Integrative Chinese and Western Medicine for Diminished Ovarian Reserve-Associated Infertility in Natural Conception Population
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Cumulative clinical pregnancy rate
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Western medicine group
Take the placebo granules orally for three months, followed by three cycles of letrozole while continuing the placebo.
干预措施: Western Medicine (Drug)
Western medicine group
Take the placebo granules orally for three months, followed by three cycles of letrozole while continuing the placebo.
干预措施: Placebo (Drug)
Integrated traditional Chinese and Western medicine
Take the "Xiehe DOR Kidney-Tonifying Universal Formula" orally for three months; thereafter, continue the Chinese herbal formula while combining it with three cycles of letrozole.
干预措施: Western Medicine (Drug)
Integrated traditional Chinese and Western medicine
Take the "Xiehe DOR Kidney-Tonifying Universal Formula" orally for three months; thereafter, continue the Chinese herbal formula while combining it with three cycles of letrozole.
干预措施: Traditional Chinese Medicine (Drug)
结局指标
主要结局
Cumulative clinical pregnancy rate
时间窗: Assessed at study completion, approximately 6 months after enrollment.
The rate of intrauterine pregnancy confirmed by transvaginal ultrasound
次要结局
- Indicators related to ovarian reserve function(Baseline, 3-months, 6-months)