Hysteroscopic Suture Fixation of Mirena in the Treatment of Adenomyosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-55
SponsorFirst People's Hospital of Hangzhou
About this trial
The purpose of this study was to evaluate the efficacy and safety of hysteroscopic Mirena fixation in patients with adenomyosis with enlarged uterus, compared with simple Mirena placement under hysteroscopy. Whether the curative effect is not inferior to and reduces the incidence of Mirena expulsion.
Eligibility criteria
Qualifiers
Pain due to adenomyosis (lower abdominal pain and low back pain) visual analogue scale (VAS) ≥40mm or menstrual volume score (PBAC) ≥100;
Adenomyosis was confirmed by ultrasound or magnetic resonance imaging (MRI);
The uterine volume measured by transvaginal gynecological three-dimensional ultrasound was more than 150cm3 and less than 280cm3 (the volume was about 280cm3 at 10 weeks of pregnancy); ④ A strong desire to preserve the uterus; ⑤ No fertility requirements within nearly one year;
Premenopausal women aged ≥18 years old; ⑦ Willing and able to abide by the study protocol, and have the ability to clearly judge the amount of menstruation and the degree of pain.
Disqualifiers
Presence of contraindications to Mirena (known or suspected pregnancy, current pelvic inflammatory disease or recurrent pelvic inflammatory disease, lower genital tract infection, postpartum endometritis, infectious abortion within the past 3 months, cervicitis, cervical dysplasia, uterine or cervical malignant lesions, progestin-dependent tumors, abnormal uterine bleeding of unknown cause, congenital or acquired uterine abnormalities, these include fibroids that deform the cervix, conditions that increase susceptibility to infections, acute liver diseases or tumours, allergy to active ingredients or excipient);
Malignant tumors (including reproductive system and other systems);
Acute stage of heart, liver and kidney failure or other patients who cannot tolerate operation;
The history of Mirena displacement or expulsion;
Trial design
Treatments tested in this trial
- A:hysteroscopic suture fixation of Mirena
- A: simple Mirena placement under hysteroscopy
- B: hysteroscopic suture fixation of Mirena
- B：simple Mirena placement under hysteroscopy
Treatment groups
144 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov