[Intervention of controlled ovarian hyperstimulation cycle by Chinese medical herbs for Shen tonifying, blood nourishing and activating: a randomized clinical trial].

OBJECTIVE: To study the effect of Chinese medical herbs for Shen tonifying, blood nourishing and activating (CMHSTBNA) on the cycle of controlled ovarian hyperstimulation (COH) of assisted reproductive technique (ART). METHODS: A large sample randomized control trial was performed. Infertility women patients, younger than 42 years (infertility due to tubal factor and/or male factor) were randomly assigned to the CMHSTBNA intervention group (abbreviated as the treated group) and the control group, 184 cases in each group. All underwent COH. Those in the treated group received assist therapy of CMHSTBNA from the menstrual period day 2 -3 of COH to the day of oocytes retrieved. The serum hormone level [including estrogen (E2), progesterone(P), luteal hormone (LH) on the day of human chorionic gonadotrophin (hCG) administration], the medication days and dosage of gonadotropin (Gn), the number of oocytes retrieved, the fertilization rate, and the good-quality embryo rate were observed and compared with the control group. RESULTS: The endometrial thickness on the day of oocytes retrieved was 10.85 +/- 1.63 mm in the treated group, larger than that in the control group (10.50 +/- 1.49 mm) (P <0.05). The good-quality embryo rate and the frozen rate were 48. 9% and 39. 7% respectively in the treated group, superior to those of the control group (45. 4% and 35. 8% respectively), showing statistical difference (P < 0.05). On the day of hCG administration, favorable tendency was shown in the serum levels of estradial (E2), progesterone (P), luteinizing hormone (LH), the medication days and dosage of Gn, the number of oocytes retrieved, the fertilization rate, and the cleavage rate, showing no statistical difference when compared with the control group (P >0.05). CONCLUSION: The combined application of CMHSTBNA and gonado-trophic hormones in COH cycle could elevate the embryo quality, improve the endometrial state, thus laying foundation for successful in vitro fertilization/intracytoplasmic sperm embryo transfer.