Traditional Chinese Medicine for Asthenozoospermia and Oligoasthenozoospermia: A Scoping Review of Registered Intervention Trials in Major Trial Registries
CaiYuZhu Wen, ZhiXu Chen, ZhenFei Jin, LiNa Zhao, YaFei Liu, JianShe ChenObjective
To systematically map registered interventional trials of traditional Chinese medicine (TCM) for asthenozoospermia and oligoasthenozoospermia across major international trial registries.
Methods
We systematically searched the Chinese Clinical Trial Registry (ChiCTR), the International Traditional Medicine Clinical Trial Registry (ITMCTR), the European Union Drug Regulating Authorities Clinical Trials Database (EudraCT), the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) and ClinicalTrials.gov from inception to December 31, 2025. We included all clinical trials evaluating TCM interventions (including Chinese herbal medicine, acupuncture, or their combinations) for asthenozoospermia or oligoasthenozoospermia. Two investigators independently screened records, extracted data, and cross-verified results.
Results
A total of 35 eligible trials were identified. Geographically, 32 trials (91.4%) were conducted in China, of which 30 (85.7%) were registered in ChiCTR or ITMCTR. Institutionally, Beijing (15 trials) and Shanghai (5 trials) led the distribution. Annual registrations showed a steady upward trend from 2020. Most trials (33, 94.3%) adopted randomized parallel-group designs, although single-center studies dominated (27 trials, 77.1%). Blinding was severely underreported, particularly among trials registered in ChiCTR and ITMCTR. Chinese herbal formulas/extracts were the most common intervention (25, 71.4%). The target population was predominantly males aged 22–45 years. Most trials (>80%) had planned sample sizes of 60-160 participants. Notably, more than half of the registered trials (19 trials, 54.3%) had not yet started recruitment, and only 4 trials (11.4%) had published protocols or results.
Conclusion
Clinical research on TCM for asthenozoospermia and oligoasthenozoospermia has reached a certain scale, predominantly employing randomized parallel-group designs. However, the evidence base remains geographically concentrated and largely incomplete, highlighting an urgent need to translate registered research into actionable clinical evidence.