Asherman SyndromeNCT05901948
Pre-Surgical Grading System of Asherman Syndrome
An observational study of Asherman Syndrome, run by Ebtesama Hospital at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Asherman Syndrome
- What is being tested?
- Classification
- How many people
- 65 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Jan 2020to 15 Mar 2023
- Phase
- Observational
- 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
Study population: Patients complaining of hypomenorrhea, amenorrhea or infertility, who have a hysterosalpingography confirming intrauterine adhesions (Asherman Syndrome)
Who may be able to join
- Asherman Syndrome
- intra-uterine synechiae
Who cannot join
- patients with a fundectomy or uterine reduction surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Asherman Syndrome
- Being tested
- Classification
- Keywords
- Asherman Syndrome, Hysteroscopy, Intra-Uterine Surgery, Intra-Uterine Adhesions, Classification
- Medical subject headings
- Gynatresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClassificationOther
Novel Asherman Scoring Classification
| Study group | Role | What they receive |
|---|---|---|
| Asherman Patients | Patients diagnosed with Asherman syndrome based on patient complaint of hypomenorrhea or amenorrhea and hysterosalpingography. Receives: Other: Classification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Resumption of normal cavity on hystero-salpingography
assessing the improvement of the cavity of the uterus in hystero-salpingography
Measured: 1 month
Secondary outcomes (1)
Menses
Improvement in patients menstrual cycle
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2023
- Study start7 Jan 2020
- Primary completion31 Jan 2023
- Study completion15 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Asherman SyndromeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ebtesama Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yehia Shawki, Ebtesama Hospital
- Investigators
- Osama Shawki, MD, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05901948
- Sponsor's protocol ID
- 100032023002
- Status last verified
- Jun 2023
- First submitted
- 4 Jun 2023
- Last updated
- 13 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sharing IPD in an effort to garner more research and interest in the field
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.
PubMed 30936754Salazar 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.
PubMed 28582327Di 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.
PubMed 32444259
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asherman Syndrome: Pre-surgical Grading to Improve Gauge Prognostic Values and Improve Outcomes
- ClinicalTrials.gov ID
- NCT05901948
- Acronym / sponsor ID
- 100032023002
- Conditions
- Asherman Syndrome
- Keywords
- Asherman Syndrome, Hysteroscopy, Intra-Uterine Surgery, Intra-Uterine Adhesions, Classification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Ebtesama HospitalUniversity, hospital or other
- Study start
- 7 Jan 2020 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 13 Jun 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asherman Patients | – | Other: ClassificationPatients diagnosed with Asherman syndrome based on patient complaint of hypomenorrhea or amenorrhea and hysterosalpingography. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients complaining of hypomenorrhea, amenorrhea or infertility, who have a hysterosalpingography confirming intrauterine adhesions (Asherman Syndrome)
Key inclusion criteria (2 listed)
- Asherman Syndrome
- intra-uterine synechiae
Key exclusion criteria (1 listed)
- patients with a fundectomy or uterine reduction surgery.
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 |
|---|---|---|
| ClassificationNovel Asherman Scoring Classification | Other | Asherman Patients |
Primary outcome
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 secondary outcome
Menses
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
- Results publication: PubMed 30936754Dreisler 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.
- Results publication: PubMed 28582327Salazar 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.
- Results publication: PubMed 32444259Di 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.
- Individual participant dataSharing planned: Yes. Sharing IPD in an effort to garner more research and interest in the field
Related trials for Asherman Syndrome
RecruitingObservational study
Senescent Endometrial Cells in Patients With Thin Endometrial Lining
Asherman's Syndrome, Thin Endometrial Lining
Recruiting
CURENDO (Cord-blood Uterine Regeneration Endometrium): Platelet-rich Plasma Therapy Derived From Umbilical Cord Blood for the Treatment of Endometrial Pathologies (Asherman Syndrome / Endometrial Atrophy / Thin Endometrium)
Asherman Syndrome
RecruitingPhase 1
AD-SVF Therapy for Refractory Endometrial Infertility
Endometrium; Atrophy, Intrauterine Synechiae
RecruitingEarly Phase 1
Bone Marrow Derived Stem Cells Mobilization for Treatment of Abnormal Endometrium
Asherman Syndrome, Atrophic Endometrium
Not yet recruitingObservational study
Safety and Performance of the Semical Adhesion Barrier Gel for Prevention of Intra-uterine Adhesion
Intrauterine Abnormalities in Infertility, Asherman Syndrome
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.
Osama Shawki, MD study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asherman Syndrome, 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 2 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: finished, as of the sponsor's last update on 13 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Resumption of normal cavity on hystero-salpingography (time frame: 1 month). 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 NCT05901948, which also lists 3 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 13 Jun 2023.