Clinical Trial on the Methodology of Hysterosalpingography: a Comparative Study (MethodHSG)

May 6, 2026 updated by: Gulseren Polat, Medipol University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

251

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye), 34214
        • Istanbul Medipol University, Medipol Mega University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1: Metal Cannula
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.
Diagnostic test: Hysterosalpingography - Metal Cannula Method
Different techniques of hysterosalpingography (HSG) were applied for 3 groups in parallel.
Active Comparator: Group 2: Active Method Balloon Catheter
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.
Diagnostic test: Hysterosalpingography - Active Balloon Method
Different techniques of hysterosalpingography (HSG) were applied for 3 groups in parallel.
Active Comparator: Group 3: Passive Method Balloon Catheter
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.
Diagnostic test: Hysterosalpingography - Passive Balloon Method
Different techniques of hysterosalpingography (HSG) were applied for 3 groups in parallel.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medipol University

Collaborators

Istanbul Medipol University Hospital

Investigators

  • Principal Investigator: Gulseren Polat, M.D., Medipol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

August 31, 2022

Study Completion (Actual)

April 25, 2026

Study Registration Dates

First Submitted

April 25, 2026

First Submitted That Met QC Criteria

May 6, 2026

First Posted (Actual)

May 13, 2026

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-10840098-772.02-275

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data is available upon reasonable request from the principal investigator, Dr. Gulseren Polat.

The results are planned to be published in a medical journal.

IPD Sharing Time Frame

Patient recruitment: January 2020 - August 2022

IPD Sharing Access Criteria

When assessed for publications, the editorial office could ask for data if required.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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