| Background and ObjectivePolycystic ovary syndrome(PCOS)is a common reproductive endocrine disease,affects 5% to 10% of reproductive-age women and is considered as the most common cause of anovulatory infertility.The risk of miscarriage and pregnancy complications in PCOS patients is increased,which seriously affects the health of patients and their offspring.Therefore,it has become a research focus to find a safe treatment that can improve ovulation rate,pregnancy rate,live birth rate while reduce pregnancy complications.Acupuncture,as an important part of traditional Chinese medicine,has a history of more than 3000 years in China.It has been proved that acupuncture or electroacupuncture can effectively reduce weight,normalize metabolic and ovulation disorders and improve endometrial receptivity,which is expected to become an effective treatment for PCOS infertility patients.The study related to the effect of acupuncture on the live birth rate of PCOS infertile women is very limited so far.In this study,a multicenter randomized controlled trial was designed to investigate the effect and safety of acupuncture pretreatment on the live birth rate,other pregnancy related outcomes and metabolic disorders of PCOS infertile women.MethodIn this multicenter randomized controlled trial,we randomly assigned 384 women aged 20-40 who met the inclusion criteria,in a 1:1 ratio,to receive acupuncture pretreatment + letrozole(treatment group)or letrozole alone(control group).PCOS was defined according to modified Rotterdam criteria(anovulation with either hyperandrogenism or polycystic ovaries).Before the ovulation induction(2.5-7.5 mg per day for 5 days),the subjects in the treatment group need to be treated with acupuncture for 16 weeks(3 times a week,30 minutes each time,with an interval of 1-3 days,48 times in total).The control group was treated with letrozole alone without acupuncture.Letrozole was used for up to four treatment cycles in both groups.All subjects and their husbands were required to have regular intercourse with the intent of conception during the ovulation induction period.The primary outcome was live birth rate and secondary outcomes included conception rate,pregnancy rate,pregnancy loss rate,ovulation rate,pregnancy complications,adverse events and other glucose and lipid metabolism parameters during the treatment period.Results1.Baseline characteristics: the mean(SD)age of the treatment group was 28.2(3.4)years,the mean(SD)BMI was 22.3(3.5),and the mean(SD)duration of infertility was 20.9(16.7)months.Among them,178(178/192,92.7%)subjects completed acupuncture treatment,171(171/192,89.1%)completed ovulation induction cycles and follow-up.In the control group,the mean(SD)age was 27.9(3.5)years,the mean(SD)BMI was 23.3(3.6),and the mean(SD)duration of infertility was 23.6(17.6)months.161(161/192,83.9%)completed ovulation induction cycles and follow-up.The total dropout rate was 27.1%(52/192).2.Primary outcome: Compared to letrozole alone,women who received acupuncture pretreatment followed by letrozole could increase the cumulative live rate by 6.8%,but there was no significant difference between groups(79/192 [41.1%]vs.66/192 [34.4%],P>0.05).Treatment group was related to higher live birth rate than control group in the first cycle(36/192 [18.8%] vs.21/192 [10.9%],P=0.044;rate ratio,1.7;95% confidence interval,1.0 to 2.8).3.Secondary outcomes: the subjects in treatment group were associated with higher conception rate than those in control group(55.7% vs.44.3%,P=0.032).There was no significant difference in pregnancy rate(43.8% vs.36.5%,P>0.05),pregnancy loss rate(26.2% vs.22.4%,P>0.05),ovulation rate(75.7% vs.71.4%,P>0.05)and pregnancy complications between groups.In addition,compared with the control group,BMI(P=0.021),total cholesterol(P=0.049)and apolipoprotein B(P=0.015)were significantly reduced in the treatment group.One case of neonatal death was reported in the control group,but there was no significant difference in serious adverse events or adverse events between groups.ConclusionAmong infertile women with PCOS,compared with letrozole alone,acupuncture pretreatment followed by letrozole:1.could increase the cumulative live rate by 6.8%,but the difference was not statistically significant.2.could significantly increase the first cycle live birth rate,and it was associated with higher pregnancy rate.3.had no significant improvement on pregnancy complications.4.could reduce body mass index and improve lipid metabolism.5.acupuncture is a relatively safe treatment for PCOS infertility. |
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