Investigating the effects of prednisolone on uterine natural killer cells in women with recurrent miscarriage
Effect of Prednisolone Treatment on Uterine Natural Killer Cells and Endometrial Angiogenesis in Recurrent Miscarriage Around the Time of Embryo Implantation
This study is testing if taking prednisolone can help women who have had multiple miscarriages by looking at how it affects certain immune cells in their uterus.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT03902912 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the impact of prednisolone, a glucocorticoid, on uterine natural killer (uNK) cells in women who have experienced recurrent miscarriages. Participants will receive an oral dose of 10 mg/day of prednisolone and will undergo endometrial biopsies at an outpatient clinic to assess the treatment's effects. The study seeks to clarify the inconclusive evidence surrounding prednisolone as a potential therapy for recurrent miscarriage and to understand the underlying mechanisms involved.
Who should consider this trial
Good fit: Ideal candidates are women under 40 years old with a history of three or more consecutive miscarriages.
Not a fit: Patients with allergies to prednisolone or specific uterine anomalies, as well as those with certain medical conditions like antiphospholipid syndrome or diabetes, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve pregnancy outcomes for women with a history of recurrent miscarriages.
How similar studies have performed: While the evidence for prednisolone treatment in this context is inconclusive, similar studies have explored its effects, indicating a need for further investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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,
Where this trial is running
Hong Kong
- The Chinese University of Hong Kong — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Study coordinator: Stacey Wong, BSc
- Email: staceywong@cuhk.edu.hk
- Phone: 85235051764
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.