The purpose of this study is to initially explore the efficacy of adipose-derived stromal vascular fraction (AD-SVF) therapy in the treatment of refractory endometrial infertility.
Patients with refractory thin endometrium (endometrial thickness \< 6 mm at late proliferative phase or after high-dose estrogen therapy) and/or moderate to severe intrauterine adhesion are recruited for fertility. After detailed explanation of the treatment plan, written informed consent will be obtained from the patients. The subjects undergo liposuction performed by plastic surgeons to obtain adipose tissue, from which AD-SVF is isolated and extracted for intrauterine infusion therapy. Six months post-AD-SVF treatment, the improvement in menstrual volume and endometrial thickness will be assessed during follow-up visits. The subjects will be advised, based on their personal inclination, to attempt conception (hysteroscopic surgery will be repeated if necessary), and their early pregnancy outcomes will be documented in subsequent follow-ups.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
AD-SVF is isolated and extracted from adipose tissue for intrauterine infusion therapy.
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
RECRUITINGProportion of patients with endometrial thickness of 6 mm or greater
During the late proliferative phase, the endometrial thickness between anterior and posterior uterine walls is measured to be at least 6 mm through a median sagittal section of the uterus at least once.
Time frame: 6 months after AD-SVF intrauterine infusion therapy
Menstrual flow score at the 2nd month post-treatment
2 months after treatment, menstrual flow is scored according to the Pictorial Blood-loss Assessment Chart, with scores ranging from 0 to 100, and higher scores indicate better outcomes.
Time frame: 2 months after AD-SVF intrauterine infusion therapy
Menstrual flow score at the 6th month post-treatment
6 months after treatment, menstrual flow is scored according to the Pictorial Blood-loss Assessment Chart, with scores ranging from 0 to 100, and higher scores indicate better outcomes.
Time frame: 6 months after AD-SVF intrauterine infusion therapy
Chemical pregnancy
Serum β-HCG ≥ 10 mIU/mL is detected at least 30 days after menstruation.
Time frame: 9 months after AD-SVF intrauterine infusion therapy
Clinical pregnancy
Ultrasound indicates the presence of a gestational sac and fetal heartbeat in the uterine cavity Ultrasound indicates the presence of a gestational sac and fetal heartbeat in the uterine cavity Ultrasound indicates the presence of a gestational sac and fetal heartbeat in the uterine cavity at 6-8 weeks of gestation.
Time frame: 9 months after AD-SVF intrauterine infusion therapy
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