Infertility
Conditions
Keywords
Infertility, HyFoSy, Satisfaction
Brief summary
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
Interventions
None listed
Sponsors
Central Hospital, Nancy, France
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction level | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients who received the information sheet and their satisfaction score with the information provided. | 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. |
| Distribution of pre-examination anxiety levels. | 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. |
| Proportion of painful experiences at each step of the procedure, and mean pain intensity during and after the examination (numerical rating scales). | 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. |
| Correlation between overall satisfaction score and patient characteristics and care pathways (sociodemographic data, gynecological and obstetric history, and medical and surgical history). | 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. |
| Correlation between overall satisfaction score and pain intensity. | 30 minutes per participant (including time to provide study information and complete the questionnaire) | To analyze the relationship between pain and overall satisfaction. |
| Comparison between anticipated experience of the examination and actual overall experience. | 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). |
Countries
France
Outcome results
None listed