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

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 120
Healthy Volunteers: f
View:

• SLE females \<40 years at the beginning of CYC treatment without GnRH-a cotreatment.

• SLE females \<40 years at the beginning of CYC treatment with GnRH-a cotreatment.

Locations
United States
Maryland
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
RECRUITING
Bethesda
Contact Information
Primary
Sarfaraz A Hasni, M.D.
hasnisa@mail.nih.gov
(301) 451-1599
Time Frame
Start Date: 2023-03-03
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 100
Treatments
Group 1
SLE patients receiving CYC alone
Group 2
SLE patients receiving both CYC and leuprolide acetate (GnRH-a)
Group 3
Control subjects, Age-matched female SLE patients without a history of reproductive disorders
Sponsors
Leads: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

This content was sourced from clinicaltrials.gov