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

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Observational

Phase

Not applicable / not listed

Age range

18 years - 120 years

Sex eligible

Female

Healthy volunteers

Not accepted

Participants

100 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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 may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

• ELIGIBILITY CRITERIA:
• 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.

Study population

This is a single-site study which will include women with SLE (diagnosed according to the revised American College of Rheumatology criteria). The participants will be stratified in 3 groups: 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. The subjects screening and retrospective data collection and will be performed by searching electronic medical records for SLE patients treated under SLE Natural History and Pathogenesis Study (Protocol # 94-AR-0066) at the NIH Clinical Center. This protocol and protocol # 94-AR-0066 are under the same PI.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not reported

Masking

Not reported

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

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

Study start

Mar 3, 2023 Actual

Primary completion

May 31, 2027 Estimated

Study completion

May 31, 2027 Estimated

First posted

Oct 5, 2022 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts