InfertilityMethodHSGNCT07583758

Clinical Trial on the Methodology of Hysterosalpingography: a Comparative Study

A study testing Hysterosalpingography - Metal Cannula Method, Hysterosalpingography - Active Balloon Method and Hysterosalpingography - Passive Balloon Method in people with Infertility and Hysterosalpingography, run by Medipol University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for: Infertility, Hysterosalpingography
What is being tested?: Hysterosalpingography - Metal Cannula Method, Hysterosalpingography - Active Balloon Method and Hysterosalpingography - Passive Balloon Method
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 251 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 Jan 2020to 25 Apr 2026
Phase: Interventional
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 18 to 50 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Female patients with infertility

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Istanbul Medipol University, Medipol Mega University Hospital
Istanbul, 34214

Other trials in Turkey (Türkiye)

About this study

Conditions: Infertility, Hysterosalpingography
Being tested: Hysterosalpingography - Metal Cannula Method, Hysterosalpingography - Active Balloon Method, Hysterosalpingography - Passive Balloon Method
Keywords: hysterosalpingography, metal cannula, active balloon, passive balloon, infertility
Medical subject headings: Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hysterosalpingography - Metal Cannula MethodDiagnostic test
Different techniques of hysterosalpingography (HSG) were applied for 3 groups in parallel.
Hysterosalpingography - Active Balloon MethodDiagnostic test
Different techniques of hysterosalpingography (HSG) were applied for 3 groups in parallel.
Hysterosalpingography - Passive Balloon MethodDiagnostic test
Different techniques of hysterosalpingography (HSG) were applied for 3 groups in parallel.

Study groups in NCT07583758
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Diagnostic Test: Hysterosalpingography - Passive Balloon Method

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202025 Apr 2026

First posted13 May 2026
Study start1 Jan 2020
Primary completion31 Aug 2022
Study completion25 Apr 2026

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 InfertilityStudies of the same condition, open and under way.
More trials run by Medipol UniversityThe sponsor's other registered studies.
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: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 251 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07583758
Sponsor's protocol ID: E-10840098-772.02-275
Acronym: MethodHSG
Status last verified: May 2026
First submitted: 25 Apr 2026
Last updated: 13 May 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Data is available upon reasonable request from the principal investigator, Dr. Gulseren Polat. The results are planned to be published in a medical journal.

Publications

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.
PubMed 1584936
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.
PubMed 12696625
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.
PubMed 19632497

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Infertility trials

Study at a glance

From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Trial on the Methodology of Hysterosalpingography: a Comparative Study
ClinicalTrials.gov ID: NCT07583758
Acronym / sponsor ID: MethodHSG / E-10840098-772.02-275
Conditions: Infertility, Hysterosalpingography
Keywords: hysterosalpingography, metal cannula, active balloon, passive balloon, infertility
Study type: Interventional
Recruitment status: Completed
Enrolment: 251 participants (actual)
Lead sponsor: Medipol UniversityUniversity, hospital or other
Collaborators: Istanbul Medipol University Hospital
Study start: 1 Jan 2020 (actual)
Primary completion: 31 Aug 2022 (actual)
Study completion: 25 Apr 2026 (actual)
First posted: 13 May 2026 (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.

Study design

Primary purpose: Health services research
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
Group 1: Metal Cannula	Active comparator	Diagnostic Test: Hysterosalpingography - Metal Cannula MethodApplied 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 MethodApplied 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 MethodApplied 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.

Who may qualify

Ages: 18 to 50 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Female patients with infertility

Key exclusion criteria (3 listed)

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

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
Hysterosalpingography - Metal Cannula MethodDifferent techniques of hysterosalpingography (HSG) were applied for 3 groups in parallel.	Diagnostic test	Group 1: Metal Cannula
Hysterosalpingography - Active Balloon MethodDifferent techniques of hysterosalpingography (HSG) were applied for 3 groups in parallel.	Diagnostic test	Group 2: Active Method Balloon Catheter
Hysterosalpingography - Passive Balloon MethodDifferent techniques of hysterosalpingography (HSG) were applied for 3 groups in parallel.	Diagnostic test	Group 3: Passive Method Balloon Catheter

Primary outcome

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').
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.

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 May 2026.
Results publication: PubMed 1584936Pellerito 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.
Results publication: PubMed 12696625Preutthipan 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.
Results publication: PubMed 19632497Chalazonitis 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.
The study protocol is approved by the university's ethics committee.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Data is available upon reasonable request from the principal investigator, Dr. Gulseren Polat. The results are planned to be published in a medical journal.

Related trials for Infertility

RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
RecruitingObservational study
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RecruitingObservational study
Pilot Study of Discarded Blastocysts
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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.

Gulseren Polat, M.D. principal investigator

Medipol University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 1 inclusion and 3 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 May 2026. 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 Turkey (Türkiye). 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?

Patient Satisfaction (time frame: Day 1). The study lists 2 primary outcomes in all. 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 NCT07583758, 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 May 2026.