AdenomyosisNCT03120078
A Prospective Study of Diagnostic Accuracy of Ultrasound
An observational study of Adenomyosis, run by Texas Tech University Health Sciences Center, El Paso at 1 site in United States.
Trial summary
Prospectively-Patients undergoing a hysterectomy for abnormal uterine bleeding (AUB) or pelvic pain will be enrolled in the study, will get pelvic ultrasound at the ultrasound clinic. An ultrasound will be obtained as part of the required clinical assessment before the patient undergoes a hysterectomy. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Adenomyosis
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2017to 14 Dec 2017
- 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 60 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Patients undergoing hysterectomy for with AUB or pelvic pain will be enrolled in the study.
Who may be able to join
- Women
- 18 years or older but 60 years or less.
- Undergoing hysterectomy for AUB or pelvic pain
Who cannot join
- known cause of AUB or pelvic pain
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Tech University Health Science Center
El Paso, Texas, 79905
About this study
Official title: Diagnostic Accuracy of Ultrasound for Adenomyosis, Development of Scoring System and Correlation With Various Pelvic Pathologies: a Prospective Study.
Prospectively-Patients undergoing a hysterectomy for abnormal uterine bleeding (AUB) or pelvic pain will be enrolled in the study, will get pelvic ultrasound at the ultrasound clinic. An ultrasound will be obtained as part of the required clinical assessment before the patient undergoes a hysterectomy. The ultrasound images will be reviewed using Viewpoint reporting system-various sonographic features of adenomyosis will be reported detailed, including pelvic pathology, pelvic congestion syndrome etc. The histopathological examination will be done by assigned pathologist for accurate mapping/localizing the adenomyosis (appropriate section of uterus to defining localized versus generalized adenomyosis) on all patients diagnosed with adenomyosis on ultrasound. The ultrasound will be correlated with histopathology(which is the gold standard for diagnosis of adenomyosis). Scoring system for adenomyosis based on various sonographic features/clinical symptoms and their confirmation with histopathology will be developed.
Read the detailed description
The association between adenomyosis, assisted reproductive technology (ART) outcomes and pregnancy complications is well established.
Adenomyosis uteri is a common gynecologic disorder with unclear etiology, characterized by the presence of hetero- topic endometrial glands and stroma in the myometrium with adjacent smooth muscle hyperplasia, defined histopathologically. Uterine adenomyosis is relatively frequent, and the diagnosis is more often made in multiparous patients in their fourth and fifth decade of life. It has been noted in 20% to 30% of the general female population and in up to 70% of hysterectomy specimens, depending on the definition used.
Accurate diagnosis and localization of the disease is important, in particular when fertility conservation is warranted. Management options include medical therapy and surgery. Medical therapies target symptomatic relief and include oral contraceptive agents, progestin therapy including the levonorgestrel-releasing intrauterine system, danazol, gonadotropin-releasing hormone agonists, and aromatase inhibitors. More uterine sparing surgical options are investigated for treatment of adenomyoisis. Surgical management can be divided into uterine sparing options such as hysteroscopic or laparoscopic resection of focal disease, endometrial ablation, uterine artery embolization, and MRgFUS, or definitive treatment via hysterectomy. The sensitivity and specificity of MRI in diagnosing adenomyosis range from 88% to 93% and 67% to 91%, respectively. Ultrasound has limitation especially when myomas are associated with adenomyosis in 36% to 50% of cases, making MRI an ideal imaging method in that scenario. The sensitivity of ultrasound to detect adenomyosis ranges from 65% to 81%, and specificity ranges from 65% to 100%. A recent meta-analysis on the accuracy of ultrasound in the diagnosis of adenomyosis demonstrated sensitivity of 82.5% (95% confidence interval, 77.5-87.9) and specificity of 84.6% (95% confidence interval, 79.8-89.8), with a positive likelihood ratio of 4.7 (3.1-7.0) and negative likelihood ratio of 0.26 (0.18-0.39), comparable to MRI.
Adenomyosis is a heterogeneous entity and thus its sonographic appearance is also variable. The variation in the degree of invasion and the heterogeneity in the reaction of surrounding tissue account for the ultrasound findings of adenomyosis. It manifests most commonly as a diffuse disease involving the entire myometrium and commonly involves the posterior uterine wall. It can also present as a localized focal entity known as nodular adenomyosis or an adenomyomas.
Following are common sonographic features of adenomyoisis.
- Heterogeneous Myometrium: Lack of homogeneity within the myometrium, with evidence of architectural disturbance with increased and decreased echoes. This is most predictive of adenomyosis.
- Loss of endometrium-myometrium border: Invasion of the myometrium by the glands also obscures the normally distinct endometrium-myometrium border, making it difficult to measure. This is a layer that appears as a hypoechoic halo surrounding the endometrial layer. In the past this was obtainable only with MRI; however, with newer high-resolution ultrasound, in particular using 3D rendering, it is now possible to visualize this layer. Thickness >8 to 12 mm is associated with adenomyosis.
- Echogenic linear striations: Invasion of the endometrial glands into the subendometrial tissue induces a hyperplastic reaction that appears as echogenic linear striations fanning out from the endometrial layer.
- Asymmetrical Uterine wall thickening: anteroposterior asymmetry, in particular when the disease is focal.
- Color Doppler ultrasonography can also be used to differentiate adenomyosis from leiomyomas. Random scattering of vessels or intramural signals in adenomyosis cases. In contrast, in leiomyoma cases the vessels were peripheral or outer feeding vessels.
The investigators are trying to see what are the most common sonographic features of adenomyosis.
There is no clear terminology and consensus on classification of adenomyoisis on ultrasound images. Since this is a heterogeneous condition, significantly affects reproduction and newer specific uterine sparing options warrants correct localization and subclassify the disease burden like overt adenomyoisis versus localized adenomyomas. Also recently there is evidence that adenomyoisis is a progressive disease.
Presented data will aid in development of the integrated scoring system for detection and objective assessment of adenomyosis.
- Conditions
- Adenomyosis
- Keywords
- Ultrasound
- Medical subject headings
- Adenomyosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Develop a scoring system for adenomyosis based on various sonographic features and clinical symptoms.
Sonographic features
Measured: Duration of Study
Secondary outcomes (3)
Review the diagnostic accuracy of ultrasound with adenomyosis.
Various sonographic features of adenomyosis will be reported
Measured: Duration of study
Prevalence of coexisting pathology.
Correlation with histopathology.
Measured: Duration of Study
Menstrual bleeding questionnaire
Comprehensive patient reported outcome instrument for heavy menstrual bleeding.
Measured: Duration of Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study start1 Jun 2017
- Primary completion14 Dec 2017
- Study completion14 Dec 2017
Why it stopped: The PI has requested to close this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for AdenomyosisStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center, El Paso
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sushila Arya, Texas Tech University Health Sciences Center, El Paso
- Investigators
- Sushila Arya, MD, Principal investigator, Texas Tech University Health Sciences Center, El Paso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03120078
- Sponsor's protocol ID
- E17057
- Status last verified
- Apr 2018
- First submitted
- 13 Apr 2017
- Last updated
- 26 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: RedCap
Publications
Devlieger R, D'Hooghe T, Timmerman D. Uterine adenomyosis in the infertility clinic. Hum Reprod Update. 2003 Mar-Apr;9(2):139-47. doi: 10.1093/humupd/dmg010.
PubMed 12751776Azziz R. Adenomyosis: current perspectives. Obstet Gynecol Clin North Am. 1989 Mar;16(1):221-35.
PubMed 2664619Vercellini P, Ragni G, Trespidi L, Oldani S, Panazza S, Crosignani PG. Adenomyosis: a deja vu? Obstet Gynecol Surv. 1993 Dec;48(12):789-94.
PubMed 8309661Farquhar C, Brosens I. Medical and surgical management of adenomyosis. Best Pract Res Clin Obstet Gynaecol. 2006 Aug;20(4):603-16. doi: 10.1016/j.bpobgyn.2006.01.012. Epub 2006 Mar 24.
PubMed 16563872Bragheto AM, Caserta N, Bahamondes L, Petta CA. Effectiveness of the levonorgestrel-releasing intrauterine system in the treatment of adenomyosis diagnosed and monitored by magnetic resonance imaging. Contraception. 2007 Sep;76(3):195-9. doi: 10.1016/j.contraception.2007.05.091. Epub 2007 Jul 27.
PubMed 17707716Garcia L, Isaacson K. Adenomyosis: review of the literature. J Minim Invasive Gynecol. 2011 Jul-Aug;18(4):428-37. doi: 10.1016/j.jmig.2011.04.004. Epub 2011 May 31.
PubMed 21622029Dong X, Yang Z. High-intensity focused ultrasound ablation of uterine localized adenomyosis. Curr Opin Obstet Gynecol. 2010 Aug;22(4):326-30. doi: 10.1097/GCO.0b013e32833bea2e.
PubMed 20610999Horng HC, Chen CH, Chen CY, Tsui KH, Liu WM, Wang PH, Chang WH, Huang BS, Sun HD, Chang TC, Chang WC, Yen MS. Uterine-sparing surgery for adenomyosis and/or adenomyoma. Taiwan J Obstet Gynecol. 2014 Mar;53(1):3-7. doi: 10.1016/j.tjog.2014.01.001.
PubMed 24767637Fukunishi H, Funaki K, Sawada K, Yamaguchi K, Maeda T, Kaji Y. Early results of magnetic resonance-guided focused ultrasound surgery of adenomyosis: analysis of 20 cases. J Minim Invasive Gynecol. 2008 Sep-Oct;15(5):571-9. doi: 10.1016/j.jmig.2008.06.010. Epub 2008 Jul 26.
PubMed 18657480Kim MD, Kim S, Kim NK, Lee MH, Ahn EH, Kim HJ, Cho JH, Cha SH. Long-term results of uterine artery embolization for symptomatic adenomyosis. AJR Am J Roentgenol. 2007 Jan;188(1):176-81. doi: 10.2214/AJR.05.1613.
PubMed 17179361Kitamura Y, Allison SJ, Jha RC, Spies JB, Flick PA, Ascher SM. MRI of adenomyosis: changes with uterine artery embolization. AJR Am J Roentgenol. 2006 Mar;186(3):855-64. doi: 10.2214/AJR.04.1661.
PubMed 16498121Pelage JP, Jacob D, Fazel A, Namur J, Laurent A, Rymer R, Le Dref O. Midterm results of uterine artery embolization for symptomatic adenomyosis: initial experience. Radiology. 2005 Mar;234(3):948-53. doi: 10.1148/radiol.2343031697. Epub 2005 Jan 28.
PubMed 15681687Wang PH, Liu WM, Fuh JL, Cheng MH, Chao HT. Comparison of surgery alone and combined surgical-medical treatment in the management of symptomatic uterine adenomyoma. Fertil Steril. 2009 Sep;92(3):876-885. doi: 10.1016/j.fertnstert.2008.07.1744. Epub 2008 Sep 6.
PubMed 18774566Wood C. Surgical and medical treatment of adenomyosis. Hum Reprod Update. 1998 Jul-Aug;4(4):323-36. doi: 10.1093/humupd/4.4.323.
PubMed 9825848Bazot M, Cortez A, Darai E, Rouger J, Chopier J, Antoine JM, Uzan S. Ultrasonography compared with magnetic resonance imaging for the diagnosis of adenomyosis: correlation with histopathology. Hum Reprod. 2001 Nov;16(11):2427-33. doi: 10.1093/humrep/16.11.2427.
PubMed 11679533
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Ultrasound for Adenomyosis, Development of Scoring System and Correlation With Various Pelvic Pathologies: a Prospective Study.
- ClinicalTrials.gov ID
- NCT03120078
- Acronym / sponsor ID
- E17057
- Conditions
- Adenomyosis
- Keywords
- Ultrasound
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The PI has requested to close this study.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences Center, El PasoUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 14 Dec 2017 (actual)
- Study completion
- 14 Dec 2017 (actual)
- First posted
- 19 Apr 2017 (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.
Prospectively-Patients undergoing a hysterectomy for abnormal uterine bleeding (AUB) or pelvic pain will be enrolled in the study, will get pelvic ultrasound at the ultrasound clinic. An ultrasound will be obtained as part of the required clinical assessment before the patient undergoes a hysterectomy. The ultrasound images will be reviewed using Viewpoint reporting system-various sonographic features of adenomyosis will be reported detailed, including pelvic pathology, pelvic congestion syndrome etc. The histopathological examination will be done by assigned pathologist for accurate mapping/localizing the adenomyosis (appropriate section of uterus to defining localized versus generalized adenomyosis) on all patients diagnosed with adenomyosis on ultrasound. The ultrasound will be correlated with histopathology(which is the gold standard for diagnosis of adenomyosis). Scoring system for adenomyosis based on various sonographic features/clinical symptoms and their confirmation with histopathology will be developed.
Detailed description
The association between adenomyosis, assisted reproductive technology (ART) outcomes and pregnancy complications is well established.
Adenomyosis uteri is a common gynecologic disorder with unclear etiology, characterized by the presence of hetero- topic endometrial glands and stroma in the myometrium with adjacent smooth muscle hyperplasia, defined histopathologically. Uterine adenomyosis is relatively frequent, and the diagnosis is more often made in multiparous patients in their fourth and fifth decade of life. It has been noted in 20% to 30% of the general female population and in up to 70% of hysterectomy specimens, depending on the definition used.
Accurate diagnosis and localization of the disease is important, in particular when fertility conservation is warranted. Management options include medical therapy and surgery. Medical therapies target symptomatic relief and include oral contraceptive agents, progestin therapy including the levonorgestrel-releasing intrauterine system, danazol, gonadotropin-releasing hormone agonists, and aromatase inhibitors. More uterine sparing surgical options are investigated for treatment of adenomyoisis. Surgical management can be divided into uterine sparing options such as hysteroscopic or laparoscopic resection of focal disease, endometrial ablation, uterine artery embolization, and MRgFUS, or definitive treatment via hysterectomy. The sensitivity and specificity of MRI in diagnosing adenomyosis range from 88% to 93% and 67% to 91%, respectively. Ultrasound has limitation especially when myomas are associated with adenomyosis in 36% to 50% of cases, making MRI an ideal imaging method in that scenario. The sensitivity of ultrasound to detect adenomyosis ranges from 65% to 81%, and specificity ranges from 65% to 100%. A recent meta-analysis on the accuracy of ultrasound in the diagnosis of adenomyosis demonstrated sensitivity of 82.5% (95% confidence interval, 77.5-87.9) and specificity of 84.6% (95% confidence interval, 79.8-89.8), with a positive likelihood ratio of 4.7 (3.1-7.0) and negative likelihood ratio of 0.26 (0.18-0.39), comparable to MRI.
Adenomyosis is a heterogeneous entity and thus its sonographic appearance is also variable. The variation in the degree of invasion and the heterogeneity in the reaction of surrounding tissue account for the ultrasound findings of adenomyosis. It manifests most commonly as a diffuse disease involving the entire myometrium and commonly involves the posterior uterine wall. It can also present as a localized focal entity known as nodular adenomyosis or an adenomyomas.
Following are common sonographic features of adenomyoisis.
- Heterogeneous Myometrium: Lack of homogeneity within the myometrium, with evidence of architectural disturbance with increased and decreased echoes. This is most predictive of adenomyosis.
- Loss of endometrium-myometrium border: Invasion of the myometrium by the glands also obscures the normally distinct endometrium-myometrium border, making it difficult to measure. This is a layer that appears as a hypoechoic halo surrounding the endometrial layer. In the past this was obtainable only with MRI; however, with newer high-resolution ultrasound, in particular using 3D rendering, it is now possible to visualize this layer. Thickness >8 to 12 mm is associated with adenomyosis.
- Echogenic linear striations: Invasion of the endometrial glands into the subendometrial tissue induces a hyperplastic reaction that appears as echogenic linear striations fanning out from the endometrial layer.
- Asymmetrical Uterine wall thickening: anteroposterior asymmetry, in particular when the disease is focal.
- Color Doppler ultrasonography can also be used to differentiate adenomyosis from leiomyomas. Random scattering of vessels or intramural signals in adenomyosis cases. In contrast, in leiomyoma cases the vessels were peripheral or outer feeding vessels.
The investigators are trying to see what are the most common sonographic features of adenomyosis.
There is no clear terminology and consensus on classification of adenomyoisis on ultrasound images. Since this is a heterogeneous condition, significantly affects reproduction and newer specific uterine sparing options warrants correct localization and subclassify the disease burden like overt adenomyoisis versus localized adenomyomas. Also recently there is evidence that adenomyoisis is a progressive disease.
Presented data will aid in development of the integrated scoring system for detection and objective assessment of adenomyosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients undergoing hysterectomy for with AUB or pelvic pain will be enrolled in the study.
Key inclusion criteria (3 listed)
- Women
- 18 years or older but 60 years or less.
- Undergoing hysterectomy for AUB or pelvic pain
Key exclusion criteria (1 listed)
- known cause of AUB or pelvic pain
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
Develop a scoring system for adenomyosis based on various sonographic features and clinical symptoms.
Time frame: Duration of Study
Sonographic features
3 secondary outcomes
Review the diagnostic accuracy of ultrasound with adenomyosis.
Time frame: Duration of study
Prevalence of coexisting pathology.
Time frame: Duration of Study
Menstrual bleeding questionnaire
Time frame: Duration of Study
Results and safety
The study was stopped early (reason given: The PI has requested to close this study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2018.
- Background: PubMed 12751776Devlieger R, D'Hooghe T, Timmerman D. Uterine adenomyosis in the infertility clinic. Hum Reprod Update. 2003 Mar-Apr;9(2):139-47. doi: 10.1093/humupd/dmg010.
- Background: PubMed 2664619Azziz R. Adenomyosis: current perspectives. Obstet Gynecol Clin North Am. 1989 Mar;16(1):221-35.
- Background: PubMed 8309661Vercellini P, Ragni G, Trespidi L, Oldani S, Panazza S, Crosignani PG. Adenomyosis: a deja vu? Obstet Gynecol Surv. 1993 Dec;48(12):789-94.
- Background: PubMed 16563872Farquhar C, Brosens I. Medical and surgical management of adenomyosis. Best Pract Res Clin Obstet Gynaecol. 2006 Aug;20(4):603-16. doi: 10.1016/j.bpobgyn.2006.01.012. Epub 2006 Mar 24.
- Background: PubMed 17707716Bragheto AM, Caserta N, Bahamondes L, Petta CA. Effectiveness of the levonorgestrel-releasing intrauterine system in the treatment of adenomyosis diagnosed and monitored by magnetic resonance imaging. Contraception. 2007 Sep;76(3):195-9. doi: 10.1016/j.contraception.2007.05.091. Epub 2007 Jul 27.
- Background: PubMed 21622029Garcia L, Isaacson K. Adenomyosis: review of the literature. J Minim Invasive Gynecol. 2011 Jul-Aug;18(4):428-37. doi: 10.1016/j.jmig.2011.04.004. Epub 2011 May 31.
- Background: PubMed 20610999Dong X, Yang Z. High-intensity focused ultrasound ablation of uterine localized adenomyosis. Curr Opin Obstet Gynecol. 2010 Aug;22(4):326-30. doi: 10.1097/GCO.0b013e32833bea2e.
- Background: PubMed 24767637Horng HC, Chen CH, Chen CY, Tsui KH, Liu WM, Wang PH, Chang WH, Huang BS, Sun HD, Chang TC, Chang WC, Yen MS. Uterine-sparing surgery for adenomyosis and/or adenomyoma. Taiwan J Obstet Gynecol. 2014 Mar;53(1):3-7. doi: 10.1016/j.tjog.2014.01.001.
- Background: PubMed 18657480Fukunishi H, Funaki K, Sawada K, Yamaguchi K, Maeda T, Kaji Y. Early results of magnetic resonance-guided focused ultrasound surgery of adenomyosis: analysis of 20 cases. J Minim Invasive Gynecol. 2008 Sep-Oct;15(5):571-9. doi: 10.1016/j.jmig.2008.06.010. Epub 2008 Jul 26.
- Background: PubMed 17179361Kim MD, Kim S, Kim NK, Lee MH, Ahn EH, Kim HJ, Cho JH, Cha SH. Long-term results of uterine artery embolization for symptomatic adenomyosis. AJR Am J Roentgenol. 2007 Jan;188(1):176-81. doi: 10.2214/AJR.05.1613.
- Background: PubMed 16498121Kitamura Y, Allison SJ, Jha RC, Spies JB, Flick PA, Ascher SM. MRI of adenomyosis: changes with uterine artery embolization. AJR Am J Roentgenol. 2006 Mar;186(3):855-64. doi: 10.2214/AJR.04.1661.
- Background: PubMed 15681687Pelage JP, Jacob D, Fazel A, Namur J, Laurent A, Rymer R, Le Dref O. Midterm results of uterine artery embolization for symptomatic adenomyosis: initial experience. Radiology. 2005 Mar;234(3):948-53. doi: 10.1148/radiol.2343031697. Epub 2005 Jan 28.
- Individual participant dataSharing planned: No. RedCap
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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.
Sushila Arya, MD principal investigator
Texas Tech University Health Sciences Center, El Paso
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 Texas Tech University Health Sciences Center, El Paso at 1 site in United States.
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 3 inclusion and 1 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: stopped early, as of the sponsor's last update on 26 Apr 2018. 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 United States. 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?
The study was stopped early (reason given: The PI has requested to close this study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Develop a scoring system for adenomyosis based on various sonographic features and clinical symptoms. (time frame: Duration of Study). 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 NCT03120078, which also lists 20 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 26 Apr 2018.