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

KK Women's and Children's Hospital

Status and phase: Enrolling; Phase 2

Conditions: Disease Regression; Treatment Side Effects; Endometrial Hyperplasia; Fertility Issues

Treatments: Drug: Megace; Drug: Mirena

Study type: Interventional

Funder types: Other

Identifiers

NCT05492487

CIRB 2019/2551

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 21 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Mirena Arm

Experimental group

Description:

The patients in the Mirena arm will have a Mirena inserted at time of recruitment of the study. An endometrial biopsy will be performed to assess for disease progression, regression or persistence after 3 months. The endometrial biopsy will be performed via bedside endometrial sampling or hysteroscopic biopsy. As Mirena can be used for treatment of atypical hyperplasia as well as endometrial protection (decreases the risk of endometrial hyperplasia recurrence), the option of keeping or changing the Mirena during biopsy will be discussed with the patient.

Treatment:

Drug: Mirena

Megace Arm

Experimental group

Description:

The patients in the megace arm will have be prescribed 3 months of oral megace at time of recruitment of the study. An endometrial biopsy will be performed to assess for disease progression, regression or persistence after 3 months. The endometrial biopsy will be performed via bedside endometrial sampling or hysteroscopic biopsy.

Treatment:

Drug: Megace