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Recruiting NCT03902912

Effect of Prednisolone Treatment on Uterine Natural Killer Cells

Phase III Interventional Recurrent Miscarriage

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Prednisolone.
Who it may be relevant to
Registry conditions: Recurrent Miscarriage. Basic parameters: 18 years — 40 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effect of Prednisolone Treatment on Uterine Natural Killer Cells and Endometrial Angiogenesis in Recurrent Miscarriage Around the Time of Embryo Implantation

Overview

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.

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.

Primary outcome measures

  • the number of uNK cells [Time frame: at the 1 day of endometrial biopsy]

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,

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Hong Kong · 1 center
  • The Chinese University of Hong Kong — Hong Kong

Identifiers

NCT: NCT03902912 · 2018.586

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗