AdenomyosisNCT06478992
Hysteroscopic Suture Fixation of Mirena in the Treatment of Adenomyosis
A study testing A:hysteroscopic suture fixation of Mirena, A: simple Mirena placement under hysteroscopy and B: hysteroscopic suture fixation of Mirena in people with Adenomyosis and Hysteroscopy, run by First People's Hospital of Hangzhou.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Adenomyosis, Hysteroscopy
- What is being tested?
- A:hysteroscopic suture fixation of Mirena, A: simple Mirena placement under hysteroscopy and B: hysteroscopic suture fixation of Mirena
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
- Ultrasound showed the presence of ovarian chocolate cyst; ⑥ The presence of deep endometrial nodules by gynecological examination;
- The presence of intramural or subserous myoma ≥3cm or any size of uterine submucosal myoma (type 0, 1, 2); ⑧ Patients who are unwilling to participate in the study or who were considered by the investigators to be unsuitable for the study.
About this study
Official title: A Multicenter Randomized Controlled Trial of Hysteroscopic Suture Fixation of Mirena in the Treatment of Adenomyosis
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.
Read the detailed description
This study was a multicenter, randomized (1:1 allocation to each group), double-blind, parallel controlled trial.
- Conditions
- Adenomyosis, Hysteroscopy
- Being tested
- A:hysteroscopic suture fixation of Mirena, A: simple Mirena placement under hysteroscopy, B: hysteroscopic suture fixation of Mirena, B：simple Mirena placement under hysteroscopy
- Keywords
- Suture fixation, Expulsion, Mirena, Adenomyosis
- Medical subject headings
- Adenomyosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A:hysteroscopic suture fixation of MirenaProcedure or surgery
A(the thickness of the thickest uterine myometrium ≥30mm ):The Mirena is fixed to the uterine wall under hysteroscopy, and the endometrial tissue was routinely aspirated and scraped during the operation and sent for pathological examination.
A: simple Mirena placement under hysteroscopyProcedure or surgery
A(the thickness of the thickest uterine myometrium ≥30mm):Mirena is routinely placed in the uterine cavity under hysteroscopy, and endometrial tissue was routinely aspirated and scraped during the operation and sent for pathological examination.
B: hysteroscopic suture fixation of MirenaProcedure or surgery
B(the thickness of the thickest uterine myometrium<30mm):The Mirena is fixed to the uterine wall under hysteroscopy, and the endometrial tissue was routinely aspirated and scraped during the operation and sent for pathological examination.
B：simple Mirena placement under hysteroscopyProcedure or surgery
B(the thickness of the thickest uterine myometrium<30mm):Mirena is routinely placed in the uterine cavity under hysteroscopy, and endometrial tissue was routinely aspirated and scraped during the operation and sent for pathological examination.
| Study group | Role | What they receive |
|---|---|---|
| the thickness of the thickest uterine myometrium ≥30mm | Other | Not described Receives: Procedure: A:hysteroscopic suture fixation of Mirena; Procedure: A: simple Mirena placement under hysteroscopy |
| the thickness of the thickest uterine myometrium <30mm | Other | Not described Receives: Procedure: B: hysteroscopic suture fixation of Mirena; Procedure: B：simple Mirena placement under hysteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
expulsion rate of the Mirena
Measured: 1, 3, 6, and 12 months postoperatively
Secondary outcomes (3)
menstrual volume
Measured: 1, 3, 6, and 12 months postoperatively
dysmenorrhea
Measured: 1, 3, 6, and 12 months postoperatively
uterine size under ultrasound
Measured: 1, 3, 6, and 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start30 Jun 2024 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenomyosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Hangzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06478992
- Sponsor's protocol ID
- IIT-20220610-0097-02
- Status last verified
- Jun 2024
- First submitted
- 23 Jun 2024
- Last updated
- 27 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Controlled Trial of Hysteroscopic Suture Fixation of Mirena in the Treatment of Adenomyosis
- ClinicalTrials.gov ID
- NCT06478992
- Acronym / sponsor ID
- IIT-20220610-0097-02
- Conditions
- Adenomyosis, Hysteroscopy
- Keywords
- Suture fixation, Expulsion, Mirena, Adenomyosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- First People's Hospital of HangzhouUniversity, hospital or other
- Study start
- 30 Jun 2024 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 27 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study was a multicenter, randomized (1:1 allocation to each group), double-blind, parallel controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the thickness of the thickest uterine myometrium ≥30mm | Other | Procedure: A:hysteroscopic suture fixation of Mirena, Procedure: A: simple Mirena placement under hysteroscopy |
| the thickness of the thickest uterine myometrium <30mm | Other | Procedure: B: hysteroscopic suture fixation of Mirena, Procedure: B：simple Mirena placement under hysteroscopy |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pain due to adenomyosis (lower abdominal pain and low back pain) visual analogue scale (VAS) ≥40mm or menstrual volume score (PBAC) ≥100;
Key exclusion criteria (6 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A:hysteroscopic suture fixation of MirenaA(the thickness of the thickest uterine myometrium ≥30mm ):The Mirena is fixed to the uterine wall under hysteroscopy, and the endometrial tissue was routinely aspirated and scraped during the operation and sent for pathological examination. | Procedure or surgery | the thickness of the thickest uterine myometrium ≥30mm |
| A: simple Mirena placement under hysteroscopyA(the thickness of the thickest uterine myometrium ≥30mm):Mirena is routinely placed in the uterine cavity under hysteroscopy, and endometrial tissue was routinely aspirated and scraped during the operation and sent for pathological examination. | Procedure or surgery | the thickness of the thickest uterine myometrium ≥30mm |
| B: hysteroscopic suture fixation of MirenaB(the thickness of the thickest uterine myometrium<30mm):The Mirena is fixed to the uterine wall under hysteroscopy, and the endometrial tissue was routinely aspirated and scraped during the operation and sent for pathological examination. | Procedure or surgery | the thickness of the thickest uterine myometrium <30mm |
| B：simple Mirena placement under hysteroscopyB(the thickness of the thickest uterine myometrium<30mm):Mirena is routinely placed in the uterine cavity under hysteroscopy, and endometrial tissue was routinely aspirated and scraped during the operation and sent for pathological examination. | Procedure or surgery | the thickness of the thickest uterine myometrium <30mm |
Primary outcome
expulsion rate of the Mirena
Time frame: 1, 3, 6, and 12 months postoperatively
3 secondary outcomes
menstrual volume
Time frame: 1, 3, 6, and 12 months postoperatively
dysmenorrhea
Time frame: 1, 3, 6, and 12 months postoperatively
uterine size under ultrasound
Time frame: 1, 3, 6, and 12 months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing A:hysteroscopic suture fixation of Mirena, A: simple Mirena placement under hysteroscopy and B: hysteroscopic suture fixation of Mirena in people with Adenomyosis and Hysteroscopy, run by First People's Hospital of Hangzhou.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
expulsion rate of the Mirena (time frame: 1, 3, 6, and 12 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2024.