Clinical Phenotype Of Patients With PCOS Between North And South And The Adberse Events About PCOSAct Project

Objective:This literature analyses the clinical phenotype o f the 1000 subjects who were enrolled within PCOSAct between South and North.Furthermore,according to international report on infertility clinical trials-Harbin consensus,we should pay attention to the collection of adverse events,including the adve rse event of the subject,subject’s husband and the neonate,by studying a multicenter,large-sample,double-blinded acupunctur e clinical trial(PCOSAct,Polycystic Ovary Syndrome Acupunctur e Clinical Trial),this literature discusses the stragety of collect ing adverse events based on international report on infertility cl ini cal trials-Harbin consensus,and reports severe adverse events,and underscores the importance and neccessity of collecting ad verse events to infertility clinical trials,which can provide a re ferrence to collecting of adverse events in future infertility clin ical trials.Method:1.Analysis of the baseline characteristics of PCOS in South and North:(1)Physical examination index(height,weight,BMI,WHR and so on);(2)Vital signs indicator(pulse,respiration and so on);(3)Transvaginal ultrasound results(uterus shape,endometrial thickness,left and right ovary volume,antral follicle count and so on);(4)Laboratory examination(progesterone,total te st oster one,LH,FSH,glucose,triglyceride,high-density lipoprotein,low-density lipoprotein and so on);(5)Questionnaire about subject(PCOSQOL,SAS,SDS and so on);(6)Past medical history(general history,family history,life style,history of treatments and so on).2.Analysis of adverse event:According to the introduction of the importance of adverse event,colleciton stragety,weakness and improvement,to evaluate the safety of the interventions of this project.3.Analysis of severe adverse event:To report every sever adverse event in this project and underline the importance of reporting severe adverse event in clinical trials.Result:1.Comparison of baseline characteristics of PCOS in the South and North:(1)Physical examination index:The height,weight,BMI,waist circumference,hip circumference,and WHR of northern PCOS subjects are higher than or greater than that of the southern PCOS subjects(P<0.05);36%PCOS subject had acne in North,29%in the South,they had significant difference;the score about hirsutism and acanthosis nigricans of northern subjects were higher than that of southern subjects(P<0.05).There were no differences in subject,s age and husband,s age between North and South.(2)Vital signs indicator:The systolic pressure,diastolic pressure and mean arterial pressure of northern subjects were higher than that of southern subjects(P<0.05);there were no difference in pulse pressure,pulse and breath between northern and southern subjects(P>0.05).(3)Transvaginal ultrasound results:The uterine volume of northe rn subjects was greater than that of southern subjects(P<0.05);there were no differences in uterine morphology,uterine endom etrial thickness,uterine fibroids,ovarian volume,ovarian cyst,a nd antral follicle number between northern and southern subjects(P>0.05).(4)Laboratory examination:①The free testosterone and insulin level of northern subjects were higher than that of the southern subjects,while the serum SHBG level was lower than that of southern subjects;the serum LH,LH/FSH and E2 of northern subjects were higher than that of the northern subjects(P<0.05);there were no difference in serum P,FSH and testosterone between northern and southern subjects(P>0.05).②There was no difference in serum FAI and HOMA-IR between the northern and southern subjects(P>0.05);the serum INS and GLU levels of northern subjects were higher than that of southern subjects(P<0.05).③The serum TG,HDL and APOB of northern subjects were higher than that of southern subjects,and APOA on the contrary,the differences were statistically significant(P<0.05);there were no difference in serum LDL,CHO and LP between northern and southern subjects(P>0.05);the serum cystatin C,homocysteine and lactic acid dehydrogenase of northern subjects were higher than that of southern subjects.④The serum total bile acid of southern subjects was higher than that of northern subjects(P<0.05);there were no difference in serum total bilirubin,direct bilirubin,indirect bilirubin,creatinine,urea,GPT and GOT between northern and southern subjects(P>0.05).⑤There were no differences in serum phosphorus and potassium levels between northern and southern subjects(P>0.05);but ther e were differences in the serum calcium,sodium,magnesium and chloride level between northern and southern subjects(P<0.05).(5)Questionnaire about subjects:①The life quality of patients with PCOS were affected by infertility,body mass,emotional problems,menstrual problems and body hair;there was no difference in body hair,infertility,menstrual status between northern and southern subjects(P>0.05);the emotional scores of northern subjects were greater than that of southern subjects(P<0.05);the weight scores of southern subjects were higher than that of northern subjects(P<0.05).②16%subjects with PCOS had anxiety phenomenon,its SAS scores were greater than 50.The SAS scores of southern subjects(19%)were greater than that of northern subjects(14%)(P>0.05).③9%of PCOS subjects had mild depression,5%severe depression,1%severe depression,there was no differences in depression between northern and southern subjects(P>0.05).④There was no difference about CHQOL between northern and southern subjects(P>0.05).⑤The score about SF-36 of northern subjects was higher than that of sorthern subjects(P<0.05).(6)Past medical history:①There were no difference in thyroid disease between northern and southern subjects(P>0.05);but the incidence of fatty liver of northern subjects was higher than that of the southern subjects(P<0.05).②There were no difference in prior pregnancy,prior spontaneous abortion,prior induced abortion,prior premature birth,prior ectopic pregnancy,length of time subject had been attempting conception,sperm concentration between northern and southern(P>0.05);but there are differences in prior premature and prior full-term birth(P<0.05),the incidence of southern subjects was higher than that of northern subjects.③There were no difference in maternal and paternal family hist ory(Diabetes,menstruation or amenorrhea,premature baldness)(P>0.05);but there are differences in genital tumors and hypert ension(P<0.05).④The exercise time of northern subjects was less than that of s outhern subjects(P<0.05);in China,4%patients with PCOS smo ked in the past,29%patients with PCOS drinked in the past;54%the husband of subjects smoked in the past,65%the husban d of subjects drinked in the past.⑤There was no difference in diagnosed infertility,accept drug for infertility,received treatment for surgical and assisted reproductive technology,ovulation by using CC,received acupuncture treatment for regulating menstruation between the northern and southern subjects(P>0.05).32%subjects had taken contraceptive measures in South,and 23%in North;there were difference in taking CC for infertility and PCOS(P<0.05),the south was 32%,the North was 25%;71%subjects had taken drug for regulating menstrual cycle,and 64%in South,there was difference(P<0.05).2.Adverse event:(1)more than 900 adverse evetns of patients occured during infertilit intervention,more than 80 of them were related to acupunture,more than 800 of them were not related to acupuncture.(2)3 adverse events of husbands occured during infertility intervention.(3)more than 600 adverse events of patients occured during pregnacy.(4)8 adverse events of patients during delivery and postpartum.(5)almost 40 adaverse events occured on infants after 20 weeks and neonates.3.Severe adverse event:more than 70 severe adverse events occured during this project:three during infertility interventions,more than 50 during pregnancy,twelve with infants after 20 weeks and neonates.Conclusion:1.Baseline characteristics of the subjects in the North and South:(1)The height,weight,BMI,waist circumference,hip circum ference,WHR of subjects with PCOS in North are higher or grea ter than that of subjects in South.(2)The blood pressure of sub jects in North was higher than that of subjects in South.(3)Ther e were differences in acne,hirsutism,acanthosis nigricans,uteri ne volume between northern and southern subjects.(4)Laboratory examination:There were differences in serum sex hormones,ser um electrolytes,indicators related glucose and lipid metabolism between southern and northern areas.(5)Questionn a ire:Infertility was the main factor which affected the quality of life for patie nts with PCOS in China;patients with PCOS had anxiety and d epression;the quality of life of patients with PCOS in South w as lower than that of patients in North.(6)Past medical history:T here were difference in fatty liver,genital cancers,exercise time,contraception,hi story of taking medicine between northern and southern region.2.The collection of adverse events in this project is compre hensive and can be seen as an good example to future clinical trials.3.The severe adverse events in this project were recorded completely and detailedly which were irrelevant with infertilit interventions.