Gonadotropin-releasing Hormone Agonist (GnRHa) in Ovarian Preservation in SLE Subjects Receiving Cyclophosphamide as Determined by Questionnaires
NCT ID: NCT05567198
Last Updated: 2025-06-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2023-03-03
2026-05-31
Brief Summary
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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.
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Detailed Description
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Objectives:
Primary Objective: Determine the effectiveness of GnRH-a in preventing primary ovarian insufficiency (POI) in female SLE patients getting cyclophosphamide treatment.
Secondary Objectives: Determine the effects of SLE disease activity, damage accrual, cumulative dose of cyclophosphamide and other demographic and clinical variables in preventing primary ovarian insufficiency.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Group 1
SLE patients receiving CYC alone
No interventions assigned to this group
Group 2
SLE patients receiving both CYC and leuprolide acetate (GnRH-a)
No interventions assigned to this group
Group 3
Control subjects, Age-matched female SLE patients without a history of reproductive disorders
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
SLE females \<40 years at the beginning of CYC treatment with GnRH-a cotreatment.
Exclusion Criteria
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.
18 Years
120 Years
FEMALE
No
Sponsors
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National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
NIH
Responsible Party
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Principal Investigators
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Sarfaraz A Hasni, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Locations
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National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Bethesda, Maryland, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Friedman RC, Clarkin JF, Corn R, Aronoff MS, Hurt SW, Murphy MC. DSM-III and affective pathology in hospitalized adolescents. J Nerv Ment Dis. 1982 Sep;170(9):511-21. doi: 10.1097/00005053-198209000-00001. No abstract available.
Kiriakidou M, Cotton D, Taichman D, Williams S. Systemic lupus erythematosus. Ann Intern Med. 2013 Oct 1;159(7):ITC4-1. doi: 10.7326/0003-4819-159-7-201310010-01004. No abstract available.
Stamenovic B. [Effect of increased chloride on the spontaneous release of acetylcholine in the neuromuscular synapses of amphibia poisoned with Clostridium toxin Type A]. Vojnosanit Pregl. 1972 Mar;29(3):139-44. No abstract available. Serbian.
Other Identifiers
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001011-AR
Identifier Type: -
Identifier Source: secondary_id
10001011
Identifier Type: -
Identifier Source: org_study_id
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