New Pre-Surgical Scoring System for Uterine Septum

NCT ID: NCT05823103

Last Updated: 2023-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-18

Study Completion Date

2023-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Septate Uterus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hysteroscopic Metroplasty using ESHRE ASRM Classification

Group Type ACTIVE_COMPARATOR

ESHRE ASRM Classification

Intervention Type DIAGNOSTIC_TEST

Utilising the current classification before performing hysteroscopic metroplasty

Hysteroscopic Metroplasty using Shawki Septum Scoring System

Group Type ACTIVE_COMPARATOR

Shawki Septum Scoring System

Intervention Type DIAGNOSTIC_TEST

Utilising the novel scoring system to facilitate feasibility and safety of hysteroscopic metroplasty for uterine septum

Interventions

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Shawki Septum Scoring System

Utilising the novel scoring system to facilitate feasibility and safety of hysteroscopic metroplasty for uterine septum

Intervention Type DIAGNOSTIC_TEST

ESHRE ASRM Classification

Utilising the current classification before performing hysteroscopic metroplasty

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Uterine Septum diagnosed by 3D ultrasound

Exclusion Criteria

\-
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ebtesama Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yehia Shawki

Director of Endoscopy Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yehia Shawki, MRCOG

Role: PRINCIPAL_INVESTIGATOR

Endo-Planet

Locations

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Shifa Hospital

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Yehia Shawki, MRCOG

Role: CONTACT

00201001226662

Facility Contacts

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Yehia Shawki, MRCOG

Role: primary

00201001226662

References

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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, Goddijn M. The randomised uterine septum transsection trial (TRUST): design and protocol. BMC Womens Health. 2018 Oct 5;18(1):163. doi: 10.1186/s12905-018-0637-6.

Reference Type RESULT
PMID: 30290803 (View on PubMed)

Practice Committee of the American Society for Reproductive Medicine. Electronic address: [email protected]; Practice Committee of the American Society for Reproductive Medicine. Uterine septum: a guideline. Fertil Steril. 2016 Sep 1;106(3):530-40. doi: 10.1016/j.fertnstert.2016.05.014. Epub 2016 May 25.

Reference Type RESULT
PMID: 27235766 (View on PubMed)

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 Sonohysterography and Three-Dimensional Ultrasound in the Diagnosis of Septate Uterus-A Systematic Review and Meta-Analysis. Diagnostics (Basel). 2023 Feb 20;13(4):807. doi: 10.3390/diagnostics13040807.

Reference Type RESULT
PMID: 36832295 (View on PubMed)

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 uterus: an international multicentre open-label randomized controlled trial. Hum Reprod. 2021 Apr 20;36(5):1260-1267. doi: 10.1093/humrep/deab037.

Reference Type RESULT
PMID: 33793794 (View on PubMed)

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;8:52. doi: 10.1186/1477-7827-8-52.

Reference Type RESULT
PMID: 20492650 (View on PubMed)

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.

Reference Type RESULT
PMID: 12870384 (View on PubMed)

Other Identifiers

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100032023001

Identifier Type: -

Identifier Source: org_study_id

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