Evaluating the effectiveness of GnRHa for ovarian protection in women with lupus undergoing cyclophosphamide treatment

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

This study is testing whether a hormone treatment can help protect the ovaries of women under 40 with lupus who are getting chemotherapy.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years to 120 Years
• Sex: Female
• Sponsor: National Institutes of Health Clinical Center (CC) (nih)
• Drugs / interventions: cyclophosphamide
• Locations: 1 site (Bethesda, Maryland)
• Trial ID: NCT05567198 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the effectiveness of Gonadotropin-releasing Hormone Agonist (GnRHa) in preserving ovarian function in women under 40 years old with Systemic Lupus Erythematosus (SLE) who are receiving cyclophosphamide (CYC) treatment. Participants will complete a one-time survey regarding their menstrual cycle and reproductive history, while also allowing for retrospective data collection from medical records. The study will compare ovarian function between those who received GnRHa alongside CYC and those who did not, providing insights into the protective effects of GnRHa during CYC therapy.

Who should consider this trial

Good fit: Ideal candidates are women under 40 years old with SLE who are starting CYC treatment.

Not a fit: Patients over 40 years old or those with a history of reproductive disorders or infertility may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help identify effective strategies to preserve fertility in young women with lupus undergoing chemotherapy.

How similar studies have performed: While the use of GnRHa for ovarian protection is suggested, there is limited data supporting its effectiveness, making this study a potentially novel approach.

Eligibility criteria

* 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.

Where this trial is running

Bethesda, Maryland

• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) — Bethesda, Maryland, United States (RECRUITING)

Study contacts

• Principal investigator: Sarfaraz A Hasni, M.D. — National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Study coordinator: Sarfaraz A Hasni, M.D.

Conditions: Systemic Lupus Erythematosus, Primary Ovarian Insufficiency, Nephritis, Neuro-Psychiatric Lupus, Anti-Mullerian Hormone, Natural History