Clinical Evaluation of Integrated Chinese-Western Medicine for Infertility With DOR Patients in W… (NCT07296614) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Clinical Evaluation of Integrated Chinese-Western Medicine for Infertility With DOR Patients in Women Achieving Natural Pregnancy
China320 participantsStarted 2025-12-25
Plain-language summary
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).
Who can participate
Age range22 Years – 39 Years
SexFEMALE
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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).
What they're measuring
1
Cumulative clinical pregnancy rate
Timeframe: Assessed at study completion, approximately 6 months after enrollment.
✕. 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.