Immunomodulatory Therapy to Restore Ovarian Function and Improve Fertility in Women With Autoimmune Premature Ovarian Insufficiency

Exclusion Criteria

• •1. Hypersensitivity to rituximab, any of the AxMPs, or any of the excipients (as detailed in the SmPC for the various IMPs)
• •2. Active, severe infection or JCV positivity
• •3. Active hepatitis B infection
• •4. Severe immunosuppression
• •5. Severe cardiac disease
• •6. Cancer
• •7. Benign tumours of the hypothalamus, pituitary, or ovarian pathology
• •8. Vaginal bleeding of unknown etiology
• •9. Hormone replacement therapy within four weeks prior study entry
• •10. Pregnant or lactating women
• •11. Concurrent treatment with other immunosuppressive drugs
• •12. Any vaccination within 4 weeks of infusion of study medication
• •13. Severe psychiatric disorder
• •14. Any condition or any circumstance that in the opinion of the investigator would make it unsafe to undergo treatment with rituximab or controlled ovarian hyperstimulation
• •15. Active thrombolic disorder (contraindicated for Ovirelle)
• •16. Moderate or severe impairment of kidney or liver function (contraindicated for Orgalutran)
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