A double-blinded, randomized placebo-controlled trial on the effect of traditional Chinese medicine formula Wuzi Yanzong pill on improving semen qualities in men with suboptimal parameters.

BACKGROUND: In Hong Kong, one of six couples is affected by subfertility problems. Male infertility contributes to half of the infertility cases. In male infertility, there is no effective treatment for patients with idiopathic infertility/poor semen parameters. Recent meta-analysis results suggest that a traditional Chinese medicine (TCM) formula - Wuzi Yanzong pill - showed a curative effect on male fertility. However, the heterogeneity of the studies could not draw a definitive conclusion on the therapeutic effect of this formula. The aim of this study is to conduct a well-designed randomized controlled trial to investigate the effect of TCM formula Wuzi Yanzong pill on improving semen qualities in men with suboptimal parameters. METHODS: This study is a double-blinded, randomized placebo-controlled trial conducted in a public hospital in Hong Kong. Participants will be randomized, using computer-generated random numbers, with a 1:1 ratio to either the Wuzi Yanzong pill formula group or the placebo group. Both groups will be administered the drugs for 12 weeks. Participants will have a total of four visits for their semen and blood assessments for a 6-month period, and we will follow up for another 6 months to record their conception outcome. The primary outcome is to compare the total motile sperm count, natural conception rate, and pregnancy outcome to those under placebo treatment. Secondary objectives are sperm functions and assisted reproductive technology outcome. DISCUSSION: To date, there are no studies using the disclosed Wuzi Yanzong formula or double-blinded, randomized trials. The Wuzi Yanzong TCM formula may provide a good clinical solution for subfertile males for which contemporary western medicine has no cure. Therefore, a well-designed randomized trial for evaluating the effect of Wuzi Yanzong TCM formula is urgently needed. TRIAL REGISTRATION: Chinese Clinical Trial Registry (ChiCTR), ChiCTR-INR-17010790 . Registered on 27 February 2017. Centre for Clinical Research and Biostatistics - Clinical Trials Registry, CUHK_CCRB00548 . Registered on 27 February 2017.

The impact of music therapy on pain and stress reduction during oocyte retrieval - a randomized controlled trial.

RESEARCH QUESTION: Does music therapy help in reducing pain and anxiety in women undergoing transvaginal ultrasound-guided oocyte retrieval (TUGOR)? DESIGN: In this randomized controlled open label study, 209 participants were recruited and randomized into three groups (music group, n = 70; headphone group, n = 70; control group, n = 69). Patients' psychological status was assessed using the visual analogue scale of pain (VAS-P), satisfaction of pain control, state-trait anxiety inventory (STAI), Beck depression inventory (BDI), and general health questionnaire (GHQ). Stress biomarkers, including salivary alpha amylase (sAA) and salivary cortisol (sCort), were measured before and after TUGOR. RESULTS: No significant differences were found in psychological scoring of STAI, BDI, GHQ and the stress biomarkers. Although neither the anxiety scores nor the analgesic requirements differed among the three groups, the visual measure of vaginal pain (median, range) showed music group (20,0-70) was significantly (P = 0.005) lower than headphone group (30,0-90) and control group (30,0-100). The degree of satisfaction with pain control (median, range) in the music group (80,30-100), was significantly (P = 0.001) higher than the headphone group (80,10-100) and control group (70,0-100). CONCLUSION: Music is a simple, inexpensive and effective way to reduce pain score and increase satisfaction with pain control during TUGOR procedure, which may justify its routine use.