Actively Recruiting
Effect of Prednisolone Treatment on Uterine Natural Killer Cells and Endometrial Angiogenesis in Recurrent Miscarriage Around the Time of Embryo Implantation
Led by Chinese University of Hong Kong · Updated on 2025-03-21
84
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
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 prednisolone's 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 mg/day for 3 days, then 2 mg/day for 3 days, and finally 1 mg/day 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.
CONDITIONS
Brief Title
Effect of Prednisolone Treatment on Uterine Natural Killer Cells
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women with a history of 3 or more consecutive miscarriages
- Women younger than 40 years old
You will not qualify if you...
- Allergy to prednisolone
- Women who have any uterine anomaly
- Antiphospholipid syndrome
- Hydrosalpinx
- Thrombophilia
- Abnormal thyroid function tests
- Women with diabetes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 4 weeks
Participants take prednisolone oral 10 mg/day from day one of the menstrual cycle to day LH plus 7, followed by tapering doses over 9 days.
Weekly visits for medication monitoring and endometrial biopsy
Trial Site Locations
Total: 1 location
1
The Chinese University of Hong Kong
Hong Kong, Hong Kong
Actively Recruiting
Research Team
S
Stacey Wong, BSc
P
Pui Wah Jacqueline Chung, MBBS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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