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Набор скоро начнётся NCT07468331

Egg Donation at the Assisted Reproductive Technology (ART) Center of the Nancy University Hospital

— Наблюдательное Egg Donation Infertility Assisted Reproductive Technology

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: Egg Donation, Infertility Assisted Reproductive Technology. Базовые параметры: 18 лет — 38 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
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Официальное название

DONOVO-Nancy: Egg Donation at the Assisted Reproductive Technology (ART) Center of the Nancy University Hospital: an Overview of the Donor Journey Since the Revisions to the Bioethics Laws

Обзор

Since the 2021 revision of French bioethics laws, access to assisted reproductive technologies (ART) has expanded, leading to a significant increase in gamete donation requests. In this context, oocyte donation remains a limited resource, with marked disparities between centers and persistent donor shortages. At the Assisted Reproductive Technology Center of Nancy University Hospital, more than fifty women have initiated an oocyte donation process since the implementation of the new legislation. However, not all candidates complete the donation pathway, and clinical and organizational outcomes have not yet been formally evaluated. This retrospective observational study will evaluate the oocyte donation pathway at the Assisted Reproductive Technology Center of Nancy University Hospital. The study population will include all women who attended a biological consultation for primary or secondary oocyte donation from the implementation of the new Bioethics laws until December 31, 2025 (study period). Baseline clinical and biological characteristics of donor candidates will be described, including age, body mass index, anti-Müllerian hormone level, and antral follicle count. The proportion of donor candidates undergoing oocyte retrieval and the time interval between the first biological consultation and oocyte retrieval will be assessed. Biological and clinical outcomes will also be analyzed, including the number of oocytes retrieved, the number of mature oocytes (metaphase II) obtained, fertilization rate following in vitro fertilization, clinical pregnancy rate per embryo transfer, and live birth rate. Results will be compared with national data reported by the French Biomedicine Agency in order to evaluate the activity and outcomes of the center and to identify potential areas for organizational and clinical improvement in the oocyte donation pathway. The overall objective is to optimize donor management and improve access to oocyte donation for recipient patients.

Первичные конечные точки

  • Proportion of donor candidates undergoing oocyte retrieval [Срок оценки: From the first biological consultation until oocyte retrieval, assessed up to 12 months]
Вторичные конечные точки (6)
  • Mean number of oocytes retrieved per oocyte retrieval procedure [Срок оценки: At the time of oocyte retrieval procedure, approximately 14-16 days after the start of ovarian stimulation]
  • Mean time from first biological consultation to oocyte retrieval [Срок оценки: From the first biological consultation until oocyte retrieval, assessed up to 12 months]
  • Median number of mature oocytes (metaphase II) retrieved per donor [Срок оценки: At the time of oocyte retrieval procedure, approximately 14-16 days after the start of ovarian stimulation]
  • Fertilization rate following in vitro fertilization or intracytoplasmic sperm injection [Срок оценки: 1 day after fertilization]
  • Clinical pregnancy rate per embryo transfer [Срок оценки: From embryo transfer until confirmation of clinical pregnancy by ultrasound, assessed up to 8 weeks after embryo transfer]
  • Live birth rate following oocyte donation cycles [Срок оценки: From embryo transfer until delivery, assessed up to 41 weeks of gestation]

Критерии участия

Критерии включения

  • All women who attended a biological consultation for primary or secondary oocyte donation at Nancy University Hospital during the study period.

Критерии исключения

  • Absence of biological consultation for oocyte donation during the study period ;
  • Insufficient or missing medical data ;
  • Documented opposition to data use for research purposes.

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
  • University Hospital of Nancy (CHRU Nancy) — Nancy

Идентификаторы

NCT: NCT07468331 · 2026PI052

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗