Trial | NCT03538704  Report issue

Official Title

Effect of Fertility-sparing Therapy of Early Endometrial Cancer

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    80
The purpose of this study is to investigate the effect of Fertility-sparing Therapy of Early Endometrial Cancer.
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.
Study Started
Jan 01
2015
Primary Completion
Mar 31
2020
Anticipated
Study Completion
Dec 31
2020
Anticipated
Last Update
May 29
2018

Drug Metformin

Metformin is given to patients 1-1.5g/d.

BMI≥25 group with metformin Experimental

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,

BMI≥25 group without metformin No Intervention

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.

Criteria 

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.
No Results Posted