Adenomyosis in Fertile Women in MUSA Criteria

Adenomyosis Clinical Trial

Official title:

Application of the Revised Morphological Uterus Sonographic Assessment (MUSA) Criteria to Diagnose Adenomyosis in Fertile Women

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06250569
• Other study ID #: Adenomyosis in fertile womens
• Status: Not yet recruiting
• Start date: February 2024
• Est. completion date: July 2025

Study information

• Verified date: February 2024
• Source: Assiut University
• Contact: Aya Nour elzanaty, MBBch
• Phone: 01022739886
• Email: Aya.elzanaty214[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 144
• Est. completion date: July 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenomyosis

Locations

Country	Name	City	State
Egypt	Assuit university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View Citation

Karol D, Williamson M, Pereira N. Successful Expectant Management of a Tubal Ectopic Pregnancy. J Minim Invasive Gynecol. 2023 Nov 30:S1553-4650(23)00972-X. doi: 10.1016/j.jmig.2023.11.011. Online ahead of print. No abstract available. — View Citation

Marion LL, Meeks GR. Ectopic pregnancy: History, incidence, epidemiology, and risk factors. Clin Obstet Gynecol. 2012 Jun;55(2):376-86. doi: 10.1097/GRF.0b013e3182516d7b. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adenomyosis in fertile women	Estimation of the prevalence of adenomyosis diagnosed using revised MUSA criteria among fertile women aged 18-30 years.	1.5 year