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Enrolling by invitation NCT07736859

Satisfaction of Hysterosalpingo-Foam Sonography

Observational Infertility

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Infertility. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

To evaluate patient satisfaction following a HyFoSy examination performed as part of a fertility workup, by assessing the procedure's tolerability through a questionnaire administered immediately after the examination.

Detailed description

Tubal patency testing is an essential component of the fertility work-up. Worldwide, infertility currently affects 5-15% of couples. Tubal occlusion is one of the leading causes of female infertility, accounting for approximately 26% of cases.

Assessment of tubal patency is crucial for diagnosing tubal obstruction before initiating fertility treatment, including intrauterine insemination (IUI) or in vitro fertilization (IVF). It is also important for documenting the success of tubal recanalization following tubal reconstructive surgery. Furthermore, tubal patency assessment plays a key role in fertility counseling for women.

Laparoscopy with chromopertubation has long been considered the gold standard for evaluating tubal patency; however, its main limitation is its invasive nature. Hysterosalpingography (HSG) was the first non-surgical alternative developed for tubal patency testing. Potential adverse effects include infection, allergic reactions to iodinated contrast media, vasovagal reactions related to procedural pain, and uterine or cervical perforation. In addition, HSG exposes patients to ionizing radiation, with an estimated dose of approximately 5 mGy per examination.

HyFoSy can therefore be incorporated into the routine fertility assessment following a pelvic ultrasound examination. Patients are placed in the Trendelenburg position, after which a pelvic examination is performed to insert the catheter and inject the contrast medium. This allows simultaneous evaluation of the uterine cavity, tubal patency, and ovaries during a single, radiation-free procedure.

In this prospective study, the investigators aim to expand upon these findings by investigating several aspects of the patient experience that remain poorly described in the literature, including :

* the quality of information provided before the examination * patients' overall experience and pre-procedural anxiety * the specific stages of the procedure associated with pain * the relationships between patients' experiences, their individual characteristics, and their healthcare pathways

Primary outcome measures

  • Satisfaction level [Time frame: 30 minutes per participant (including time to provide study information and complete the questionnaire)]
Secondary outcome measures (6)
  • Proportion of patients who received the information sheet and their satisfaction score with the information provided. [Time frame: 30 minutes per participant (including time to provide study information and complete the questionnaire)]
  • Distribution of pre-examination anxiety levels. [Time frame: 30 minutes per participant (including time to provide study information and complete the questionnaire)]
  • Proportion of painful experiences at each step of the procedure, and mean pain intensity during and after the examination (numerical rating scales). [Time frame: 30 minutes per participant (including time to provide study information and complete the questionnaire)]
  • Correlation between overall satisfaction score and patient characteristics and care pathways (sociodemographic data, gynecological and obstetric history, and medical and surgical history). [Time frame: 30 minutes per participant (including time to provide study information and complete the questionnaire)]
  • Correlation between overall satisfaction score and pain intensity. [Time frame: 30 minutes per participant (including time to provide study information and complete the questionnaire)]
  • Comparison between anticipated experience of the examination and actual overall experience. [Time frame: 30 minutes per participant (including time to provide study information and complete the questionnaire)]

Eligibility criteria

Inclusion criteria

  • Provided verbal informed consent after receiving full information about the study procedures
  • Women
  • Aged 18 years or older
  • Attending the fertility medicine unit and undergoing a HyFoSy ultrasound examination
  • Affiliated with, or covered by, a social security health insurance scheme

Exclusion criteria

  • Pregnant women
  • Women who are breastfeeding or in the postpartum period
  • Non-emancipated minors
  • Adults under legal protection (guardianship, curatorship, or judicial protection)
  • Adults unable to provide informed consent
  • Individuals deprived of liberty by judicial or administrative decision
  • Individuals receiving involuntary psychiatric care
  • Individuals who have declined participation in the study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • CHRU Nancy — Nancy

Identifiers

NCT: NCT07736859 · 2026-A00313-48

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗