Actively Recruiting

Age: 18Years - 120Years
FEMALE
ID05567198

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

Led by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · Updated on 2026-06-03

100

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Systemic lupus erythematosus (SLE) is a condition that affects females much more often than males. This research aims to find out if a drug called Gonadotropin-releasing hormone agonist (GnRHa) can protect women's ovaries during treatment with cyclophosphamide (CYC), which is commonly used for severe SLE but may cause infertility by damaging ovaries. The study compares women receiving CYC with GnRHa to those receiving CYC alone and also includes a control group of women with SLE who have not received CYC. Participants fall into three groups: women receiving CYC alone, women receiving both CYC and GnRHa (leuprolide acetate injected monthly or every three months), and age-matched female SLE patients without reproductive disorders who have not received CYC. The study collects data through patient surveys and medical record reviews. The survey asks about menstrual cycles, pregnancy history, and infertility, and can be completed on paper, online, by phone, or in person. During the study, researchers review medical records for SLE disease activity, blood test results, prior treatments, and reproductive health history including fertility treatments and sexually transmitted infections. The main outcome measured is primary ovarian insufficiency (POI) at the end of the study. Secondary measures include the effects of treatment on menstrual cycles and disease activity scores. Participation involves a one-time 30-minute survey and medical records review, with data collected securely to assess ovarian function and the impact of GnRHa co-treatment during CYC therapy.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 120Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female with systemic lupus erythematosus (SLE) under 40 years old at the start of cyclophosphamide (CYC) treatment
  • Receiving CYC alone or CYC with GnRH agonist (leuprolide acetate) treatment
  • Age-matched female SLE patients without reproductive disorders who have not received CYC
  • Able to complete a one-time survey about menstrual and reproductive history
Not Eligible

You will not qualify if you...

  • Female over 40 years old at the start of cyclophosphamide treatment
  • History of reproductive disorders or infertility
  • Untreated sexually transmitted infections
  • Not receiving cyclophosphamide treatment for SLE

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or remote) to confirm eligibility and collect baseline information

Monitoring

Duration - Single timepoint during the study period

Participants who have received cyclophosphamide with or without GnRH agonist, or age-matched SLE patients without reproductive disorders, complete a one-time survey about menstrual and reproductive history and have retrospective data collected to assess ovarian function.

1 visit (in-person or remote) for survey completion and data collection

Trial Site Locations

Total: 1 location

1

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

Bethesda, Maryland, United States, 20892

Actively Recruiting

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Research Team

S

Sarfaraz A Hasni, M.D.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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Published Research Related To This Trial

[Effect of increased chloride on the spontaneous release of acetylcholine in the neuromuscular synapses of amphibia poisoned with Clostridium toxin Type A].

B Stamenović

https://pubmed.ncbi.nlm.nih.gov/4555317