Clinical trial NCT06250569: Adenomyosis in Fertile Women in MUSA Criteria
Official title: Application of the Revised Morphological Uterus Sonographic Assessment (MUSA) Criteria to Diagnose Adenomyosis in Fertile Women
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Adenomyosis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-02-09
Enrollment: 144
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study will include women with regular menstrual cycle attending outpatient clinic for contraception counseling( age 18 -30 years old ; written consent will be obtained )

Brief summary: 1. To estimate the prevalence of adenomyosis in fertile women aged 18-30 years using the revised MUSA ultrasound criteria.
2. To evaluate clinical risk factors that are associated with adenomyosis diagnosis in this population

Detailed description: Adenomyosis is a benign condition characterized by the presence endometrial glands and stroma within the myometrium. Its prevalence varies from 5-70%. The definitive diagnosis of adenomyosis is based mainly on histological assessment of hysterectomy specimens. This led to a concept that adenomyosis affects only parous women between 35-50 years who complain of dysmenorrhea and heavy menstrual bleeding. Magnetic Resonance Imaging (MRI) can detect adenomyosis with a sensitivity of 80%. Transvaginal ultrasound using the revised Morphological Uterus Sonographic Assessment (MUSA) criteria can detect adenomyosis non-invasively at a lower cost. Such advancements in imaging techniques allow studying the prevalence of the disease in wider range of population including young women.

Eligibility criteria: Inclusion Criteria:

* women with regular menstrual cycle attending outpatient clinic for contraception counseling
* age 18 -30 years old

Exclusion Criteria:

* Women on hormonal contraception
* Infertile women
* Associated pathologies like endometriosis, uterine fibroids. and ovarian cysts

Primary outcomes:
measure: adenomyosis in fertile women
timeFrame: 1.5 year
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assuit university
Study officials:
affiliation: Assiut University
name: safwat abdelrady, Prof
role: STUDY_DIRECTOR
References:
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citation: Practice Committee of American Society for Reproductive Medicine. Medical treatment of ectopic pregnancy. Fertil Steril. 2008 Nov;90(5 Suppl):S206-12. doi: 10.1016/j.fertnstert.2008.08.049.
citation: Karol D, Williamson M, Pereira N. Successful Expectant Management of a Tubal Ectopic Pregnancy. J Minim Invasive Gynecol. 2024 Feb;31(2):92-94. doi: 10.1016/j.jmig.2023.11.011. Epub 2023 Nov 30. No abstract available.
citation: Harmsen MJ, Van den Bosch T, de Leeuw RA, Dueholm M, Exacoustos C, Valentin L, Hehenkamp WJK, Groenman F, De Bruyn C, Rasmussen C, Lazzeri L, Jokubkiene L, Jurkovic D, Naftalin J, Tellum T, Bourne T, Timmerman D, Huirne JAF. Consensus on revised definitions of Morphological Uterus Sonographic Assessment (MUSA) features of adenomyosis: results of modified Delphi procedure. Ultrasound Obstet Gynecol. 2022 Jul;60(1):118-131. doi: 10.1002/uog.24786.