Septate UterusNCT05823103
New Pre-Surgical Scoring System for Uterine Septum
A study testing Shawki Septum Scoring System and ESHRE ASRM Classification in people with Septate Uterus, run by Ebtesama Hospital at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Septate Uterus
- What is being tested?
- Shawki Septum Scoring System and ESHRE ASRM Classification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Nov 2018to 30 Dec 2023
- Phase
- Interventional
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Uterine Septum diagnosed by 3D ultrasound
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Shifa Hospital
Cairo, 11835
Yehia Shawki, MRCOG, 00201001226662, yehiaoshawki@gmail.com
About this study
Official title: Uterine Septum: Novel Pre-surgical Scoring System to Aid and Standardise Hysteroscopic Metroplasty
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.
- Conditions
- Septate Uterus
- Being tested
- Shawki Septum Scoring System, ESHRE ASRM Classification
- Keywords
- Hysterscopy, Congenital Uterine Anomaly, Uterine Septum, Septet Uterus, Novel Scoring System, Shawki Septum Scoring System
- Medical subject headings
- Septate Uterus, Uterine Anomalies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shawki Septum Scoring SystemDiagnostic test
Utilising the novel scoring system to facilitate feasibility and safety of hysteroscopic metroplasty for uterine septum
ESHRE ASRM ClassificationDiagnostic test
Utilising the current classification before performing hysteroscopic metroplasty
| Study group | Role | What they receive |
|---|---|---|
| Hysteroscopic Metroplasty using ESHRE ASRM Classification | Active comparator | Not described Receives: Diagnostic Test: ESHRE ASRM Classification |
| Hysteroscopic Metroplasty using Shawki Septum Scoring System | Active comparator | Not described Receives: Diagnostic Test: Shawki Septum Scoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with Complete Septum Correction
No residual septum on 3D ultrasound
Measured: 1 month
Percentage of patients who had an intra-operative Uterine perforation
Diminishing the risk of intra-operative perforation of the fundus
Measured: during the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start18 Nov 2018
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Septate UterusStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ebtesama Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yehia Shawki, Ebtesama Hospital
- Investigators
- Yehia Shawki, MRCOG, Principal investigator, Endo-Planet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05823103
- Sponsor's protocol ID
- 100032023001
- Status last verified
- Apr 2023
- First submitted
- 27 Mar 2023
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 30290803Practice 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: 10.1016/j.fertnstert.2016.05.014. Epub 2016 May 25.
PubMed 27235766Alcazar 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.
PubMed 36832295Rikken 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.
PubMed 33793794Nouri 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.
PubMed 20492650Agostini 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.
PubMed 12870384
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uterine Septum: Novel Pre-surgical Scoring System to Aid and Standardise Hysteroscopic Metroplasty
- ClinicalTrials.gov ID
- NCT05823103
- Acronym / sponsor ID
- 100032023001
- Conditions
- Septate Uterus
- Keywords
- Hysterscopy, Congenital Uterine Anomaly, Uterine Septum, Septet Uterus, Novel Scoring System, Shawki Septum Scoring System
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ebtesama HospitalUniversity, hospital or other
- Study start
- 18 Nov 2018 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 21 Apr 2023 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hysteroscopic Metroplasty using ESHRE ASRM Classification | Active comparator | Diagnostic Test: ESHRE ASRM Classification |
| Hysteroscopic Metroplasty using Shawki Septum Scoring System | Active comparator | Diagnostic Test: Shawki Septum Scoring System |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Uterine Septum diagnosed by 3D ultrasound
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shawki Septum Scoring SystemUtilising the novel scoring system to facilitate feasibility and safety of hysteroscopic metroplasty for uterine septum | Diagnostic test | Hysteroscopic Metroplasty using Shawki Septum Scoring System |
| ESHRE ASRM ClassificationUtilising the current classification before performing hysteroscopic metroplasty | Diagnostic test | Hysteroscopic Metroplasty using ESHRE ASRM Classification |
Primary outcome
Number of patients with Complete Septum Correction
Time frame: 1 month
No residual septum on 3D ultrasound
Percentage of patients who had an intra-operative Uterine perforation
Time frame: during the surgery
Diminishing the risk of intra-operative perforation of the fundus
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
- Results publication: PubMed 30290803Rikken 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.
- Results publication: PubMed 27235766Practice 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: 10.1016/j.fertnstert.2016.05.014. Epub 2016 May 25.
- Results publication: PubMed 36832295Alcazar 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.
- Results publication: PubMed 33793794Rikken 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.
- Results publication: PubMed 20492650Nouri 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.
- Results publication: PubMed 12870384Agostini 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.
- Individual participant dataSharing planned: Yes
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Intrauterine Adhesion
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Added Value of Three-dimensional Transvaginal Ultrasound (3D TVUS) and Gel Infusion Sonography (3D GIS) Compared With Magnetic Resonance Imaging (MRI) in the Diagnosis of Patients With Suspicion of a Uterine Septum.
Uterine Septum
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.
Yehia Shawki, MRCOG principal investigator
Endo-Planet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shawki Septum Scoring System and ESHRE ASRM Classification in people with Septate Uterus, run by Ebtesama Hospital at 1 site in Egypt.
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 1 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: status not confirmed, as of the sponsor's last update on 21 Apr 2023. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yehia Shawki, MRCOG (00201001226662, yehiaoshawki@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with Complete Septum Correction (time frame: 1 month). The study lists 2 primary outcomes in all. 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 NCT05823103, which also lists 6 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 21 Apr 2023; AzTrials last refreshed its copy on 6 Nov 2026.