జర్నల్ ఆఫ్ క్లినికల్ ట్రయల్స్
అందరికి ప్రవేశం

నైరూప్య

Impact of the Combined Application of DE T-1 and Sho-ko-sen on the Outcomes of Assisted Reproductive Treatment in Refractory Infertile Populations: A Retrospective Study

Hui Shao*, Jianli Ren, Xi Dong, Lin Wang，Shuang Jiao, Nobuyuki Yanagihara, Shoji Kokeguchi, Masahide Shiotani

Objective: To observe the influence factors of assisted reproductive treatment outcomes and the impact of the combined application of DE T-1 (Shawkea T-1) and Sho-ko-sen (Songkangquan) of refractory infertility patients.

Methods: A retrospective study was conducted. 31 patients defined as refractory infertility who had embryo transfer at least one time with the pregnancy test positive at Hanabusa Women’s Clinic of Japan from January 2016 to October 2019 were enrolled in this study. All the enrolled patients took DE T-1 oral solution and Sho-ko-sen capsule according to the nutritional support center's recommendations at Hanabusa Hospital. The general information of the patients was recorded, and In Vitro Fertilization (IVF) treatment process was recorded and the usage of the DE T-1 and Sho-ko-sen was analyzed.

Results: The patients enrolled were aged from 30 to 48 years, with a median (P25, P75) age of 36.0 (34.0, 39.0) years. AMH ranged from 0.4 ng/ml to 17.9 ng/ml, with a median (P25, P75) of 1.74 (0.80, 3.90) ng/ml. The duration of infertility ranged from 3 to 12 years, with a median (P25, P75) of 6.0 (5.0, 9.0) years. All 31 patients gave live births, including 29 cases (93.5%) with single births and 2 cases (6.5%) with twins. A total of 72 egg retrieval cycles were performed in the 31 patients, including 5 cases (6.5%) of long protocol, 7 cases (9.7%) of short protocol, 12 cases (16.7%) of antagonist protocol, and 48 cases (66.7%) of micro-stimulation protocol. Among the 31 patients included, 7 cases (22.6%) underwent one egg retrieval cycle, 16 cases (51.6%) underwent two cycles. A total of 38 embryo transplantation cycles were performed in the 31 patients, including 24 cases (77.4%) with one transplantation, and 7 cases (22.6%) with two transplantations. Among the 38 transplantation cycles, 36 (94.7%) used the Stimulation of Endometrium-Embryo Transfer (SEET) method and 2 (6.3%) used the two-stage method. Among the enrolled patients, 10 cases (32.3%) took 3 bags of DE T-1 and 6 capsules of Sho-ko-sen; 18 cases (58.1%) took 4 bags of DE T-1 and 6 capsules of Sho-ko-sen; and 3 cases (9.7%) took 5 bags of DE T-1 and 9 capsules of Sho-ko-sen. The duration of DE T-1 and Sho-ko-sen usage ranged from 4 to 45 months, with a median (P25, P75) duration of 10 (7, 14) months.

Conclusion: Under the premise of standardized IVF treatment, taking DE T-1 and Sho-ko-sen according to standardized courses and doses might help patients with refractory infertility achieve satisfactory treatment results, and mild stimulation would be the most suitable method for oocyte retrieval.