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Effect of Prednisolone Treatment on Uterine Natural Killer Cells

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03902912
Recruitment Status : Recruiting
First Posted : April 4, 2019
Last Update Posted : July 29, 2020
Sponsor:
Information provided by (Responsible Party):
Chung Pui Wah Jacqueline, Chinese University of Hong Kong

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

Condition or disease Intervention/treatment Phase
Recurrent Miscarriage Drug: Prednisolone 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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 : July 30, 2019
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : April 30, 2023


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.




Primary Outcome Measures :
  1. the number of uNK cells [ Time Frame: at the 1 day of endometrial biopsy ]
    to investigate the association between uNK cells and prednisolone



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   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
Accepts Healthy Volunteers:   Yes
Criteria

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,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03902912


Contacts
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Contact: Hiu Tan Margaret Lee 85235051764 margaretlee@cuhk.edu.hk
Contact: Pui Wah Jacqueline Chung, MBBS 85235051764 jacquelinechung@cuhk.edu.hk

Locations
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Hong Kong
The Chinese University of Hong Kong Recruiting
Hong Kong, Hong Kong
Contact: Hiu Tan Margaret Lee    85235051764    margaretlee@cuhk.edu.hk   
Contact: Pui Wah Jacqueline Chung, MBBS    85235051764    jacquelinechung@cuhk.edu.hk   
Sponsors and Collaborators
Chinese University of Hong Kong
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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: April 4, 2019    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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, Chinese University of Hong Kong:
recurrent miscarriage
prednisolone treatment
Additional relevant MeSH terms:
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Abortion, Spontaneous
Abortion, Habitual
Pregnancy Complications
Prednisolone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents