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1、ORIGINAL ARTICLEThe ESHREESGE consensus on the classification of femalegenital tract congenital anomaliesGrigoris F.Grimbizis&Stephan Gordts&Attilio Di Spiezio Sardo&Sara Brucker&Carlo De Angelis&Marco Gergolet&Tin-Chiu Li&Vasilios Tanos&Hans Brlmann&Luca Gianaroli&Rudi CampoReceived:14 March 2013/A
2、ccepted:8 April 2013/Published online:13 June 2013#The Author(s)2013.This article is published with open access at SAbstract The new ESHRE/ESGE classification system offemale genital anomalies is presented,aiming to provide amore suitable classification system for the accurate,clear,correlated with
3、clinical management and simple categoriza-tion of female genital anomalies.Congenital malformationsof the female genital tract are common miscellaneous de-viations from normal anatomy with health and reproductiveconsequences.Until now,three systems have been proposedfor their categorization,but all
4、of them are associated withserious limitations.The European Society of HumanReproduction and Embryology(ESHRE)and the EuropeanSociety for Gynaecological Endoscopy(ESGE)haveestablished a common Working Group,under the nameCONUTA(CONgenital UTerine Anomalies),with the goalof developing a new updated c
5、lassification system.A scien-tific committee has been appointed to run the project,lookingalso for consensus within the scientists working in the field.The new system is designed and developed based on:(1)scientific research through critical review of current proposalsand preparation of an initial p
6、roposal for discussion betweenthe experts,(2)consensus measurement among the expertsthrough the use of the DELPHI procedure and(3)consensusdevelopment by the scientific committee,taking into accountthe results of the DELPHI procedure and the comments of theexperts.Almost 90 participants took part in
7、 the process ofdevelopment of the ESHRE/ESGE classification system,con-tributing with their structured answers and comments.TheESHRE/ESGE classification system is based on anatomy.Anomaliesareclassifiedintothefollowingmainclasses,express-inguterineanatomicaldeviationsderivingfromthesameembry-ologica
8、l origin:U0,normal uterus;U1,dysmorphic uterus;U2,septate uterus;U3,bicorporeal uterus;U4,hemi-uterus;U5,aplasticuterus;U6,forstillunclassifiedcases.Mainclasseshavebeen divided into sub-classes expressing anatomical varietieswith clinical significance.Cervical and vaginal anomalies areclassified ind
9、ependently into sub-classes having clinical signifi-cance.TheESHRE/ESGEclassificationoffemalegenitalanom-alies seems to fulfil the expectations and the needs of the expertsin the field,but its clinical value needs to be proved in everydaypractice.The ESHRE/ESGE classification system of femalegenital
10、 anomalies could be used as a starting point for thedevelopment of guidelines for their diagnosis and treatment.Keywords ESHRE.ESGE.Femalegenitaltractcongenitalanomalies.ESHRE/ESGEclassificationsystem.DELPHIprocedureIntroductionCongenital malformations of the female genital tract aredefined as devia
11、tions from normal anatomy resulting fromembryological maldevelopment of the Mllerian orparamesonephric ducts.They represent a rather commonbenign condition with a prevalence of 4 to 7%7,13,26.ESHRE pages content is not externally peer-reviewed.The manuscripthas been approved by the Executive committ
12、ee of ESHRE.This manuscript is being published simultaneously in the journals ofHuman Reproduction and Gynecological Surgery.G.F.Grimbizis:S.Gordts:A.Di Spiezio Sardo:S.Brucker:C.De Angelis:M.Gergolet:T.-C.Li:V.Tanos:H.Brlmann:L.Gianaroli:R.CampoCongenital Uterine Anomalies(CONUTA)commonESHRE-ESGEWo
13、rking Group,ESGE Central Office,Diestsevest 43/0001,3000,Leuven,BelgiumG.F.Grimbizis(*)First Department of Obstetrics&Gynecology,Aristotle University of Thessaloniki,Tsimiski 51 Street,54623,Thessaloniki,Greecee-mail:grimbimed.auth.grG.F.Grimbizise-mail:Gynecol Surg(2013)10:199212DOI 10.1007/s10397-
14、013-0800-xMoreover,dependingonthetypeandthedegreeofanatomicaldistortion,they are associated with health and reproductiveproblems 5,8,10,12,13,16,18,20,25,27.Due to theirprevalenceand clinicalimportance,a reliable classificationsystem seems to be extremely useful for their management;effective catego
15、rization enables more effective diagnosisand treatment as well as a better understanding of theirpathogenesis 14.Until now,three systems have been proposed for theclassification of female genital tract anomalies,althoughhistorically attempts for their categorization started quiteearlier 2,14:the Ame
16、rican Fertility Societys(AFS)currently American Society of Reproductive Medicine sys-tem 3,6,the embryologicalclinical classification systemof genito-urinary malformations 1,2 and the Vagina,Cervix,Uterus,Adnexae and associated Malformationssystem based on the Tumor,Nodes,Metastases principlein onco
17、logy 21.Although each proposal does not have the same accep-tance,with that of the AFS classification system to be higherthan the others,all of them seem to be associated with seriouslimitations in terms of effective categorization of the anoma-lies,clinical usefulness,simplicity and friendliness 14
18、.It isnoteworthy to mention that these limitations also originatedfurther subdivisions for certain categories of anomalies 9,17,18,24,25,27,30.A systematic re-evaluation of the currentproposals,within a project of the European Academy forGynecological Surgery(EAGS),has been already publishedunderlyi
19、ng the need for a new and updated clinical classifica-tion system 14.The European Society of Human Reproduction andEmbryology(ESHRE)and the European Society forGynaecological Endoscopy(ESGE),recognizing the clinicalsignificance of female genital anomalies,have established acommon working group under
20、 the name CONUTA(CONgenital UTerine Anomalies),with the goal of develop-ing a new updated classification system.For this purpose,ascientific committee has been appointed to run the project,looking alsofor consensus withinthe scientistsworking inthefield through the use of DELPHI procedure 11,14,19.T
21、he ESHRE/ESGE classification system of female genitalanomalies is presented in this paper.It is designed havingmainly clinical orientation and being based on the anatomyof the female genital tract.Strategy for the development of the new systemThe development of the new ESHRE/ESGE classificationsyste
22、m by the CONUTA ESHRE/ESGE Working groupincluded the following steps(Fig.1):(1)scientific workfor the preparation of the questionnaires,the design of thenew system and the preparation of an initial proposal fordiscussion among the experts in the field,(2)consensus mea-surement through the use of the
23、 DELPHI procedure to assessthe extent of agreement of the experts and to have their com-mentsforthedevelopmentofthenewsystemand(3)consensusdevelopment through the incorporation of the results of theDELPHI procedure and of the comments of the experts bythe scientific committee into the final classifi
24、cation system.Scientific work for the design of the new systemScientific work was necessary for the evidence-based devel-opment of the new classification system;it was also aprerequisite for the design of the structured questionnairesfor the DELPHI procedure.The scientific work had two distinct part
25、s;(1)As firstpart,a systematic re-evaluation of the current proposalshas been done and,based on their criticism,the charac-teristics of the new classification system have been clar-ified 14.This work was run as a project of the EAGS,and it was later adopted by the Scientific Committee ofthe CONUTA g
26、roup.This document has been used asthe scientific basis for the design of the structured ques-tionnaire for the DELPHI procedure.(2)The second partwas the preparation of a proposal for the new updatedclinical classification of female genital anomalies to beused during the DELPHI procedure to rank th
27、e agree-ment of the experts and to have their comments beforedeciding the final classification system.The proposal of theSC for the classification of uterine anomalies has onlybeen published just before the second round of the DELPHIprocedure 15 in order to have the blind answers of theexperts durin
28、g round one.DELPHI procedure for consensus assessmentDELPHI procedure is a well-known consensus methodenabling to derive quantitative estimates through qualitativeapproaches.It aims to rank the agreement on a scientific issuewithconflicting evidence,the extent towhich each participantagrees with the
29、 issue under consideration and the extent towhich the responders agree with each other 11,19,31.The DEPLHI procedure for the development of the newclassification system has been designed and processed intotwo rounds as follows:Preparation phase1.Preparation of the structured questionnairesThe SC,bas
30、ed on the scientific work previously de-scribed,has designed for the first round of the DELPHIprocedure a structured questionnaire aiming to have theopinion of the participants on the need and the desiredcharacteristics of a new classification system.For this200Gynecol Surg(2013)10:199212reason,ques
31、tions have been grouped under a limitednumber of headings and statements drafted for circulationto all participants(Table 1).Furthermore,there was asection for comments.For the second round,the ques-tionnaire has been changed aiming to assess the agree-mentoftheparticipantswiththenewproposalandtohav
32、etheir comments on it(Table 2).It should be noted that in the same questionnaire therewere parts aiming to assess the opinion of the participantsfor the existing classification systems(their advantagesandtheirlimitations)andtohavetheircommentsonthem;the results on this issue will be presented in ano
33、therdocument.The agreement rate for each statement was calculatedas follows:no.of participants who agreeno.of partic-ipants who disagree/no.of participants(agree+indiffer-ent+disagree);agreement rates 67%are considered asconsensus for agreement and 50%of the uterine wall thickness.Anew subcategory u
34、nder the general term“others”wasadded in class I/dysmorphic uterus,giving the opportuni-ty to include all minor deformities of endometrial cavityincluding midline indentations less than 50%of theuterine wall thickness;the clinical value of this variantneeds further clinical research.Thus,definition
35、of classesand especially those of septate uterus remained clear.There were some comments regarding the subcategoriesof cervical and vaginal anomalies.A proposal to includepartial vaginal agenesis as a different subcategory hasnot been adopted since it does not seem to be of anyclinical value.The ter
36、m(cervical/vaginal)dysplasia wasdeleted from the classification since it is generally usedfor intraepithelial neoplasia.Thus,the subcategoriesremained as in the initial proposal.The simplicity of the new system has been discussed.Itwas pointed out that for the vast majority of anomalies,only the use
37、 of uterine categories was necessary,whilecervical and vaginal ones were not.In conclusion,the ESHRE/ESGE classification systemwas the final result of a process including scientific research,consensus assessment and consensus development.The ESHRE/ESGE classification systemDesign of the new system:m
38、ain conceptsThe ESHRE/ESGE classification system is presented inFigs.2 and 3.It has the following general characteristics:1.Anatomy is the basis for the systematic categorizationof anomalies2.Deviations of uterine anatomy deriving from the sameembryological origin is the basis for the design of them
39、ain classes3.Anatomical variations of the main classes expressingdifferent degrees of uterine deformity and being clini-cally significant are the basis for the design of the mainsub-classes4.Cervical and vaginal anomalies are classified in inde-pendent supplementary subclasses.Anomalies are sorted i
40、n the classes and subclasses of thesystem according to increasing severity of the anatomicaldeviation;the less severe variants are placed in the begin-ning,the more deformed types at the end.For sake ofsimplicity,an extremely detailed sub-classification isavoided:anatomical variations of uterine,cer
41、vical andvaginal anomalies are grouped in subclasses having ascriterion the clinical significance of the abnormality.DefinitionsUterine main classes and sub-classes&Class U0 incorporates all cases with normal uterus.Anormal uterus is any uterus having either straight orcurved interostial line but wi
42、th an internal indentationat the fundal midline not exceeding 50%of the uterinewall thickness.The use of absolute numbers(e.g.inden-tation of 5 mm)is avoided in definitions as uterinedimensions as well as uterine wall thickness could nor-mally vary from one patient to another.Thus,it wasdecided to d
43、efine uterine deformity as proportions ofuterine anatomical landmarks(e.g.uterine wall thick-ness).The addition of normal uterus gives the opportu-nity to independently classify congenital malformationsof the cervix and vagina 16,25,27.&Class U1 or Dysmorphic uterus incorporates all caseswith normal
44、 uterine outline but with an abnormal shapeof the uterine cavity excluding septa.Class I is furthersubdivided into three categories;Class U1a or T-shaped uterus characterized by anarrow uterine cavity due to thickened lateral wallswith a correlation 2/3 uterine corpus and 1/3 cervix,Class U1b or ute
45、rus infantilis characterized also by anarrowuterinecavitywithoutlateralwallthickeningandaninverse correlationof 1/3uterine bodyand2/3cervixClass U1c or others which is added to include allminor deformities of the uterine cavity includingthose with an inner indentation at the fundal midlinelevel of l
46、ess than 50%of the uterine wall thickness.This aims to facilitate groups who want to studypatients with minor deformities and to clearly differ-entiatethemfrompatientswithseptateuterus12,29.Usually,dysmorphic uteri are smaller in size.&Class U2 or septate uterus incorporates all cases withnormal fus
47、ion and abnormal absorption of the midlineseptum.Septate is defined as the uterus with normaloutline and an internal indentation at the fundal midlineexceeding 50%of the uterine wall thickness.Thisindentation is characterized as septum and it could di-vides partly or completely the uterine cavity in
48、cluding insome cases cervix and/or vagina(see cervical and vag-inal anomalies).Gynecol Surg(2013)10:199212207Class U2 is further divided into two sub-classesaccording to the degree of the uterine corpus deformity:Class U2a or partial septate uterus characterized bythe existence of a septum dividing
49、partly the uterinecavity above the level of the internal cervical osClass U2b or complete septate uterus characterizedby the existence of a septum fully dividing the uterinecavityuptotheleveloftheinternalcervicalos.Patientswith complete septate uterus(class U2b)could have ornot cervical(e.g.bicervic
50、al septate uterus)and/or vag-inal defects(see cervical/vaginal anomalies)14.&Class U3 or bicorporeal uterus incorporates all casesoffusiondefects.As bicorporeal isdefined the uteruswithan abnormal fundal outline;it is characterized by thepresence of an external indentation at the fundal midlineexcee