Clinical Evaluation of Integrated Chinese-Western Medicine for Infertility With DOR Patients in Women Achieving Natural Pregnancy

Официальное название

Integrative Chinese and Western Medicine for Diminished Ovarian Reserve-Associated Infertility in Natural Conception Population

Обзор

This study aims to evaluate the superiority of an integrated traditional Chinese and Western medicine regimen ("Xiehe DOR Bushen Tongzhi Formula" + ovulation induction therapy with ovulation monitoring and timed intercourse) compared to standard treatment alone (placebo + ovulation induction therapy with ovulation monitoring and timed intercourse) in improving the natural cumulative clinical pregnancy rate in infertile patients with kidney deficiency-type diminished ovarian reserve (DOR).

Вмешательства

• Препарат Western Medicine
  Letrozole is administered orally at 2.5 mg once daily from Day 2 to Day 5 of the menstrual cycle (5 consecutive days).
• Препарат Traditional Chinese Medicine
  "Xiehe DOR Kidney-Tonifying Universal Formula" is a traditional Chinese medicine (TCM) granule formulation prepared in-hospital. It is taken by dissolving one sachet in hot water, three times daily.
• Препарат Placebo
  The appearance and packaging of the placebo are exactly the same as those of "Xiehe DOR Kidney-Tonifying Universal Formula". It is also taken by dissolving one sachet in hot water, three times daily.

Первичные конечные точки

• Cumulative clinical pregnancy rate [Срок оценки: Assessed at study completion, approximately 6 months after enrollment.]

Вторичные конечные точки (1)

• Indicators related to ovarian reserve function [Срок оценки: Baseline, 3-months, 6-months]

Критерии участия

Критерии включения

• Female patients aged 22 to 39 years (inclusive).
• Meet the diagnostic criteria for diminished ovarian reserve (requiring at least two of the following: Basal FSH 10-25 IU/L; AMH < 1.1 ng/mL; AFC < 7) and infertility(defined as the failure to achieve pregnancy after 12 months of regular unprotected sexual intercourse).
• Meet the diagnostic criteria for kidney deficiency syndrome in traditional Chinese medicine
• Voluntarily participate in this study and provide written informed consent.

Критерии исключения

• Patients with premature ovarian insufficiency or premature ovarian failure (basal FSH >25 IU/L), organic pathologies such as ovarian tumors, endometrial tuberculosis, intrauterine adhesions, or endometrial injuries, as well as those with congenital adrenal hyperplasia or Cushing's syndrome;
• Infertility caused by organic lesions of the fallopian tubes, uterus, cervix, etc.
• Infertility due to male factors (based on semen analysis reports, meeting the diagnostic criteria for oligoasthenoteratozoospermia according to the WHO 5th edition standards).
• DOR caused by iatrogenic factors (such as pelvic surgery, radiotherapy/chemotherapy, uterine artery embolization, etc.).
• Patients with severe primary diseases of the cardiovascular, cerebrovascular, hepatic, renal, or hematopoietic systems, or psychiatric disorders.
• Individuals with known allergies to the investigational drug or its components.
• Use of hormonal medications (e.g., estrogen, contraceptive drugs) within one month prior to enrollment, or use of kidney-tonifying Chinese herbal medicines or proprietary Chinese medicinal products within one month prior to enrollment.
• Patients currently participating in or planning to participate in other clinical trials.

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

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Peking union medical college hospital — Пекин

Идентификаторы

NCT: NCT07296614 · K9220

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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