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Effect of Prednisolone Treatment on Uterine Natural Killer Cells

Phase 3
Recruiting
Conditions
Recurrent Miscarriage
Interventions
Registration Number
NCT03902912
Lead Sponsor
Chinese University of Hong Kong
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.

Recruitment & Eligibility

Status
RECRUITING
Sex
Female
Target Recruitment
84
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,

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
prednisolonePrednisoloneprednisolone 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.
Primary Outcome Measures
NameTimeMethod
the number of uNK cellsat the 1 day of endometrial biopsy

to investigate the association between uNK cells and prednisolone

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

The Chinese University of Hong Kong

🇭🇰

Hong Kong, Hong Kong

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