Effect of Prednisolone Treatment on Uterine Natural Killer Cells
Primary Purpose
Recurrent Miscarriage
Status
Recruiting
Phase
Phase 3
Locations
Hong Kong
Study Type
Interventional
Intervention
Prednisolone
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Miscarriage focused on measuring recurrent miscarriage, prednisolone treatment
Eligibility Criteria
Inclusion Criteria:
- Women with a history of 3 or more consecutive miscarriages
- Women younger than 40 years old
Exclusion Criteria:
- Allergy to prednisolone
- Women who have any uterine anomaly
- Antiphospholipid syndrome
- Hydrosalpinx
- Thrombophilia
- Abnormal thyroid function tests
- women with diabetes,
Sites / Locations
- The Chinese University of Hong KongRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
prednisolone
Arm Description
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.
Outcomes
Primary Outcome Measures
the number of uNK cells
to investigate the association between uNK cells and prednisolone
Secondary Outcome Measures
Full Information
NCT ID
NCT03902912
First Posted
April 3, 2019
Last Updated
October 30, 2022
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT03902912
Brief Title
Effect of Prednisolone Treatment on Uterine Natural Killer Cells
Official Title
Effect of Prednisolone Treatment on Uterine Natural Killer Cells and Endometrial Angiogenesis in Recurrent Miscarriage Around the Time of Embryo Implantation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 30, 2019 (Actual)
Primary Completion Date
April 30, 2027 (Anticipated)
Study Completion Date
April 30, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study aims to investigate the role of uNK cells and the association with prednisolone.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Miscarriage
Keywords
recurrent miscarriage, prednisolone treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
The participants will be invited to take prednisolone oral 10 mg/day and attend our outpaitent clinic to be performed endometrial biopsy.
Masking
None (Open Label)
Allocation
N/A
Enrollment
84 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
prednisolone
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Prednisolone
Intervention Description
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.
Primary Outcome Measure Information:
Title
the number of uNK cells
Description
to investigate the association between uNK cells and prednisolone
Time Frame
at the 1 day of endometrial biopsy
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
This study is going to investigate the association between uterine natural killer cells and prednisolone. Therefore, only female will be recruit
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Women with a history of 3 or more consecutive miscarriages
Women younger than 40 years old
Exclusion Criteria:
Allergy to prednisolone
Women who have any uterine anomaly
Antiphospholipid syndrome
Hydrosalpinx
Thrombophilia
Abnormal thyroid function tests
women with diabetes,
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stacey Wong, BSc
Phone
85235051764
Email
staceywong@cuhk.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Pui Wah Jacqueline Chung, MBBS
Phone
85235051764
Email
jacquelinechung@cuhk.edu.hk
Facility Information:
Facility Name
The Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stacey Wong, BSc
Phone
85235051764
Email
staceywong@cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Pui Wah Jacqueline Chung, MBBS
Phone
85235051764
Email
jacquelinechung@cuhk.edu.hk
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effect of Prednisolone Treatment on Uterine Natural Killer Cells
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