Levonorgestrel-releasing intrauterine device plus metformin, or megestrol acetate plus metformin for fertility-sparing treatment of atypical endometrial hyperplasia and early endometrial carcinoma: a prospective, randomized, blind-endpoint design trial protocol

Table 1 Schedule of patient assessments

	Baseline	Day 1	3 months (± 14 days)	6 months (± 14 days)	9 months (± 14 days)	12 months (± 14 days)	18 months (± 14 days)	24 months (± 14 days)
Assessment
Informed consent	√
CT of pelvis/abdomen^a	√			√		√	√	√
CT chest (or chest X-ray)	√			√		√	√	√
MRI of pelvis	√			√		√	√	√
Pelvic ultrasonography^b	√		√	√	√	√	√	√
CA125	√		√	√	√	√	√	√
FBG (fasting blood-glucose)	√		√	√	√	√	√	√
Serum or urine pregnancy test	√	√(urine)
Fasting blood sugar	√		√	√	√	√	√	√
HbA1c	√		√	√	√	√	√	√
HE4 (human epididymal protein4)	√		√	√	√	√	√	√
Blood collection for biomarkers and genetic testing	√
ERα, PRα and PRβ (estrogen receptor, progesterone receptor)	√
Medical history	√
Concomitant medications	√		√	√	√	√	√	√
ECOG	√		√	√	√	√	√	√
Height	√
Weight	√		√	√	√	√	√	√
BMI	√		√	√	√	√	√	√
Surgical, medical, gynecologic, and family history	√
Self-efficacy and social support questionnaire	√		√	√	√	√	√	√
Adverse events			√	√	√	√	√	√
Hysteroscopy, D&C			√	√	√	√	√	√
Intervention adherence			√	√	√	√	√	√

BMI body mass index, CA125 cancer antigen 125, CT computed tomography, D&C dilation and curettage, ECOG Eastern Cooperative Oncology Group, HbA1c glycosylated hemoglobin, MRI magnetic resonance imaging
^aCT scans will be performed every 6 months. However, if the ultrasound shows obvious lesions in the uterine cavity and tissue pathological examination indicates no remission or the disease has progressed, additional CT examination will be performed
^bPatients will receive pelvic ultrasonography and hysteroscopic and curettage every 3 months for endometrial pathological examination. If the ultrasound shows obvious lesions in the uterine cavity and tissue pathological examination indicates no remission or the disease has progressed, additional CT/MRI examination will be performed

ISSN: 1742-4755