Effect of Fertility-sparing Therapy of Early Endometrial Cancer (ECFerSp)

Peking University

Status: Unknown

Conditions: Endometrial Cancer; Fertility

Treatments: Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT03538704

2018ECFerSp

Details and patient eligibility

About

The purpose of this study is to investigate the effect of Fertility-sparing Therapy of Early Endometrial Cancer.

Full description

This is a prospective, multi center, open, randomized, controlled clinical trial. All endometrial cancer (EC) or atypical hyperplasia (AH) patients who met the fertility-sparing indications in the hospitals involved in this study were recruited. Then the investigators conducted assessment, treatment and follow up according to the standard procedure. General information, therapeutic regimen, side effects, oncological and pregnant results were collected for risk factors analysis.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ages of no more than 40
• with a strong desire of fertility preservation
• International Federation of Gynecology and Obstetrics (FIGO) 2009 stage Ⅰa grade 1~2 with lesion confined in endometrium
• pathology expression of progestin receptors (PRs) and estrogen receptors

Exclusion criteria

• not eligible for pregnancy or delivery
• evidence of suspected extrauterine or distant metastasis
• complicated with any other malignancy
• severe medical complications
• contraindication of oral progestin
• uncontrolled epilepsy, central nervous system disease or mental disorder history in patients which Influence clinical research compliance judging by the researcher.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

BMI≥25 group with metformin

Experimental group

Description:

Patients with BMI≥25kg/m2 in the experimental group are treated with medroxyprogesterone acetate (MPA) 0.25g/d plus metformin and are followed-up of baseline data, hormone levels,

Treatment:

Drug: Metformin

BMI≥25 group without metformin

No Intervention group

Description:

Patients with BMI≥25kg/m2 in the none intervention group are treated with MPA 0.25g/d alone and are followed-up of baseline data, hormone levels, and endometrial pathology every 3 months until 12 months.