Clinical Trial on the Methodology of Hysterosalpingography: a Comparative Study

NCT07583758 — Not applicable, Completed, 251 participants, Medipol University

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Registry	NCT07583758, acronym MethodHSG
Status	Completed
Phase	Not applicable
Study type	Interventional; non randomized, parallel, masking: single, health services research
Enrollment	251 (Actual)
Sponsor	Medipol University (Other); collaborators: Istanbul Medipol University Hospital
Conditions	Infertility, Hysterosalpingography
Interventions	Hysterosalpingography - Metal Cannula Method, Hysterosalpingography - Active Balloon Method, Hysterosalpingography - Passive Balloon Method (Diagnostic test)
Dates	start 2020-01-01, primary completion 2022-08-31, completion 2026-04-25, first posted 2026-05-13, last updated 2026-05-13
Locations	1 site in Turkey (Türkiye)

-Summary

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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+Arms and interventions

Arm	Type	Interventions	Description
Group 1: Metal Cannula	Active comparator	Diagnostic Test: Hysterosalpingography - Metal Cannula Method	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.
Group 2: Active Method Balloon Catheter	Active comparator	Diagnostic Test: Hysterosalpingography - Active Balloon Method	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.
Group 3: Passive Method Balloon Catheter	Active comparator	Diagnostic Test: Hysterosalpingography - Passive Balloon Method	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.

Hysterosalpingography - Metal Cannula Method (Diagnostic test): Different techniques of hysterosalpingography (HSG) were applied for 3 groups in parallel.
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.

+Outcome measures

Primary outcomes

Patient Satisfaction [Day 1]: 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').
Clinician's Interpretation [Day 1]: The interpretation is classified as "clearly evaluated", "partially evaluated" and as "could not be evaluated" by the clinician.

+Eligibility

Sex: Female, ages: 18 Years to 50 Years, accepts healthy volunteers

Inclusion Criteria:

\- Female patients with infertility

Exclusion Criteria:

* Male patients
* Patients who are diagnosed with menopause
* Patients who do not want to proceed with HSG for diagnosis purposes

+Locations (1)

Facility	City	Country	Status
Istanbul Medipol University, Medipol Mega University Hospital	Istanbul	Turkey (Türkiye)

+Publications

Results publication: 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. PMID 1584936
Results publication: 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. PMID 12696625
Results publication: 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. PMID 19632497

+Investigators

Gulseren Polat, M.D., Principal investigator, Medipol University

My Notes

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