NCT07583758

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
251

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

April 25, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 13, 2026

Completed
Last Updated

May 13, 2026

Status Verified

May 1, 2026

Enrollment Period

2.7 years

First QC Date

April 25, 2026

Last Update Submit

May 6, 2026

Conditions

InfertilityHysterosalpingography

Keywords

hysterosalpingographymetal cannulaactive balloonpassive ballooninfertility

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (3)

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.

Diagnostic Test: Hysterosalpingography - Metal Cannula Method

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.

Diagnostic Test: Hysterosalpingography - Active Balloon Method

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.

Diagnostic Test: Hysterosalpingography - Passive Balloon Method

Interventions

Hysterosalpingography - Metal Cannula MethodDIAGNOSTIC_TEST

Different techniques of hysterosalpingography (HSG) were applied for 3 groups in parallel.

Group 1: Metal Cannula
Hysterosalpingography - Active Balloon MethodDIAGNOSTIC_TEST

Different techniques of hysterosalpingography (HSG) were applied for 3 groups in parallel.

Group 2: Active Method Balloon Catheter
Hysterosalpingography - Passive Balloon MethodDIAGNOSTIC_TEST

Different techniques of hysterosalpingography (HSG) were applied for 3 groups in parallel.

Group 3: Passive Method Balloon Catheter

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale patients diagnosed with infertility
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- Female patients with infertility

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University, Medipol Mega University Hospital

Istanbul, 34214, Turkey (Türkiye)

Location

Related Publications (3)

  • 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: 1584936RESULT

  • 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: 12696625RESULT

  • 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: 19632497RESULT

Related Links

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Gulseren Polat, M.D.

    Medipol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The patients didn't know which methodology will be applied.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Obstetrician and Gynecologisit

Study Record Dates

First Submitted

April 25, 2026

First Posted

May 13, 2026

Study Start

January 1, 2020

Primary Completion

August 31, 2022

Study Completion

April 25, 2026

Last Updated

May 13, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

Data is available upon reasonable request from the principal investigator, Dr. Gulseren Polat. The results are planned to be published in a medical journal.

Shared Documents
STUDY PROTOCOL
Time Frame
Patient recruitment: January 2020 - August 2022
Access Criteria
When assessed for publications, the editorial office could ask for data if required.
More information

Locations

TU(1)