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Observational Study on GnRHa for Ovarian Preservation in SLE

This study is looking at how well a drug called Gonadotropin-releasing Hormone Agonist (GnRHa) might protect the ovaries of women with Systemic Lupus Erythematosus (SLE) who are being treated with cyclophosphamide (CYC). CYC is a strong medication for SLE, but it can sometimes harm the ovaries and lead to infertility. Researchers want to compare women who received GnRHa along with CYC to those who received CYC alone, to see if GnRHa helps prevent Primary Ovarian Insufficiency (POI), which is when ovaries stop working normally. The study will gather information from patient surveys and medical records. You could be eligible if you are a woman with SLE, under 40 years old, and are starting CYC treatment with or without GnRHa. The goal is to understand if GnRHa can help protect your ovarian health.

Study design
This is an observational study that will gather information from 100 women. It will involve reviewing medical records and conducting patient surveys.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, Primary Ovarian Insufficiency (POI), will be measured at the end of the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05567198

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

Recruiting
Not specifiedAges 18+Observational
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
~100 participants
Updated 2026-08-04 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
POI
Measured over End of study

Conditions

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

Explore related trials

Systemic Lupus Erythematosus

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

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

Who to contact

Sarfaraz A Hasni, M.D.
[email protected]
(301) 451-1599
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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

Group: Control subjects.

What this trial measures

  • POIEnd of study

    The primary outcome variable is POI, and we want to determine whether GnRH-a coadministration with CYC protects against POI incidence in pre-menopausal SLE females. The age of menopause onset will be collected from previous medical records or survey responses and compared across all three groups. Onset of menopause prior to the age of 40 will be considered POI, whereas menopause onset beyond the age of 40 will be considered natural menopause.