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Clinical Trials in China / NCT07296614
Starting soon Phase 3

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

NCT07296614 · tracked via the Priya Life Science China tracker
Sponsor
Peking Union Medical College Hospital
Phase
Phase 3
Started
2025-12-25
Last updated
2025-12-22

Condition(s) studied

Diminished Ovarian Reserve (DOR)Infertility

Investigational drug(s) / intervention(s)

Western MedicineTraditional Chinese MedicinePlacebo

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).

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.

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.

Study 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).

Eligibility

Sex
FEMALE
Min age
22 Years
Max age
39 Years
Healthy volunteers
No
Inclusion Criteria: 1. Female patients aged 22 to 39 years (inclusive). 2. 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). 3. Meet the diagnostic criteria for kidney deficiency syndrome in traditional Chinese medicine 4. Voluntarily participate in this study and provide written informed consent. Exclusion Criteria: 1. 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; 2. Infertility caused by organic lesions of the fallopian tubes, uterus, cervix, etc. 3. Infertility due to male factors (based on semen analysis reports, meeting the diagnostic criteria for oligoasthenoteratozoospermia according to the WHO 5th edition standards). 4. DOR caused by iatrogenic factors (such as pelvic surgery, radiotherapy/chemotherapy, uterine artery embolization, etc.). 5. Patients with severe primary diseases of the cardiovascular, cerebrovascular, hepatic, renal, or hematopoietic systems, or psychiatric disorders. 6. Individuals with known allergies to the investigational drug or its components. 7. 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. 8. Patients currently participating in or planning to participate in other clinical trials.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Peking union medical college hospital Beijing Beijing Municipality

More Peking Union Medical College Hospital trials in China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07296614 on ClinicalTrials.gov ↗ ← All trials in China