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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

* 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 it's running

• 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.
• Email: hasnisa@mail.nih.gov
• Phone: (301) 451-1599

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.