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Effect of Prednisolone Treatment on Uterine Natural Killer Cells

Sponsor
Chinese University of Hong Kong (Other)
Overall Status
Recruiting
CT.gov ID
NCT03902912
Collaborator
(none)
84
Enrollment
1
Location
1
Arm
45
Anticipated Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 3

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
84 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
The participants will be invited to take prednisolone oral 10 mg/day and attend our outpaitent clinic to be performed endometrial biopsy.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)
Primary Purpose:
Treatment
Official Title:
Effect of Prednisolone Treatment on Uterine Natural Killer Cells and Endometrial Angiogenesis in Recurrent Miscarriage Around the Time of Embryo Implantation
Actual Study Start Date :
Jul 30, 2019
Anticipated Primary Completion Date :
Apr 30, 2022
Anticipated Study Completion Date :
Apr 30, 2023

Arms and Interventions

Arm Intervention/Treatment
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.

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.

Outcome Measures

Primary Outcome Measures

  1. the number of uNK cells [at the 1 day of endometrial biopsy]

    to investigate the association between uNK cells and prednisolone

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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,

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Chinese University of Hong Kong Hong Kong Hong Kong

Sponsors and Collaborators

  • Chinese University of Hong Kong

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chung Pui Wah Jacqueline, Associate Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT03902912
Other Study ID Numbers:
  • 2018.586
First Posted:
Apr 4, 2019
Last Update Posted:
Jul 29, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Chung Pui Wah Jacqueline, Associate Professor, Chinese University of Hong Kong
recurrent miscarriage
prednisolone treatment
Additional relevant MeSH terms:
Abortion, Spontaneous
Abortion, Habitual
Recurrence
Prednisolone

Study Results

No Results Posted as of Jul 29, 2020