CHRU Nancy
Nancy, 54000, France
NCT Number: NCT07736859
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.
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Request Info18 year and older
Female
Observational
Nancy, 54000, France
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 :
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 30 minutes per participant (including time to provide study information and complete the questionnaire)
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)
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)
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)
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)
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)
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)
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).
Central Hospital, Nancy, France
Other
Acronym: Sat-HyFoSy
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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