Effect of Prednisolone Treatment on Uterine Natural Killer Cells

Overview

This study aims to investigate the role of uNK cells and its association with prednisolone.

Full Title of Study: “Effect of Prednisolone Treatment on Uterine Natural Killer Cells and Endometrial Angiogenesis in Recurrent Miscarriage Around the Time of Embryo Implantation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 30, 2022

Detailed Description

Glucocorticoids prednisolone is considered as a potential therapy in women with recurrent miscarriage. However, the evidence for treatment with prednisolone is still inconclusive and the relevant mechanism merits further investigations. The participants will be invited to take prednisolone oral 10 mg/day and attend our outpaitent clinic to be performed endometrial biopsy.

Interventions

  • Drug: Prednisolone
    • prednisolone oral 10 mg/day from day one of the subsequent menstrual cycle to day LH 7 of that cycle. Then, the participants will be given a tailing off dose of 5 mg/day for 3 days followed by 2 mg/day for 3 days and then 1 mg/day for 3 days.

Arms, Groups and Cohorts

  • Experimental: prednisolone
    • prednisolone oral 10 mg/day from day one of the subsequent menstrual cycle to day LH plus 7. Women will be then given a tailing off dose of 5 mg/day for 3 days followed by 2 mg/day for 3 days and then 1 mg/day for 3 days.

Clinical Trial Outcome Measures

Primary Measures

  • the number of uNK cells
    • Time Frame: at the 1 day of endometrial biopsy
    • to investigate the association between uNK cells and prednisolone

Participating in This Clinical Trial

Inclusion Criteria

1. Women with a history of 3 or more consecutive miscarriages 2. Women younger than 40 years old Exclusion Criteria:

1. Allergy to prednisolone 2. Women who have any uterine anomaly 3. Antiphospholipid syndrome 4. Hydrosalpinx 5. Thrombophilia 6. Abnormal thyroid function tests 7. women with diabetes,

Gender Eligibility: Female

This study is going to investigate the association between uterine natural killer cells and prednisolone. Therefore, only female will be recruit

Minimum Age: 18 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Chinese University of Hong Kong
  • Provider of Information About this Clinical Study
    • Principal Investigator: Chung Pui Wah Jacqueline, Associate Professor – Chinese University of Hong Kong
  • Overall Contact(s)
    • Hiu Tan Margaret Lee, 85235051764, margaretlee@cuhk.edu.hk

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