Effect of Prednisolone Treatment on Uterine Natural Killer Cells

Recurrent Miscarriage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03902912
• Other study ID #: 2018.586
• Status: Recruiting
• Phase: Phase 3
• Start date: July 30, 2019
• Est. completion date: April 30, 2028

Study information

• Verified date: November 2023
• Source: Chinese University of Hong Kong
• Contact: Stacey Wong, BSc
• Phone: 85235051764
• Email: staceywong[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: April 30, 2028
• Est. primary completion date: April 30, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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,

Related Conditions & MeSH terms

• Abortion, Habitual
• Abortion, Spontaneous
• Recurrence
• Recurrent Miscarriage

Intervention

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.

Locations

Country	Name	City	State
Hong Kong	The Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the number of uNK cells	to investigate the association between uNK cells and prednisolone	at the 1 day of endometrial biopsy