AdenomyosisNCT06250569
Adenomyosis in Fertile Women in MUSA Criteria
An observational study of Adenomyosis, run by Assiut University at 1 site in Egypt.
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 Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Adenomyosis
- How many people
- 144 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2024to Jul 2025
- Phase
- Observational
- 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 30 years
- Women only
- Healthy volunteers accepted
- Adult
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 )
Who may be able to join
- women with regular menstrual cycle attending outpatient clinic for contraception counseling
- age 18 -30 years old
Who cannot join
- Women on hormonal contraception
- Infertile women
- Associated pathologies like endometriosis, uterine fibroids. and ovarian cysts
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Assuit university
Asyut, 71515
Aya Nour Elzanaty, 01022739886, Aya.elzanaty214@gmail.com
About this study
Official title: 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
Read the 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.
- Conditions
- Adenomyosis
- Medical subject headings
- Adenomyosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| first group | women with with adenomyosis | |
| second group | women without adenomyosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
adenomyosis in fertile women
Estimation of the prevalence of adenomyosis diagnosed using revised MUSA criteria among fertile women aged 18-30 years.
Measured: 1.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study startFeb 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AdenomyosisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya nour Elzanaty, Assiut University
- Investigators
- safwat abdelrady, Prof, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06250569
- Sponsor's protocol ID
- Adenomyosis in fertile womens
- Status last verified
- Feb 2024
- First submitted
- 26 Jan 2024
- Last updated
- 9 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22510618Practice 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.
PubMed 19007632Karol 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.
PubMed 38042476Harmsen 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.
PubMed 34587658
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of the Revised Morphological Uterus Sonographic Assessment (MUSA) Criteria to Diagnose Adenomyosis in Fertile Women
- ClinicalTrials.gov ID
- NCT06250569
- Acronym / sponsor ID
- Adenomyosis in fertile womens
- Conditions
- Adenomyosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Feb 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 9 Feb 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.
- 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
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| first group | – | –women with with adenomyosis |
| second group | – | –women without adenomyosis |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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 )
Key inclusion criteria (2 listed)
- women with regular menstrual cycle attending outpatient clinic for contraception counseling
- age 18 -30 years old
Key exclusion criteria (3 listed)
- Women on hormonal contraception
- Infertile women
- Associated pathologies like endometriosis, uterine fibroids. and ovarian cysts
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
adenomyosis in fertile women
Time frame: 1.5 year
Estimation of the prevalence of adenomyosis diagnosed using revised MUSA criteria among fertile women aged 18-30 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Background: PubMed 22510618Marion 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.
- Background: PubMed 19007632Practice 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.
- Background: PubMed 38042476Karol 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.
- Background: PubMed 34587658Harmsen 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.
- Individual participant dataSharing planned: No
Related trials for Adenomyosis
Not yet recruiting
Psychotherapy in Patients With Endometriosis: Cognitive Behavioral Therapy Versus Acceptance and Commitment Therapy
Endometriosis, Adenomyosis
Not yet recruiting
Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
Adenomyosis, Adenomyoma of Uterus
Not yet recruitingObservational study
Linzagolix in Adenomyosis and Recurrent Implantation Failure
Adenomyosis of Uterus, Implantation Failure
RecruitingObservational study
Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms
Adenomyosis of Uterus
Recruiting
Stellate Ganglion Block and Dexmedetomidine for Postoperative Sleep in Women Undergoing Laparoscopic Gynecologic Surgery
Uterine Fibroids (Leiomyoma), Adenomyosis of Uterus
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.
safwat abdelrady, Prof study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adenomyosis, run by Assiut University at 1 site in Egypt.
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 2 inclusion and 3 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 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Aya Nour elzanaty, MBBch (01022739886, Aya.elzanaty214@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adenomyosis in fertile women (time frame: 1.5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06250569, which also lists 4 linked publications.
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 9 Feb 2024.