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Набор по приглашению NCT07736859

Satisfaction of Hysterosalpingo-Foam Sonography

Наблюдательное Infertility

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Infertility. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

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.

Подробное описание

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

Первичные конечные точки

  • Satisfaction level [Срок оценки: 30 minutes per participant (including time to provide study information and complete the questionnaire)]
Вторичные конечные точки (6)
  • Proportion of patients who received the information sheet and their satisfaction score with the information provided. [Срок оценки: 30 minutes per participant (including time to provide study information and complete the questionnaire)]
  • Distribution of pre-examination anxiety levels. [Срок оценки: 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). [Срок оценки: 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). [Срок оценки: 30 minutes per participant (including time to provide study information and complete the questionnaire)]
  • Correlation between overall satisfaction score and pain intensity. [Срок оценки: 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. [Срок оценки: 30 minutes per participant (including time to provide study information and complete the questionnaire)]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 1 центр
  • CHRU Nancy — Nancy

Идентификаторы

NCT: NCT07736859 · 2026-A00313-48

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗