Study of Prednisolone Treatment on Uterine Natural Killer Cells and Blood Vessel Growth in Women With Recurrent Miscarriage

What this Trial Is About

This trial studies women with recurrent miscarriage to understand how uterine natural killer uNK cells may be affected by treatment with prednisolone, a type of glucocorticoid. Researchers want to explore whether prednisolone influences uNK cells and endometrial blood vessel growth around the time when an embryo implants. The study is a phase 3 clinical trial led by the Chinese University of Hong Kong, aiming to clarify prednisolones role and mechanism in this condition. Participants will take prednisolone orally at a dose of 10 mg daily starting from the first day of their next menstrual cycle until seven days after the luteinizing hormone LH surge. Afterwards, the dose will be gradually reduced over nine days 5 mgday for 3 days, then 2 mgday for 3 days, and finally 1 mgday for 3 days. During this period, participants will attend outpatient clinic visits where an endometrial biopsy will be performed to collect tissue samples. Throughout the study, researchers will assess the number of uterine natural killer cells at the time of the endometrial biopsy. Participants will undergo evaluations including clinical visits and biopsy procedures to monitor the effects of the medication. The total duration of participation depends on the menstrual cycle timing, with safety and response monitored closely during the treatment and biopsy periods.

Effect of Prednisolone Treatment on Uterine Natural Killer Cells