To study the role of leuprolide acetate in reducing the deleterious effect of cyclophosphamide administration on the ovaries of patients with rheumatological diseases
- Conditions
- Health Condition 1: M30-M36- Systemic connective tissue disorders
- Registration Number
- CTRI/2023/11/060157
- Lead Sponsor
- Indian Council of Medical Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Adult (aged 18-39 years), post menarche but premenopausal females
2.Suffering from severe manifestations of systemic autoimmune rheumatic diseases (lupus, systemic vasculitis, systemic sclerosis, inflammatory myositis, sjogren’s syndrome, mixed connective tissue disease, overlap connective tissue disease, CTD-ILD, or autoimmune neurological diseases requiring cyclophosphamide including myelitis and peripheral neuropathies)
3.Planned for starting/recently started (within last 1 week) on intravenous cyclophosphamide therapy by the treating physician
1.Pregnancy or lactation
2.Evidence of pre-existing ovarian failure on gynecological evaluation and laboratory testing (baseline FSH >40 mIU/mL)
3.Prior oophorectomy, hysterectomy, or pelvic irradiation
4.Contraindications for use of GnRH analogues including hypersensitivity, undiagnosed abnormal vaginal bleeding, pregnancy or lactation
5.Use of Euro-Lupus regimen of intravenous cyclophosphamide
6.On hormonal contraceptives
7.Patients unwilling to provide written informed consent
8.Severe thrombocytopenia <50,000/uL (for intramuscular use of leuprolide)
9.Baseline AMH <1 ng/mL
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The compare the change in anti-mullerian hormone (AMH) levels from baseline at 6 months between patients receiving leuprolide acetate (with CYC) versus no leuprolide acetate (CYC alone)Timepoint: 6 months
- Secondary Outcome Measures
Name Time Method To compare the between-group change in antral follicular count (AFC), ovarian volume (OV), FSH and estradiol from baseline at 6, 12 and 18 monthsTimepoint: 6, 12 and 18 months;To compare the between-group rates of continuation/recovery of menstruation at 6, 12, and 18 monthsTimepoint: 6, 12 and 18 months;To compare the between-group rates of premature ovarian insufficiency at 12 and 18 monthsTimepoint: 12 and 18 months;To compare the change in AMH levels from baseline at 12 and 18 months between patients receiving leuprolide acetate with CYC versus CYC aloneTimepoint: 12 and 18 months;To examine the serious and non-serious adverse events related to leuprolide use during the study periodTimepoint: Throughout the study period (18 months)