Pre-Surgical Grading System of Asherman Syndrome

Asherman Syndrome Clinical Trial

Official title:

Asherman Syndrome: Pre-surgical Grading to Improve Gauge Prognostic Values and Improve Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05901948
• Other study ID #: 100032023002
• Status: Completed
• Start date: January 7, 2020
• Est. completion date: March 15, 2023

Study information

• Verified date: June 2023
• Source: Ebtesama Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: March 15, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• Asherman Syndrome
• intra-uterine synechiae

Exclusion Criteria:

• patients with a fundectomy or uterine reduction surgery.

Related Conditions & MeSH terms

• Asherman Syndrome
• Syndrome

Intervention

Other:
• Classification
Novel Asherman Scoring Classification

Locations

Country	Name	City	State
Egypt	Ebtesama Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ebtesama Hospital

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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( — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage Resumption of normal cavity on hystero-salpingography	assessing the improvement of the cavity of the uterus in hystero-salpingography	1 month
Secondary	Menses	Improvement in patients menstrual cycle	3 months