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A Prospective Multicenter Study regarding the Efficacy and Safety ofAdenomyomectomy

A Prospective Multicenter Study regarding the Efficacy and Safety ofAdenomyomectomy for the Patients with Adenomyosis Who Wish to Preserve Fertility

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1030240061
Enrollment
54
Registered
2024-05-07
Start date
2024-05-07
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenomyosis

Interventions

Perform adenomyomectomy

Sponsors

Hirota Yasushi
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1) Those who have received a diagnosis of uterine adenomyosis through MRI testing. 2) Those who wish to preserve their fertility. 3) Those who are 18 years of age or older at the time of obtaining consent. 4) Those who are pre-menopausal and still experience regular menstrual cycles. 5) Those for whom existing drug therapy for uterine adenomyosis cannot be conducted or has not resulted in significant symptom improvement. 6) Those with a combined Menstrual Difficulty Score of 3 or higher. 7) Those who are suitable candidates for surgical removal of uterine adenomyosis lesions. 8) Those who have received adequate explanation about participation in this study, have a thorough understanding, and have provided written consent of their own free will.

Exclusion criteria

Exclusion criteria: 1) Those with Grade 3 or higher complications according to CTCAE v5.0. 2) Those with unexplained abnormal genital bleeding. 3) Those with indicated uterine malignancies requiring treatment. 4) Those who are pregnant or may be pregnant. 5) Those deemed unsuitable for participation in this study by the Principal Investigator or Co-Investigator.

Design outcomes

Primary

MeasureTime frame
Change in the total score of dysmenorrhea after 3 months

Secondary

MeasureTime frame
1) Change in pain score on the dysmenorrhea score at 3 and 9 months. 2) Change in pain medication usage score on the dysmenorrhea score at 3 and 9 months. 3) Complete disappearance rate of the dysmenorrhea score at 3 and 9 months. 4) Change in the total score of the dysmenorrhea score at 9 months. 5) Change in uterine volume on MRI. 6) Change in pain (NRS 0-10) at 3 and 9 months due to dysmenorrhea. 7) Change in pelvic pain (NRS 0-10) at 3 and 9 months due to adenomyosis. 8) Change in non-menstrual pelvic pain (NRS 0-10) at 3 and 9 months. 9) Change in MMAS at 3 and 9 months. 10) Surgical outcomes in adenomyomectomy (surgical time, blood loss, surgical complications, extent of adenomyosis lesion excision, and specimen weight).

Contacts

Public ContactMitsunori Matsuo

The University of Tokyo Hospital

matsuom-gyn@h.u-tokyo.ac.jp+81-3-3815-5411

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026