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

NCT05567198 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2026-04-28

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

    lead NIH

Principal Investigators

  • Sarfaraz A Hasni, M.D. · National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-03
Primary Completion
2027-05-31
Completion
2027-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05567198 on ClinicalTrials.gov