Effect of Prednisolone Treatment on Uterine Natural Killer Cells

The Chinese University of Hong Kong

Status and phase: Enrolling; Phase 3

Conditions: Recurrent Miscarriage

Treatments: Drug: Prednisolone

Study type: Interventional

Funder types: Other

Identifiers

NCT03902912

2018.586

Details and patient eligibility

About

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

Full 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.

Enrollment: 84 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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,

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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84 participants in 1 patient group

prednisolone

Experimental group

Description:

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.

Treatment:

Drug: Prednisolone