Effect of Prednisolone Treatment on Uterine Natural Killer Cells

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

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

Study Overview

• Status: Recruiting
• Conditions: Recurrent Miscarriage
• Intervention / Treatment: Drug: 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.

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Stacey Wong, BSc; Phone Number: 85235051764; Email: staceywong@cuhk.edu.hk
• Study Contact Backup: Name: Pui Wah Jacqueline Chung, MBBS; Phone Number: 85235051764; Email: jacquelinechung@cuhk.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • The Chinese University of Hong Kong
    • Contact: Stacey Wong, BSc; Phone Number: 85235051764; Email: staceywong@cuhk.edu.hk
    • Contact: Pui Wah Jacqueline Chung, MBBS; Phone Number: 85235051764; Email: jacquelinechung@cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the number of uNK cells	to investigate the association between uNK cells and prednisolone	at the 1 day of endometrial biopsy

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2019
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2028

Study Registration Dates

• First Submitted: April 3, 2019
• First Submitted That Met QC Criteria: April 3, 2019
• First Posted (Actual): April 4, 2019

Study Record Updates

• Last Update Posted (Actual): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: recurrent miscarriage; prednisolone treatment
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Recurrence; Abortion, Spontaneous; Abortion, Habitual; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Prednisolone
• Other Study ID Numbers: 2018.586

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No