Satisfaction of Hysterosalpingo-Foam Sonography

NCT07736859 | Enrolling By Invitation DMC

• 1 other identifier: 2026-A00313-48
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility

Keywords

Infertility; HyFoSy; Satisfaction

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  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)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women attending the fertility medicine unit who underwent a HyFoSy ultrasound examination.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU Nancy

Nancy, 54000, France

Location

MeSH Terms

Conditions

Infertility; Personal Satisfaction

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PU-PH - ART Center coordinator

Study Record Dates

• First Submitted: July 17, 2026
• First Posted: July 30, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 30, 2026

Record last verified: 2026-07

Locations

FR (1)