Recurrent MiscarriagePhase 3NCT03902912
Effect of Prednisolone Treatment on Uterine Natural Killer Cells
A Phase 3 study testing Prednisolone in people with Recurrent Miscarriage, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
This study aims to investigate the role of uNK cells and the association with prednisolone. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Recurrent Miscarriage
- What is being tested?
- Prednisolone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteHong Kong
- Study dates
- 30 Jul 2019to 30 Apr 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women with a history of 3 or more consecutive miscarriages
- Women younger than 40 years old
Who cannot join
- Allergy to prednisolone
- Women who have any uterine anomaly
- Antiphospholipid syndrome
- Hydrosalpinx
- Thrombophilia
- Abnormal thyroid function tests
- women with diabetes,
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The Chinese University of Hong Kong
Hong Kong
Stacey Wong, BSc, 85235051764, staceywong@cuhk.edu.hk
Pui Wah Jacqueline Chung, MBBS, 85235051764, jacquelinechung@cuhk.edu.hk
About this study
Official title: 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.
Read the 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.
- Conditions
- Recurrent Miscarriage
- Being tested
- Prednisolone
- Keywords
- recurrent miscarriage, prednisolone treatment
- Medical subject headings
- Abortion, Habitual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoloneDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| prednisolone | Experimental | 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. Receives: Drug: Prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of uNK cells
to investigate the association between uNK cells and prednisolone
Measured: at the 1 day of endometrial biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start30 Jul 2019
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent MiscarriageStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The participants will be invited to take prednisolone oral 10 mg/day and attend our outpaitent clinic to be performed endometrial biopsy.
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chung Pui Wah Jacqueline, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03902912
- Sponsor's protocol ID
- 2018.586
- Status last verified
- Mar 2025
- First submitted
- 3 Apr 2019
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prednisolone Treatment on Uterine Natural Killer Cells and Endometrial Angiogenesis in Recurrent Miscarriage Around the Time of Embryo Implantation
- ClinicalTrials.gov ID
- NCT03902912
- Acronym / sponsor ID
- 2018.586
- Conditions
- Recurrent Miscarriage
- Keywords
- recurrent miscarriage, prednisolone treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 30 Jul 2019 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 4 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate the role of uNK cells and the association with 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The participants will be invited to take prednisolone oral 10 mg/day and attend our outpaitent clinic to be performed endometrial biopsy.
| Arm | Type | Receives |
|---|---|---|
| prednisolone | Experimental | Drug: Prednisoloneprednisolone 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women with a history of 3 or more consecutive miscarriages
- Women younger than 40 years old
Key exclusion criteria (7 listed)
- Allergy to prednisolone
- Women who have any uterine anomaly
- Antiphospholipid syndrome
- Hydrosalpinx
- Thrombophilia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prednisoloneprednisolone 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. | Drug | prednisolone |
Primary outcome
the number of uNK cells
Time frame: at the 1 day of endometrial biopsy
to investigate the association between uNK cells and prednisolone
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Prednisolone in people with Recurrent Miscarriage, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stacey Wong, BSc (85235051764, staceywong@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the number of uNK cells (time frame: at the 1 day of endometrial biopsy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.