- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06250569
Adenomyosis in Fertile Women in MUSA Criteria
February 1, 2024 updated by: Aya nour Elzanaty, Assiut University
Application of the Revised Morphological Uterus Sonographic Assessment (MUSA) Criteria to Diagnose Adenomyosis in Fertile Women
- To estimate the prevalence of adenomyosis in fertile women aged 18-30 years using the revised MUSA ultrasound criteria.
- To evaluate clinical risk factors that are associated with adenomyosis diagnosis in this population
Study Overview
Status
Not yet recruiting
Conditions
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.
Study Type
Observational
Enrollment (Estimated)
144
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Aya Nour elzanaty, MBBch
- Phone Number: 01022739886
- Email: Aya.elzanaty214@gmail.com
Study Contact Backup
- Name: Essam Rashad, Prof
- Phone Number: 01001330534
- Email: essamothman@aun.edu.eg
Study Locations
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Assiut, Egypt, 71515
- Assuit University
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Contact:
- Aya Nour Elzanaty
- Phone Number: 01022739886
- Email: Aya.elzanaty214@gmail.com
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
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 )
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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first group
women with with adenomyosis
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second group
women without adenomyosis
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
adenomyosis in fertile women
Time Frame: 1.5 year
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Estimation of the prevalence of adenomyosis diagnosed using revised MUSA criteria among fertile women aged 18-30 years.
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1.5 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: safwat abdelrady, Prof, Assiut University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
February 1, 2024
Primary Completion (Estimated)
June 1, 2025
Study Completion (Estimated)
July 1, 2025
Study Registration Dates
First Submitted
January 26, 2024
First Submitted That Met QC Criteria
February 1, 2024
First Posted (Actual)
February 9, 2024
Study Record Updates
Last Update Posted (Actual)
February 9, 2024
Last Update Submitted That Met QC Criteria
February 1, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Adenomyosis in fertile womens
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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