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Идёт набор NCT07119060

Ablative Technique For Ovarian Preservation In Endometrioma

Без фазы С лечением Endometrioma Fertility

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
В протоколе указаны: Cystectomy, plasma vaporization, Sclerotherapy.
Кому может быть актуально
Состояния в реестре: Endometrioma, Fertility. Базовые параметры: 18 лет — 43 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 →

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Официальное название

Monocentric, Controlled, Randomized Trial: Comparison of Pregnancy Rates in Women With One or More Endometriomas, Treated by Cystectomy, Plasma Vaporization, or Sclerotherapy

Обзор

The goal of this clinical trial is to compare pregnancy rates after different surgical treatments for endometriomas in adult women who have one or more ovarian cysts (endometriomas) larger than 2 cm requiring surgery. The main questions it aims to answer are: How many women become pregnant within 24 months after surgery ? What are the birth rates and different types of pregnancies (natural, with fertility treatments, and those continuing beyond 12 weeks)? How often do the endometriomas come back after surgery? What surgery-related complications occur? How do pain levels change after treatment? Researchers will compare different surgical treatment groups to see if one approach results in better pregnancy outcomes and fewer complications. Participants will: Be randomly assigned to different surgical treatment groups Undergo surgery for their endometriomas and endometriosis Attend follow-up visits at 3 months and 24 months after the procedure Have their pregnancy outcomes, pain levels, and potential complications monitored throughout the study period

Вмешательства

  • Процедура Cystectomy
    Surgical removal of the endometrioma by gently pulling the cyst wall away from the ovarian tissue (divergent traction technique)
  • Процедура plasma vaporization
    It consists of destroying the cyst wall (vaporization) using plasma energy
  • Процедура Sclerotherapy
    Ethanol sclerotherapy destroys the endometriotic tissue lining the inner wall of the cyst through prolonged contact with 96% alcohol

Первичные конечные точки

  • To compare pregnancy rates observed up to 24 months after surgery for endometriosis with endometrioma treatment [Срок оценки: From enrollment to 24 months after the surgery]
Вторичные конечные точки (7)
  • To compare birth rates pregnancies [Срок оценки: From enrollment to 24 months after the surgery]
  • To compare spontaneous pregnancy rates [Срок оценки: From enrollment to 24 months after the surgery]
  • To compare pregnancies achieved through assisted reproductive technology (ART) [Срок оценки: From enrollment to 24 months after the surgery]
  • To compare pregnancies progressing beyond 12 weeks of amenorrhea [Срок оценки: From enrollment to 24 months after the surgery]
  • To compare the recurrence rate of endometriomas, defined as the appearance of an endometrioma larger than 2 cm on the same ovary. [Срок оценки: From enrollment to 24 months after the surgery]
  • To compare postoperative complication rates [Срок оценки: During 3 months after the surgery]
  • To compare pain scores using the Biberoglu and Behrman scale (Biberoglu and Behrman >4) [Срок оценки: From enrollment to 24 months after the surgery]

Критерии участия

Критерии включения

  • Patient aged between 18 and 43 years (inclusive)
  • Patient diagnosed with endometriosis (by histology or imaging) and symptomatic, requiring surgery (pelvic pain and/or infertility and/or risk to an organ)
  • Pelvic MRI or ultrasound performed within the last year showing at least one endometrioma larger than 20 mm in diameter
  • Patient with an intention to conceive (probable or certain) after surgery
  • Patient informed and having signed the consent form
  • Patient covered by a social security scheme

Критерии исключения

  • Intraoperative finding that the cyst is not an endometrioma
  • Patient under guardianship, conservatorship, or incapable of giving consent
  • Patient without sufficient understanding of the French language
  • Patient under judicial protection measures
  • Patient who is pregnant or breastfeeding

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Франция · 1 центр
  • IFEMEndo - Clinique Tivoli — Bordeaux

Публикации

  • Crestani A, Merlot B, Chanavaz Lacheray I, Dennis T, Goualard PH, Roman H. ATOPE study protocol: a randomised controlled trial comparing cystectomy and plasma vapourisation in endometriomas under 6 cm, with an observational arm for sclerotherapy in larger cysts. BMJ Open. 2026 Apr 28;16(4):e112291. doi: 10.1136/bmjopen-2025-112291. PMID 42049313

Идентификаторы

NCT: NCT07119060 · CliTiv-01-2025 · 2024-A01400-47

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗