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Идёт набор NCT06360471

Fertility Preservation and Pregnancy and Offspring Health Outcomes in Female Cancer

— Наблюдательное Fertility Issues Cancer

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: fertility preservation.
Кому может быть актуально
Состояния в реестре: Fertility Issues, Cancer. Базовые параметры: 20 лет — 40 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
Китай
Следующий шаг
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Официальное название

Fertility Preservation and Pregnancy and Offspring Health Outcomes in Female Cancer Patients: A Multicenter, Prospective, Cohort Study

Обзор

To explore whether there is a significant difference in the cumulative live birth rate and maternal and child health outcomes between cancer patients who undergo or do not undergo fertility preservation before receiving anti-tumor treatment and non-cancer patients who undergo assisted reproductive technology treatment/natural pregnancy. This study will be conducted in the Clinical Center of Reproductive Medicine, First Affiliated Hospital of Nanjing Medical University. 2800 women diagnosed with malignant cancers who has desire to reproduce will be enrolled in this study. Statistical analysis of the data will be performed.

Подробное описание

The number of new cancer cases among Chinese women in 2020 will be 2.09 million, showing a trend in younger age at the time of diagnosis. Incomplete statistics show that 25%\~30% of young breast cancer patients in China Need for fertility preservation. In this study, we want to answer the question: Does fertility preservation affect the prognosis in female cancer patients.

This study will be conducted in the Clinical Center of Reproductive Medicine, First Affiliated Hospital of Nanjing Medical University. 2800 women diagnosed with malignant cancers who has desire to reproduce will be enrolled in this study.

If a female tumor patients (focusing on: breast cancer, hematological diseases/lymphoma, gynecological tumors (ovarian borderline tumors, etc.), nasopharyngeal cancer, colorectal cancer, etc.) have a desire to reproduce in the future, she would considered for enrollment. After being admitted into this study, according to the patients'own will, she will receive long term observation or fertility preservation followed by long term observation. Cumulative live birth rate, perinatal and perinatal complications, and offspring health of women who have or have not received fertility preservation before anti-tumor treatment and who have no tumor and who normally receive assisted reproductive technology treatment/natural pregnancy are all recorded, to assess the impact of the current new anti-tumor treatment on female fertility and offspring health.

Вмешательства

  • Другое fertility preservation
    If a patient have a desire to fertility preservation, oocyte freezing or embryo freezing will be offered.

Первичные конечные точки

  • 5-year cumulative live birth rate [Срок оценки: 5 years]
Вторичные конечные точки (5)
  • Ovarian function(AMH levels) [Срок оценки: 5 years]
  • Ovarian function(AFC counts) [Срок оценки: 5 years]
  • Newborn malformation rate [Срок оценки: 5 years]
  • Tumor recurrence rate [Срок оценки: 5 years]
  • Tumor survival rate [Срок оценки: 5 years]

Критерии участия

Критерии включения

  • Tumor confirmed (main focus: breast cancer, hematological disease/lymphoma, gynecological tumor (ovarian cancer), boundary tumors, nasopharyngeal cancer, colorectal cancer, and other tumors that require anti-tumor treatment;
  • Having a desire for future fertility(including women who have already given birth);
  • Age: 20-40 years old (patients planning to freeze their eggs are ≤35 years old, and those planning to freeze their embryos are ≤40 years old);
  • Consent.

Критерии исключения

  • Patients with congenital or acquired uterine abnormalities, severe intrauterine adhesions, and other diseases that have a clear impact on pregnancy;
  • Those with assisted reproductive technology and pregnancy contraindications;
  • Tumors that are not suitable for pregnancy after multidisciplinary discussions on tumor fertility;
  • Clinical diagnosis of POI (premature ovarian insufficiency).

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

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Clinical Center of Reproductive Medicine of First Affiliated Hospital with Nanjing Medical — Нанкин

Идентификаторы

NCT: NCT06360471 · FS-FMC

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗