A Pilot Study on Fertility Conservative Treatment of Atypical Endometrial Hyperplasia in Singapore

Last updated: August 5, 2022
Sponsor: KK Women's and Children's Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Endometrial Hyperplasia

Endometriosis

Infertility

Treatment

N/A

Clinical Study ID

NCT05492487
CIRB 2019/2551
  • Ages 21-40
  • Female

Study Summary

The investigators' objective is to determine the regression rate, side effects and acceptability of Mirena compared to megace in the treatment of atypical endometrial hyperplasia among women desiring fertility.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All women diagnosed with atypical hyperplasia aged 21 years to 40 years
  • Keen for fertility-preserving treatment

Exclusion

Exclusion Criteria:

  • Patients who are currently undergoing treatment for atypical hyperplasia
  • Patients with a history of endometrial carcinoma

Study Design

Total Participants: 60
Study Start date:
January 03, 2020
Estimated Completion Date:
March 31, 2023

Study Description

Atypical endometrial hyperplasia is a growing clinical problem that increases the risk of carcinogenesis and negatively impacts fertility. Although oral medical treatment may lead to regression in up to 90% of patients, they are associated with adverse side effects such as weight gain, that negatively affects fertility. To-date, there has been no RCTs evaluating the performance of the Mirena Intrauterine System (IUS) with megestrol acetate (megace) (the most effective and commonly used progestogen) in treating women with atypical hyperplasia who still desire fertility.

Connect with a study center

  • KK Women's and Children's Hospital

    Singapore, 229899
    Singapore

    Active - Recruiting

  • National University Hospital

    Singapore, 119074
    Singapore

    Active - Recruiting

  • Singapore General Hospital

    Singapore, 169608
    Singapore

    Active - Recruiting

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