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

Medipol University

Status: Completed

Conditions: Infertility; Hysterosalpingography

Treatments: Diagnostic Test: Hysterosalpingography - Metal Cannula Method; Diagnostic Test: Hysterosalpingography - Active Balloon Method; Diagnostic Test: Hysterosalpingography - Passive Balloon Method

Study type: Interventional

Funder types: Other

Identifiers

NCT07583758

E-10840098-772.02-275

Details and patient eligibility

About

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.

Enrollment: 251 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: 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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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251 participants in 3 patient groups

Group 1: Metal Cannula

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: Hysterosalpingography - Metal Cannula Method

Group 2: Active Method Balloon Catheter

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: Hysterosalpingography - Active Balloon Method

Group 3: Passive Method Balloon Catheter

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: Hysterosalpingography - Passive Balloon Method