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NCT Number: NCT03902912

Effect of Prednisolone Treatment on Uterine Natural Killer Cells

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

Recruiting

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Key information

Conditions

Recurrent Miscarriage Abortion, Habitual Abortion, Spontaneous Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women with a history of 3 or more consecutive miscarriages
  • Women younger than 40 years old

Exclusion criteria

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

Treatment and study plan

Prednisolone

Drug

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.

Primary outcomes

  1. the number of uNK cells

    Time frame: at the 1 day of endometrial biopsy

    to investigate the association between uNK cells and prednisolone

Study contacts

Contact information is provided by the study sponsor or research team.

Pui Wah Jacqueline Chung, MBBS

CONTACT

[email protected]

85235051764

Stacey Wong, BSc

CONTACT

[email protected]

85235051764

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2027
Study completion
2028
First posted
Apr 4, 2019
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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