Adenomyosis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosed as DAD by ultrasound or MR, and the uterine volume calculated by the three diameters of the uterus under ultrasound is between 130 and 355 ml (the uterus is equivalent to the size of 8 to 14 weeks of pregnancy). 2. Menstrual volume > 80 ml, or dysmenorrhea or pelvic pain with a Visual Analogue Scale (VAS) score >= 6. 3. Aged between 18 and 50 years old, without contraindications to surgical operations. Except for correcting anemia by supplementing iron agents and/or treating dysmenorrhea with non-steroidal anti-inflammatory drugs (NSAIDs), no other medications have been used in the past three months. 4. For those with fertility requirements, the following conditions need to be met: 1) Age = 2 times, and the cause of infertility is mainly DAD as evaluated by a reproductive physician. 3) For those with decreased ovarian reserve function (AMH < 1.1 ng/ml), it is recommended to preserve fertility by freezing embryos through IVF first. 5.The patient agrees to participate in this clinical study, voluntarily signs the informed consent form, and consents to participate in all the follow-up visits, examinations and treatments as required by the research protocol.
Exclusion criteria
Exclusion criteria: 1. Age > 50 years old and entering the perimenopausal period, with no significance in preserving the uterus. 2.Clinically suspected of malignant diseases of the cervix or uterine body, malignant tumors of the ovaries and fallopian tubes, etc. 3.Those who need to take estrogen antagonists for a long time after the operation of breast malignant tumor. 4.Patients with severe primary diseases such as cardiovascular and cerebrovascular, urogenital and hematopoietic systems, malignant tumors, other serious comorbidities or mental illnesses. 5. In the acute phase of any systemic inflammation; Pregnancy, lactation or with other malignant tumors. 6. Asymptomatic DAD. 7.Having participated in other clinical trials for the treatment of DAD within the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dysmenorrhea score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Life quality score;Recurrence rate;The condition of the fallopian tubes' patency;Uterine volume;Menstrual flow volume PBAC score;Classification of uterine adenomyosis;Pregnancy mode (natural/IVF-ET), clinical pregnancy rate, miscarriage rate, preterm birth, full-term birth, delivery method, presence or absence of uterine rupture;Hemoglobin, CA125/CA199;Adverse event;Uterine cavity condition;The recovery of blood flow in the uterine muscle layer; | — |
Countries
China
Contacts
Peking University Shenzhen Hospital