To observe the clinical efficacy of Tiaojing Cuyun Formula in treating infertility due to kidney deficiency type polycystic ovary syndrome(PCOS) complicated by sleep disorders.Methods:A total of 98 PCOS infertility patients visited the gynecology outpatient department of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated with Shanghai University of Traditional Chinese Medicine from October 2021 to November 2022 were enrolled and randomly divided into an observation group and a control group using a random number table,with 9 dropouts,resulting in 45 patients in the observation group and 44 in the control group.The observation group received Tiaojing Cuyun Formula,while the control group was treated with Letrozole.Both groups began treatment on the fifth day of their menstrual cycle and were treated for three menstrual cycles,with follow-up until 8 weeks of pregnancy for those who conceived.The pregnancy rate,dominant follicle ovulation rate,luteinization rate,endometrial thickness during ovulation,baseline hormone levels,Pittsburgh Sleep Quality Index(PSQI) scores,and traditional Chinese medicine(TCM) syndrome scores were compared between the two groups.Results:There was no significant difference in the overall pregnancy rate(37.78% vs.25%,P>0.05) and clinical pregnancy rate(88.24% vs.54.55%,P>0.05) between the two groups.The dominant follicle ovulation rate also showed no significant difference(57.48% vs.65.89%,P>0.05).The luteinization rate in the observation group was lower than that in the control group(8.66% vs.17.83%,P<0.05).The increase in endometrial thickness during ovulation in the observation group was superior to that in the control group(P<0.05).After treatment,the levels of luteinizing hormone(LH),LH/follicle-stimulating hormone(FSH) ratio,and testosterone(T) in the observation group decreased to a lesser extent than the control group(P<0.05).The PSQI scores and TCM syndrome scores in the observation group were both lower than those in the control group after treatment(P<0.05).Conclusion:Tiaojing Cuyun Formula can effectively treat kidney deficiency type PCOS infertility,improve pregnancy and dominant follicle ovulation rates,reduce luteinization rates,increase endometrial thickness during ovulation,and lower baseline LH,LH/FSH ratio,and T levels.Additionally,this formula can enhance sleep quality and alleviate clinical symptoms of kidney deficiency in PCOS infertility patients,thereby improving quality of life.