuprolide acetate (GnRH-a)
  • Arm: Group 3
    Control subjects, Age-matched female SLE patients without a history of reproductive disorders

Primary Outcome Measure

POI [ Time Frame: End of study ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)BethesdaMaryland20892
Sarfaraz Hasni, M.D.
[email protected]
301-451-1599

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National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)· Bethesda, MD

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