Effect of Prednisolone Treatment on Uterine Natural Killer Cells

NCT03902912 | Recruiting Phase 3 DMC

• 1 other identifier: 2018.586
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Recurrent Miscarriage

Keywords

recurrent miscarriage; prednisolone treatment

Outcome Measures

Primary Outcomes (1)

• the number of uNK cells

  to investigate the association between uNK cells and prednisolone

  at the 1 day of endometrial biopsy

Study Arms (1)

prednisolone

EXPERIMENTAL

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

Interventions

Prednisolone 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.

prednisolone

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: This study is going to investigate the association between uterine natural killer cells and prednisolone. Therefore, only female will be recruit
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women with a history of 3 or more consecutive miscarriages
• Women younger than 40 years old

You may not qualify if:

• Allergy to prednisolone
• Women who have any uterine anomaly
• Antiphospholipid syndrome
• Hydrosalpinx
• Thrombophilia
• Abnormal thyroid function tests
• women with diabetes,

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Abortion, Habitual

Interventions

Prednisolone

Condition Hierarchy (Ancestors)

Abortion, Spontaneous; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Stacey Wong, BSc

CONTACT

85235051764; staceywong@cuhk.edu.hk

Pui Wah Jacqueline Chung, MBBS

CONTACT

85235051764; jacquelinechung@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The participants will be invited to take prednisolone oral 10 mg/day and attend our outpaitent clinic to be performed endometrial biopsy.

Study Record Dates

• First Submitted: April 3, 2019
• First Posted: April 4, 2019
• Study Start: July 30, 2019
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2028
• Last Updated: March 21, 2025

Record last verified: 2025-03

Locations

HK (1)