New Pre-Surgical Scoring System for Uterine Septum

Septate Uterus Clinical Trial

Official title:

Uterine Septum: Novel Pre-surgical Scoring System to Aid and Standardise Hysteroscopic Metroplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05823103
• Other study ID #: 100032023001
• Status: Recruiting
• Phase: N/A
• Start date: November 18, 2018
• Est. completion date: December 30, 2023

Study information

• Verified date: April 2023
• Source: Ebtesama Hospital
• Contact: Yehia Shawki, MRCOG
• Phone: 00201001226662
• Email: yehiaoshawki[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comparing surgical outcomes of Hysteroscopic metroplasty for uterine septum when using the standard ESGE or ASRM classifications vs the novel scoring system dubbed Shawki Septum Scoring System.

Outcomes based primarily on completion of the septal correction (no residual parts) and avoiding complications, the most significant of which are uterine perforation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• Uterine Septum diagnosed by 3D ultrasound

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Septate Uterus

Intervention

Diagnostic Test:
• Shawki Septum Scoring System
Utilising the novel scoring system to facilitate feasibility and safety of hysteroscopic metroplasty for uterine septum
• ESHRE ASRM Classification
Utilising the current classification before performing hysteroscopic metroplasty

Locations

Country	Name	City	State
Egypt	Shifa Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ebtesama Hospital

Country where clinical trial is conducted

Egypt, 

References & Publications (6)

Agostini A, Bretelle F, Cravello L, Ronda I, Roger V, Blanc B. [Complications of operative hysteroscopy]. Presse Med. 2003 May 24;32(18):826-9. French. — View Citation

Alcazar JL, Carriles I, Cajas MB, Costa S, Fabra S, Cabrero M, Castro E, Tomaizeh A, Laza MV, Monroy A, Martinez I, Aguilar MI, Hernani E, Castellet C, Oliva A, Pascual MA, Guerriero S. Diagnostic Performance of Two-Dimensional Ultrasound, Two-Dimensional — View Citation

Nouri K, Ott J, Huber JC, Fischer EM, Stogbauer L, Tempfer CB. Reproductive outcome after hysteroscopic septoplasty in patients with septate uterus--a retrospective cohort study and systematic review of the literature. Reprod Biol Endocrinol. 2010 May 21; — View Citation

Practice Committee of the American Society for Reproductive Medicine. Electronic address: ASRM@asrm.org; Practice Committee of the American Society for Reproductive Medicine. Uterine septum: a guideline. Fertil Steril. 2016 Sep 1;106(3):530-40. doi: 10.10 — View Citation

Rikken JFW, Kowalik CR, Emanuel MH, Bongers MY, Spinder T, de Kruif JH, Bloemenkamp KWM, Jansen FW, Veersema S, Mulders AGMGJ, Thurkow AL, Hald K, Mohazzab A, Khalaf Y, Clark TJ, Farrugia M, van Vliet HA, Stephenson MS, van der Veen F, van Wely M, Mol BWJ — View Citation

Rikken JFW, Kowalik CR, Emanuel MH, Bongers MY, Spinder T, Jansen FW, Mulders AGMGJ, Padmehr R, Clark TJ, van Vliet HA, Stephenson MD, van der Veen F, Mol BWJ, van Wely M, Goddijn M. Septum resection versus expectant management in women with a septate ute — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with Complete Septum Correction	No residual septum on 3D ultrasound	1 month
Primary	Percentage of patients who had an intra-operative Uterine perforation	Diminishing the risk of intra-operative perforation of the fundus	during the surgery