Objective

2

To evaluate the effect of Wenshen Yangxue prescription （WSYX） on the outcome of

in vitro

fertilization-embryo transfer （IVF-ET） in poor ovarian responders and the safety.

Method

2

A total of 116 eligible patients who were admitted to Beijing Obstetrics and Gynecology Hospital in June 2016-June 2019 were randomized into the experimental group and the control group with random number table method （58 in either group）. Conventional controlled ovarian hyperstimulation （COH） was directly implemented in the control group， while the experimental group was intervened with WSYX for 3 menstrual cycles before the COH. The pregnant patients were observed till childbirth and the non-pregnant patients for 12 months. Gonadotropins （Gn） dosage and the days of use were recorded. Serum levels of follicle-stimulating hormone （FSH）， basal FSH （bFSH）， basal luteinizing hormone （bLH）， and basal estrogen （bE

2

）， endometrial thickness， and antral follicle count （AFC） before and after treatment were measured. The serum levels of estrogen （E

2

）， progesterone （P）， and luteinizing hormone （LH） on the day of human chorionic gonadotropin （HCG） injection， and levels of FSH， LH， E

2

， testosterone （T）， and P in follicular fluid 36 h after HCG injection were determined. Number of fertilization， rate of fertilization， number of high-quality embryos， cycle cancellation rate， clinical pregnancy rate， and live birth rate were evaluated. The traditional Chinese medicine （TCM） syndrome scores before and after treatment were recorded. Liver and kidney functions were detected before and after treatment， and adverse reactions during treatment were recorded.

Result

2

Compared with the control group， the experimental group showed the decrease in the days of Gn use and dosage of Gn （

P

<

0.05）， endometrium thickening （

P

<

0.05）， and increase in oocytes obtained， levels of E

2

and LH on the day of HCG injection， and ovarian reserve function. Moreover， in follicular fluid 36 h after HCG injection， the reduction in level of FSH （

P

<

0.05）， rise of levels of LH and E

2

（

P

<

0.05）， and insignificant changes in levels of T and P in the experimental group were observed as compared with those in the control group. In addition， larger number of fertilization， more available embryos， and higher rate of high-quality embryos were observed in the experimental group than in the control group （

P

<

0.05）. The experimental group demonstrated improvement in quality of oocytes， decrease in cycle cancellation rate ， and increase in clinical pregnancy rate and live birth rate compared with the control group. The TCM syndrome score in experimental group was decreased after treatment compared with that before treatment （

P

<

0.05）. No serious adverse reactions occurred in two groups during treatment and the safety indexes before and after treatment were all within the normal ranges.

Conclusion

2

WSYX can reduce the use duration and dosage of Gn in infertile patients receiving IVF-ET， improve the quality of oocytes， increase the rate of high-quality embryos， and improve the pregnancy outcome of IVF-ET patients.