- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05901948
Pre-Surgical Grading System of Asherman Syndrome
June 4, 2023 updated by: Yehia Shawki, Ebtesama Hospital
Asherman Syndrome: Pre-surgical Grading to Improve Gauge Prognostic Values and Improve Outcomes
Utilising a novel pre-surgical grading system to class cases of asherman syndrome into 3 groups based on expected difficulty of surgery and potential prognostic outcomes.
Study Overview
Detailed Description
Using the grading system, patients are classified into Mild, Moderate and Severe Asherman Syndrome.
With the mild disease having the best prognostic value and a 1 step procedure, Moderate cases having a mediocre prognosis and usually multi-step procedure and Severe cases having a poor prognosis and counseled to other options.
This observational study looks at the surgical outcomes following hysteroscopy for cases graded according to the new system to identify the accuracy of the classification in predicting the surgical success and prognostic value.
Study Type
Observational
Enrollment (Actual)
65
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Cairo, Egypt, 11341
- Ebtesama Hospital
-
-
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
No
Sampling Method
Non-Probability Sample
Study Population
Patients complaining of hypomenorrhea, amenorrhea or infertility, who have a hysterosalpingography confirming intrauterine adhesions (Asherman Syndrome)
Description
Inclusion Criteria:
- Asherman Syndrome
- intra-uterine synechiae
Exclusion Criteria:
- patients with a fundectomy or uterine reduction surgery.
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 |
Intervention / Treatment |
---|---|
Asherman Patients
Patients diagnosed with Asherman syndrome based on patient complaint of hypomenorrhea or amenorrhea and hysterosalpingography.
|
Novel Asherman Scoring Classification
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage Resumption of normal cavity on hystero-salpingography
Time Frame: 1 month
|
assessing the improvement of the cavity of the uterus in hystero-salpingography
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Menses
Time Frame: 3 months
|
Improvement in patients menstrual cycle
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Osama Shawki, MD, Cairo 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
- Dreisler E, Kjer JJ. Asherman's syndrome: current perspectives on diagnosis and management. Int J Womens Health. 2019 Mar 20;11:191-198. doi: 10.2147/IJWH.S165474. eCollection 2019.
- Salazar CA, Isaacson K, Morris S. A comprehensive review of Asherman's syndrome: causes, symptoms and treatment options. Curr Opin Obstet Gynecol. 2017 Aug;29(4):249-256. doi: 10.1097/GCO.0000000000000378.
- Di Guardo F, Della Corte L, Vilos GA, Carugno J, Torok P, Giampaolino P, Manchanda R, Vitale SG. Evaluation and treatment of infertile women with Asherman syndrome: an updated review focusing on the role of hysteroscopy. Reprod Biomed Online. 2020 Jul;41(1):55-61. doi: 10.1016/j.rbmo.2020.03.021. Epub 2020 Apr 28.
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 (Actual)
January 7, 2020
Primary Completion (Actual)
January 31, 2023
Study Completion (Actual)
March 15, 2023
Study Registration Dates
First Submitted
June 4, 2023
First Submitted That Met QC Criteria
June 4, 2023
First Posted (Estimated)
June 13, 2023
Study Record Updates
Last Update Posted (Estimated)
June 13, 2023
Last Update Submitted That Met QC Criteria
June 4, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 100032023002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Sharing IPD in an effort to garner more research and interest in the field
IPD Sharing Time Frame
1 year after completion
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
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.
Clinical Trials on Asherman Syndrome
-
University of California, San FranciscoTerminatedInfertility | Asherman's SyndromeUnited States
-
The Second Affiliated Hospital of Chongqing Medical...Shanghai iCELL Biotechnology Co., Ltd, Shanghai, ChinaUnknownAsherman's Syndrome
-
Yuqing ChenCompleted
-
IgenomixUnknown
-
Women's Hospital School Of Medicine Zhejiang UniversityNot yet recruiting
-
Acibadem UniversityBaskent UniversityCompleted
-
Fu Xing Hospital, Capital Medical UniversityEnrolling by invitation
-
Wenzhou Medical UniversityCompleted
-
The Affiliated Nanjing Drum Tower Hospital of Nanjing...Changzhou Maternal and Child Care HospitalCompletedInfertility | Asherman SyndromeChina
-
Beijing Obstetrics and Gynecology HospitalUnknownIntrauterine AdhesionChina
Clinical Trials on Classification
-
Lyell McEwin HospitalUniversity of AdelaideCompletedColorectal Neoplasms | Colorectal Polyp
-
Columbia UniversityCenters for Disease Control and Prevention; Ministry of Health, RwandaCompleted
-
Piazza della Vittoria 14 Studio Medico - Ginecologia...RecruitingEndometriosis | Deep Endometriosis | Ovarian Endometrioma | Bowel EndometriosisItaly
-
Peking University Third HospitalCompletedMRI | Tennis Elbow | HyperlipidemiaChina
-
Vascular surgery, University hospital Královské...Belfast Health and Social Care TrustActive, not recruitingArteriovenous Fistula | Kidney Failure | Arteriovenous Graft | Dialysis Access Malfunction | Dialysis Related ComplicationCzechia
-
Hannover Medical SchoolRecruitingComplication of Surgical ProcedureGermany
-
Göteborg UniversityActive, not recruitingPregnancy, High Risk | Pregnancy, Ectopic | Pregnancy EarlySweden
-
Universita di VeronaCompletedPerineal Tear | Delivery; Injury, Maternal | Episiotomy WoundItaly
-
Selcuk UniversityCompleted
-
Kutahya Health Sciences UniversityCompleted