Меню
Набор скоро начнётся NCT07737847

Clinical Study on ShouTai Pills for Improving Reduced Ovarian Reserve

Без фазы С лечением Diminished Ovarian Reserve (DOR)

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: Shoutai Pill, Placebo.
Кому может быть актуально
Состояния в реестре: Diminished Ovarian Reserve (DOR). Базовые параметры: 20 лет — 50 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

A Study on Biological Subtyping of Reduced Ovarian Reserve With Kidney Essence Deficiency Syndrome Based on Follicular Fluid Metabolomics and Efficacy Prediction of ShouTai Pills

Обзор

Grounded in the 'disease-syndrome combination' paradigm, this study endeavors to address the pivotal scientific issues pertaining to the clinical precision of Traditional Chinese Medicine (TCM) in managing Diminished Ovarian Reserve (DOR) classified as the Kidney Essence Deficiency type, through the application of systems biology technologies, including metabolomics.

Вмешательства

  • Препарат Shoutai Pill
    The experimental group took Shoutai Pills, 20 pills each time, twice daily, taken with water, continuously for 3 months
  • Препарат Placebo
    The experimental group took placebo Pills, 20 pills each time, twice daily, taken with water, continuously for 3 months

Первичные конечные точки

  • Number of MII oocyte [Срок оценки: After 3 months of medication, ovulation induction was performed, followed by oocyte retrieval upon completion of the induction cycle. The number of mature oocytes was recorded on the day of retrieval.]
Вторичные конечные точки (6)
  • FSH [Срок оценки: Basline， and after 3 months of treatment]
  • AMH [Срок оценки: Basline， and after 3 months of treatment]
  • number of oocytes retrieved [Срок оценки: After 3 months of medication, ovulation induction was performed, followed by oocyte retrieval upon completion of the induction cycle. The number of mature oocytes was recorded on the day of retrieval.]
  • AFC [Срок оценки: Basline， and after 3 months of treatment]
  • blastocyst formation rate [Срок оценки: After 3 months of medication, ovulation induction and oocyte retrieval for fertilization are performed, recorded as Day 0. Blastocysts form on days 5/6 post-fertilization; thus, the blastocyst formation rate is assessed on Day 6]
  • proportion of good-quality embryos [Срок оценки: After 3 months of medication, ovulation induction and oocyte retrieval for fertilization are performed, recorded as Day 0. Cleavage embryos form on day3 post-fertilization; thus, the rate is assessed on Day 3]

Критерии участия

Критерии включения

  • The inclusion criteria are as follows: ① meeting the above-mentioned integrated Chinese and Western medicine diagnostic criteria for DOR
  • ② no use of estrogen-containing medications within the past 1 month
  • ③ patients scheduled to undergo IVF-ET
  • ④ provision of signed informed consent, voluntary participation, and good compliance.

Критерии исключения

  • The exclusion criteria are as follows: ① patients with polycystic ovary syndrome (PCOS) or stage III/IV endometriosis
  • ② uterine conditions including untreated submucous myomas, intramural myomas >4 cm in diameter, intrauterine adhesions, uterine septum, or other uterine anomalies
  • ③ couples undergoing preimplantation genetic diagnosis (PGD) for genetic reasons
  • ④ body mass index (BMI) ≥28 kg/m²
  • ⑤ history of prior pelvic radiotherapy or cytotoxic chemotherapy
  • ⑥ significant systemic diseases, such as uncontrolled hypertension, diabetes mellitus, thyroid dysfunction, hepatic or renal insufficiency, cardiac disorders, or autoimmune diseases
  • ⑦ use of medications that may interfere with this study within the past 1 month, including but not limited to estrogens, hepatic enzyme modulators, and agents that may affect the endocrine system (hormonal drugs)
  • ⑧ known allergy to any components of the study medication
  • and ⑨ participation in another drug trial within the past 3 months. -

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
Простое слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Peking Union Medical College Hospital — Пекин

Идентификаторы

NCT: NCT07737847 · I-26PJ0867 · 首发 2026-2-4019

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗