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| Name | Class |
|---|---|
| Istanbul Medipol University Hospital | OTHER |
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Different techniques have been developed to optimize hysterosalpingography (HSG) methodology. Our aim is to compare the advantages and disadvantages of these three different techniques in terms of both patient satisfaction and clinician's interpretation. The medical records of the patients who are treated in our hospital between 2020 and 2022 are investigated based on the eligibility criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Metal Cannula | Active Comparator | Applied to 158 infertile women. While the patient was made to cough forcefully, a tenaculum was gently inserted into the cervix. A Rubin cannula, de-aired and filled with radiopaque, was placed in the cervical canal. The speculum was removed. Traction was applied to the tenaculum to bring the uterus into a straight position, and while radiopaque material was injected under fluoroscopy, the cavity, tubal corneum, isthmus, ampulla, and degree of spillage into the abdomen were visualized. |
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| Group 2: Active Method Balloon Catheter | Active Comparator | Applied to 50 infertile women. In this case, a balloon catheter was placed from the cervix into the uterine cavity. A 2cc balloon was inflated. The uterus was brought to a straight position by applying traction to the balloon catheter, and the cavity, tubal corneum, isthmus, ampulla, and degree of spillage into the abdomen were visualized while radiopaque material was injected under fluoroscopy guidance. The uterine isthmus was visualized while the balloon was being deflated and withdrawn. |
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| Group 3: Passive Method Balloon Catheter | Active Comparator | Applied to 43 infertile women. In this case, a balloon catheter was placed from the cervix into the uterine cavity. A 2cc balloon was inflated. While the balloon catheter was in the cavity, the tubal corneum, isthmus, ampulla, and degree of spillage into the abdomen were visualized by first injecting radiopaque material under fluoroscopy guidance. Then, the cavity was visualized while the balloon catheter was being deflated and withdrawn, and the uterine isthmus was visualized. This procedure was called the passive method balloon catheter method. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hysterosalpingography - Metal Cannula Method | Diagnostic Test | Different techniques of hysterosalpingography (HSG) were applied for 3 groups in parallel. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction | Patients' visual analogue scores (VAS) immediately after the procedure and 30 minutes post-procedure are recorded, respectively. The pain is assessed by the principal investigator. The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10 cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). | Day 1 |
| Clinician's Interpretation | The interpretation is classified as "clearly evaluated", "partially evaluated" and as "could not be evaluated" by the clinician. | Day 1 |
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Inclusion Criteria:
- Female patients with infertility
Exclusion Criteria:
Female patients diagnosed with infertility
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| Name | Affiliation | Role |
|---|---|---|
| Gulseren Polat, M.D. | Medipol University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul Medipol University, Medipol Mega University Hospital | Istanbul | 34214 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1584936 | Result | Pellerito JS, McCarthy SM, Doyle MB, Glickman MG, DeCherney AH. Diagnosis of uterine anomalies: relative accuracy of MR imaging, endovaginal sonography, and hysterosalpingography. Radiology. 1992 Jun;183(3):795-800. doi: 10.1148/radiology.183.3.1584936. | |
| 12696625 | Result | Preutthipan S, Linasmita V. A prospective comparative study between hysterosalpingography and hysteroscopy in the detection of intrauterine pathology in patients with infertility. J Obstet Gynaecol Res. 2003 Feb;29(1):33-7. doi: 10.1046/j.1341-8076.2003.00068.x. |
| Label | URL |
|---|---|
| The study protocol is approved by the university's ethics committee. | View source |
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Data is available upon reasonable request from the principal investigator, Dr. Gulseren Polat.
The results are planned to be published in a medical journal.
Patient recruitment: January 2020 - August 2022
When assessed for publications, the editorial office could ask for data if required.
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The patients didn't know which methodology will be applied.
| Hysterosalpingography - Active Balloon Method | Diagnostic Test | Different techniques of hysterosalpingography (HSG) were applied for 3 groups in parallel. |
|
| Hysterosalpingography - Passive Balloon Method | Diagnostic Test | Different techniques of hysterosalpingography (HSG) were applied for 3 groups in parallel. |
|
| 19632497 | Result | Chalazonitis A, Tzovara I, Laspas F, Porfyridis P, Ptohis N, Tsimitselis G. Hysterosalpingography: technique and applications. Curr Probl Diagn Radiol. 2009 Sep-Oct;38(5):199-205. doi: 10.1067/j.cpradiol.2008.02.003. |
| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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