Actively Recruiting

Phase 3
Age: 18Years - 40Years
FEMALE
Healthy Volunteers
ID03902912

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

Led by Chinese University of Hong Kong · Updated on 2025-03-21

84

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This trial studies women with recurrent miscarriage to understand how uterine natural killer (uNK) cells may be affected by treatment with prednisolone, a type of glucocorticoid. Researchers want to explore whether prednisolone influences uNK cells and endometrial blood vessel growth around the time when an embryo implants. The study is a phase 3 clinical trial led by the Chinese University of Hong Kong, aiming to clarify prednisolone's role and mechanism in this condition. Participants will take prednisolone orally at a dose of 10 mg daily starting from the first day of their next menstrual cycle until seven days after the luteinizing hormone (LH) surge. Afterwards, the dose will be gradually reduced over nine days (5 mg/day for 3 days, then 2 mg/day for 3 days, and finally 1 mg/day for 3 days). During this period, participants will attend outpatient clinic visits where an endometrial biopsy will be performed to collect tissue samples. Throughout the study, researchers will assess the number of uterine natural killer cells at the time of the endometrial biopsy. Participants will undergo evaluations including clinical visits and biopsy procedures to monitor the effects of the medication. The total duration of participation depends on the menstrual cycle timing, with safety and response monitored closely during the treatment and biopsy periods.

CONDITIONS

Brief Title

Effect of Prednisolone Treatment on Uterine Natural Killer Cells

Who Can Participate

Age: 18Years - 40Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Women with a history of 3 or more consecutive miscarriages
  • Women younger than 40 years old
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 4 weeks

Participants take prednisolone oral 10 mg/day from day one of the menstrual cycle to day LH plus 7, followed by tapering doses over 9 days.

Weekly visits for medication monitoring and endometrial biopsy

Trial Site Locations

Total: 1 location

1

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Actively Recruiting

Loading map...

Research Team

S

Stacey Wong, BSc

P

Pui Wah Jacqueline Chung, MBBS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Similar Trials

Is Plasma Level of Mannose Binding Lectin Associated With Re...

Mannose-Binding Lectin Deficiency

Actively Recruiting

1 location

The Prevalence of Chronic Endometritis and Therapeutic Benef...

Recurrent Miscarriage

Actively Recruiting

1 location

Analysis of Immune Cell Populations in the Endometrium and P...

Infertility, Female

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here