InfertilitySat-HyFoSyNCT07736859
Satisfaction of Hysterosalpingo-Foam Sonography
An observational study of Infertility, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Infertility
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2026to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women attending the fertility medicine unit who underwent a HyFoSy ultrasound examination.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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
- Conditions
- Infertility
- Keywords
- Infertility, HyFoSy, Satisfaction
- Medical subject headings
- Infertility, Personal Satisfaction
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes per participant (including time to provide study information and complete the questionnaire)
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 30 minutes per participant (including time to provide study information and complete the questionnaire)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mikael AGOPIANTZ, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07736859
- Sponsor's protocol ID
- 2026-A00313-48
- Acronym
- Sat-HyFoSy
- Status last verified
- Jul 2026
- First submitted
- 17 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Satisfaction of Hysterosalpingo-Foam Sonography
- ClinicalTrials.gov ID
- NCT07736859
- Acronym / sponsor ID
- Sat-HyFoSy / 2026-A00313-48
- Conditions
- Infertility
- Keywords
- Infertility, HyFoSy, Satisfaction
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 30 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women attending the fertility medicine unit who underwent a HyFoSy ultrasound examination.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
6 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
Related trials for Infertility
Recruiting
Endometriosis Transcriptomic Cell Atlas
Endometriosis, Infertility
Active, not recruitingPhase 3
Human Menopausal Gonadotropin Research in Infertility Assessing Cumulative Live Birth With Frozen Embryo Transfer.
Infertility (IVF Patients)
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingPhase 2
A Study to Investigate Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea
Functional Hypothalamic Amenorrhea, FHA
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction level (time frame: 30 minutes per participant (including time to provide study information and complete the questionnaire)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.