MATERIALS AND METHODS
Study design and patients
This single-center, open-label,
randomized controlled phase II study (NCT03241888) was designed to
investigate the efficacy of oral MA+LNG-IUS or LNG-IUS alone compared
with oral MA alone as fertility-sparing treatment for AEH patients. This
work was conducted from July 21th, 2017, to June
18th, 2020, in Obstetrics and Gynecology Hospital of
Fudan University, Shanghai, China. This study was supported by the
National Key Research and Development Program of China (Grant No
2019YFC1005200 and 2019YFC1005204), Shanghai Medical Centre of Key
Programs for Female Reproductive Diseases (Grant No. 2017ZZ010616),
Shanghai sailing program (Grant No.19YF1404200) and Shen Kang clinical
project (SHDC22021219).
Eligible AEH patients met the following inclusion criteria were 18-45
years old; pathologically diagnosed with AEH for the first time by
endometrial biopsy through dilation and curettage with or without
hysteroscopy; with no signs of suspicious endometrial invasion or
extrauterine metastasis by transvaginal
ultrasonography; with the longest
uterine
diameter (from the fundus to endocervix) <7 cm by ultrasound
(as larger uterine cavity might lead to LNG-IUS expulsion or reduce the
treatment effect); with strong desire to preserve fertility; no
contraindication for progestin treatment or pregnancy; not pregnant when
participating in the trial; willing to follow the trial arrangement
after being fully informed of all the risks and inconveniences caused by
the trial.
Exclusion criteria were diagnosis of recurrent AEH, allergy history or
contraindications for MA or LNG-IUS; during pregnancy, severe infection,
severe chronic diseases (dysfunction of heart, liver, lung, or kidney),
high risk of thrombosis, receiving hormone treatment for more than three
months within six months before entering the trial, other malignancy
history, concurrent malignancy in genital or other systems.
Pathologic diagnosis was confirmed by two experienced gynecological
pathologists (Dr. Zhu Q and Dr. Zhou XR), according to the World Health
Organization (WHO) pathological classification (2014)23. If their opinions differed, a seminar was held in
the pathological department for the final diagnosis.
The trial was approved by the
Institutional Review Board of the Obstetrics and Gynecology Hospital,
Fudan University (Approval No.: 2017-30), and all patients were fully
informed of the benefits and risks of this clinical trial and provided
written informed consent.