An observational study in Infertility, sponsored by Central Hospital, Nancy, France. Enrolling by invitation at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by Central Hospital, Nancy, France · Observational
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.
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 :
2,085 studies on the registry are indexed under Infertility; 357 are open to participants now.
This study's planned enrollment of 200 is close to the median of 200 across 592 observational studies indexed under Infertility.
Browse Infertility studies →Central Hospital, Nancy, France is the lead sponsor of 798 studies on the registry; 186 are open to participants now.
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Women attending the fertility medicine unit who underwent a HyFoSy ultrasound examination.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria :
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Satisfaction level
To evaluate patient satisfaction following a HyFoSy examination performed as part of an infertility workup by assessing the procedure's tolerability using a questionnaire administered immediately after the examination. Participants will be asked to rate their overall satisfaction on a scale from 0 to 10, with 10 indicating the highest level of satisfaction.
Time frame: 30 minutes per participant (including time to provide study information and complete the questionnaire)
Proportion of patients who received the information sheet and their satisfaction score with the information provided.
To evaluate the quality and clarity of the information provided before the examination by assessing receipt of the information sheet, its comprehensibility, perceived usefulness, suggestions for improvement, and the use of additional sources of information.
Time frame: 30 minutes per participant (including time to provide study information and complete the questionnaire)
Distribution of pre-examination anxiety levels.
To assess apprehension related to the procedure by analyzing pre-examination anxiety levels. Participants will be asked to rate their level of anxiety before the examination as : very relaxed ; relaxed ; neutral ; anxious ; very anxious.
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).
To identify the stage(s) of the procedure associated with pain by collecting patient-reported experience at each step (initial ultrasound, speculum insertion, catheter placement, contrast medium injection, post-injection ultrasound), as well as pain intensity during and after the examination using 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).
To assess associations between patients' experience of the procedure and their characteristics and care pathways.
Time frame: 30 minutes per participant (including time to provide study information and complete the questionnaire)
Correlation between overall satisfaction score and pain intensity.
To analyze the relationship between pain and overall satisfaction.
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.
Comparaison between anticipated experience (participants will be asked to indicate how they expected the examination to be, choosing one of the following options : not painful ; unpleasant ; painful ; very painful) and actual overall experience (participants will be asked to rate their overall experience of the examination as : excellent ; good ; fair ; unsatisfactory ; very unsatisfactory).
Time frame: 30 minutes per participant (including time to provide study information and complete the questionnaire)
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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