Satisfaction of Hysterosalpingo-Foam Sonography
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Satisfaction level
Study Overview
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 :
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Provided verbal informed consent after receiving full information about the study procedures
- •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
Outcomes
Primary Outcomes
Satisfaction level
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.
Secondary Outcomes
- 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))
- Distribution of pre-examination anxiety levels.(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).(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).(30 minutes per participant (including time to provide study information and complete the questionnaire))
- Correlation between overall satisfaction score and pain intensity.(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.(30 minutes per participant (including time to provide study information and complete the questionnaire))
Investigators
Mikael AGOPIANTZ
PU-PH - ART Center coordinator
Central Hospital, Nancy, France