Effect of Prednisolone Treatment on Uterine Natural Killer Cells

NCT ID: NCT03902912

Last Updated: 2025-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-30

Study Completion Date

2028-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Recurrent Miscarriage

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The participants will be invited to take prednisolone oral 10 mg/day and attend our outpaitent clinic to be performed endometrial biopsy.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Prednisolone

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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,
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Chung Pui Wah Jacqueline

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Chinese University of Hong Kong

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Stacey Wong, BSc

Role: CONTACT

85235051764

Pui Wah Jacqueline Chung, MBBS

Role: CONTACT

85235051764

Facility Contacts

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Stacey Wong, BSc

Role: primary

85235051764

Pui Wah Jacqueline Chung, MBBS

Role: backup

85235051764

Other Identifiers

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2018.586

Identifier Type: -

Identifier Source: org_study_id

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