Hysteroscopic Hydrosalpinx Occlusion With Essure Device in IVF Atients When Salpingectomy or...

8/19/2019 Hysteroscopic Hydrosalpinx Occlusion With Essure Device in IVF Atients When Salpingectomy or Laparoscopy is Co…

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Hysteroscopic hydrosalpinx occlusion with Essure device inIVF atients when salpingectomy or laparoscopy iscontraindicatedA B S T R A T

!"#ective$ To evaluate% in patients with hydrosalpinges% the e&ect on in vitro 'ertili(ation )IVF* outcomeo' the insertion "y hysteroscopy o' an intratu"al "loc+ing device% in cases where laparoscopic

salpingectomy or laparoscopy was contraindicated,Study design$ A prospective interventional case series study was conducted in -'teen women withunilateral ). / 0* or "ilateral hydrosalpinges ). / 1* su"mitted 'or IVF, In all o' them% laparoscopicsalpingectomy was contraindicated, Hysteroscopic insertion o' the Essure intratu"al device in aconsultation room setting was per'ormed, IVF results were compared with those o' women wherehydrosalpinx was treated "y laparoscopic salpingectomy )23 women% 40 cycles*,Results$ There were no complications during or immediately a'ter the procedure in any o' the patients, There were 'our pregnancies 'rom 50 em"ryo6trans'ers with own oocytes% one spontaneous pregnancya'ter unilateral Essure insertion% and one pregnancy a'ter oocyte donation, In one case the hydrosalpinxgrew and pelvic in7ammatory disease developed 0 months a'ter the insertion% re8uiring "ilateraladnexectomy, Although not o' statistical signi-cance% IVF pregnancy rates were somewhat lower than inthe laparoscopic salpingectomy group% which was attri"uted to the lower ovarian reserve "e'ore Essureinsertion,onclusion$ The hysteroscopic insertion o' the Essure intratu"al device prior to IVF is a reasona"le optionin cases where laparoscopic salpingectomy is contraindicated, 9arger series are re8uired to assesspregnancy outcome,

5, IntroductionIn tu"al 'actor in'ertility due to "ilateral hydrosalpinx% in vitro

'ertili(ation )IVF* is the -rst option rather than attempting torestore tu"al 'unction :5;, The hydrosalpinges% however% adverselya&ect IVF outcomes% reducing the implantation rate and increasingthe ris+ o' miscarriage :<%=;, A num"er o' underlying pathogenicmechanisms have "een proposed$ em"ryotoxic e&ects% mechanical7ushing and changes in endometrial receptivity :5%2;, Since thehydrosalpinx 7uid is in 'ree communication with the uterinecavity% any surgical intervention interrupting this communicationcould improve the pregnancy rates :5%>%0;, 9aparoscopic salpingectomyhas "een demonstrated to "e an e&ective option and has the advantages o' removing the ris+ o' pelvicin7ammatory diseaseand ectopic pregnancies and o' improving the accessi"ility o' ovarian tissue, It has draw"ac+s% however% including the invasiveness%potential ris+s o' surgical in#ury and anesthesia% and technicaldi?culty in the case o' adhesions :5;, @iven this% a num"er o' alternative options have "een proposed such as laparoscopic

proximal tu"al occlusion :0;% ultrasound6guided hydrosalpinxaspiration :4;% and Essure insertion :355;, The Essure device induces a "enign local -"rous tissue responsethat results in occlusion o' the tu"al lumen and encapsulation o' thedevice :5<;% and it is now widely used 'or tu"al sterili(ation, RecentlyEssure insertion has "een proposed as a sa'e% e&ective and minimallyinvasive alternative to salpingectomy in IVF patients with hydrosalpinges%especially when laparoscopic treatment is contraindicated%'or example in cases with severe o"esity% massive adhesions oranesthesic ris+ :3%55%5=5>;, IVF outcome a'ter Essure occlusion o' the hydrosalpinx has "een reported to "e similar to the generalpopulation :1; or lower :5>;% although in none o' the studies was acontrol group presented% nor were IVF data presented in detail, The aim o' this wor+ is to report ourexperience with the Essuredevice in IVF patients with hydrosalpinx where laparoscopicsalpingectomy was contraindicated% and to compare IVF results

with those o"tained in patients where hydrosalpinx was treated "ylaparoscopic salpingectomy,<, aterials and methods The population under study consisted o' 5> consecutive womenre'erred 'or IVF at our Reproduction Cnit in whom an Essure device)onceptus Inc,% ountain View% A* was inserted to occlude ahydrosalpinx prior to IVF "etween <DD> and <D5D, Throughout thatperiod% the -rst6line therapy in cases where IVF was indicated anda hydrosalpinx was 'ound was laparoscopic salpingectomy "e'orethe IVF, uring the same period% 23 women underwent laparoscopicsalpingectomy )salpingectomy groupGG* and this populationis used as a control group, A second comparison group wasesta"lished including all the women with tu"al 'actor in'ertilityundergoing IVF )n / <02* in the same period% in whom hydrosalpinxhad not "een detected in the systematic pre6IVFexamination )tu"al 'actor without hydrosalpinx groupGG*,

All the IVF cycles reported in the three populations involvedwomen under 2D years o' age% undergoing IVF using their own'resh oocytes, However% data concerning oocyte donation )!*



cycles in the study population carried out in other centers are alsoreported, The in'ertility wor+6up o' our patients "e'ore IVF includedsperm analysis% measurement o' day = hormone levels% vaginalultrasound and hysterosalpingography )HS@* )except in severemale 'actor cases in which ISI was re8uired*, Tu"al 'actorin'ertility was de-ned as the lac+ o' tu"al patency evidenced "yHS@ andor laparoscopy% and hydrosalpinx as a distally occluded

tu"e that was pathologically dilated at HS@ or laparoscopy, Since atthe HS@ an image consistent with hydrosalpinx could correspondto a true hydrosalpinx% or to a distally o"structed tu"e that"ecomes dilated on the in#ection o' radiographic contrast medium%hydrosalpinx diagnosis in the present study was con-rmed "yanother complementary test )ultrasound and% i' possi"le% laparoscopy*,Vaginal ultrasound was used in all cases% with a hydrosalpinx"eing diagnosed when an elongated mass with incompleteseptum was o"served, In the a"sence o' contraindication%laparoscopy was per'ormed to con-rm the presence o' hydrosalpinges%and a&ected tu"es were surgically removed i' technically'easi"le, In cases where laparoscopic salpingectomy or evenlaparoscopy was contraindicated "ecause o' surgical ris+% Essureinsertion was o&ered to the patients,In all cases there was a previous history o' surgery% reportingextensive pelvic adhesions )= patients had laparotomy surgery and

another = had "een operated on twice*, The hysteroscopic placement o' the Essure microinsert wasper'ormed in consultation rooms, Institutional "oard approval andin'ormed consent were o"tained, .o anesthetics were administered%except 'or one case in which a paracervical "loc+ wasneeded, The insertion was per'ormed "y hysteroscopists veryexperienced in carrying out the procedure 'or tu"al sterili(ation,ia(epam )5D mg* and i"upro'en )0DD mg* were given =D min"e'ore the insertion, Transvaginal ultrasound scans )n / =* or HS@)n / 5<* were per'ormed three months a'ter the procedure toevaluate whether the microinsert had "een placed success'ully, Inall cases the Essure was 'ound to "e ade8uately placed, In all caseswhere HS@ was per'ormed% the proximal occlusion o' the tu"e wascon-rmed, The IVF management used has "een previously descri"ed:50%54;, The present study has not received 'unding 'rom themanu'acturer o' the Essure device or any other commercialorgani(ation,For the statistical analysis hi s8uare% FisherGs exact andStudentGs t tests were applied% 'ollowing the standard criteria o' applica"ility, Binary logistic regression models were employed inorder to o"tain ad#usted estimates o' the e&ect o' the type o' tu"alintervention,=, Results The Essure device was inserted while patients were on the IVFwaiting list )range$ =55 months*, In all 5> patients% it was possi"leto carry out the insertion in the consultation room, The duration o' the procedure ranged "etween > and5< min and a mean num"er o' three coils were le't protruding into the uterine cavity )range 52*,All the patients tolerated the procedure well and there were nocomplications during or in the period immediately a'ter theinsertion, Indications 'or Essure insertion were$ extensive intraa"dominaladhesions o' various etiologies$ 1 cases o' pelvicendometriosis% 5 genital tract tu"erculosis and 2 non6tu"erculouspelvic in7ammatory disease )I*% and < massive adhesions o' un+nown etiology, !ne o' the patients with the diagnosis o' massive adhesion syndrome had a "ody mass index o' 2=,In 0 cases the hydrosalpinx was unilateral and in 1 "ilateralJ inunilateral cases devices were inserted only in the a&ected side, In-ve cases% day = FSH levels were K5D mCIm9,!' the 5> patientswho had the device inserted% two are still awaiting IVF, Theremaining 5= are listed in Ta"le 5, There were 0 pregnancies% 'ouro' them resulting 'rom 51 IVF cycles started% corresponding to a<>L pregnancy rate per trans'er )250*, In one additional patient%pregnancy was achieved with the devices inserted "ut a'ter"ilateral adnexectomy% through !, Another woman conceivedspontaneously a'ter unilateral Essure insertion )case 5*, She was a

=56year6old patient with a >6year history o' in'ertility% and "ecamepregnant = months a'ter unilateral insertion o' the Essure, Herindication 'or Essure insertion was 'ro(en pelvis% secondary to I



and unilateral hydrosalpinx, The spontaneous pregnancy was atwin gestation% "ut ended in a miscarriage at the seventh wee+,ase = was re'erred due to stage IV endometriosis and "ilateraltu"al 'actor% with extensive -rm adhesions precluding visuali(ationo' the tu"es, Vaginal ultrasound showed "ilateral hydrosalpinx%and hysteroscopic "loc+age was indicated, Three monthsa'ter the insertion o' the device ovarian stimulation 'or IVF wasstarted% "ut was cancelled "ecause o' a mono'ollicular response

and ! was recommended, She started hormone replacementtherapy in another center, The day "e'ore the em"ryo trans'er o' the -rst ! cycle )six months a'ter the Essure insertion*% she wasadmitted due to severe I, espite pharmacological treatment%emergency surgery was needed and a "ilateral adnexectomy wasper'ormed "y laparotomy without intraoperative complications,Five months a'ter the "ilateral adnexectomy% 'ro(en em"ryotrans'er was per'ormed "ut did not lead to pregnancy, The second! cycle )5> months a'ter Essure insertion* resulted in a singlepregnancy, She was admitted in wee+ =D "ecause o' prematuremem"rane rupture and preterm la"or, A healthy preterm in'antwas delivered "y cesarean section due to "reech presentation,In case 0 a twin pregnancy occurred in the IVF cycle, rematurerupture o' mem"ranes occurred at =5 wee+sG gestation$ at =2 wee+sla"or started% and a cesarean section was per'ormed "ecause o' the"reech presentation o' the -rst 'etus, Two healthy in'ants were

delivered% and there were no postpartum complications,ase 4 was re'erred due to three years o' in'ertility and severepelvic and ureteral endometriosis, A'ter the second oocyteretrieval she was admitted due to a hemoperitoneum attri"utedto ovarian "leeding% and recovered well with expectant management,regnancy was not achieved,ase 1 was a =16year6old patient with two previous unsuccess'ulIVF cycles, 9aparoscopic treatment o' "ilateral hydrosalpinges was contraindicated due to 'ro(en pelvisdiagnosed at previoussurgery, Following the IVF% 55 months a'ter the "ilateral placemento' intratu"al device% a triplet pregnancy occurred, She wasadmitted to an o"stetric ward at =5 wee+s with preterm la"or, The clinical evolution was satis'actory a'ter tocolytic treatment, At =2 wee+s the patient had a cesareandelivery o' three healthyin'ants% and there were no postpartum complications,In case 5D% a right hydrosalpinx was diagnosed during thein'ertility wor+6up, She started her -rst IVF cycle% without success%3 months a'ter the unilateral insertion o' the device, She "ecamepregnant in the second IVF ET cycle "ut had a spontaneousmiscarriage 4 wee+s a'ter em"ryo trans'er,ase 5= "ecame pregnant on the -rst IVF cycle and had a normalpregnancy and a term vaginal delivery induced a'ter thirdtrimester sonographic diagnosis o' meningocele, The in'antunderwent surgery without complications and had no neurologicalse8uelae, Serial ultrasound examinations per'ormed duringpregnancy% starting at the gestational age o' > wee+s% showed nospace con7ict "etween the intratu"al device and the gestationalsac )Fig, 5*,Regarding IVF% the proportion o' cases with higher than normalFSH levels was much greater in the Essure group than in either thesalpingectomyGG )p M D,D>* or non hydrosalpinx tu"al 'actorGGgroups )p M D,D5*% as was the 're8uency o' advanced endometriosis)p M D,D5* ) Ta"les < and =*, Also% the num"er o' oocytes% 'ertili(edoocytes and trans'erred em"ryos o"tained was lower, Althoughthe pregnancy rate was somewhat lower in the Essure group% thedi&erences were not statistically signi-cant ) Ta"le =*,A multivariate analysis was per'ormed concerning -rst IVFcycles% showing that age% "asal FSH K 5D mCIm9 and advancedendometriosis were inversely related to achieving pregnancy% whereas the num"er o' o"tained and'ertili(ed oocytes wasdirectly related to pregnancy, The type o' tu"al surgery )Essure%salpingectomy* was not an independent prognostic 'actor%although the analysis was hampered "y the low num"er o' cases, Nhen logistic regression analysis was applied to assess thee&ect o' the type o' tu"al intervention )Essure or salpingectomy*on the pro"a"ility o' pregnancy% ad#usted 'or the num"er o' retrieved oocytes% the odds ratio o' pregnancy 'or the Essure

method was 5,D3 )I / D,530,25*, Nhen the analysis wasrestricted to cases with 'ewer than 5D oocytes% similar resultswere o"tained$ Essure insertion ) Ta"le =* had an !R o' 5,54



)I / D,544,3>*,2, ommentsHydrosalpinges impair IVF results% presuma"ly due to thedetrimental e&ect o' the hydosalpinx 7uid on implantation :52;,9aparoscopic salpingectomy o' the hydrosalpinx has "een shownto "e a very e&ective way to avoid this pro"lem% and IVF pregnancyrates a'ter this procedure are very similar to those in the generalpopulation :5;, 9aparoscopic salpingectomy% however% involves%

apart 'rom a non6negligi"le cost% undergoing a surgical procedurewith inherent ris+s which are higher in cases with extensive -rmadhesions% as well as in other cases with certain associatedconditions% such as mor"id o"esity, It has also "een suggested thatlaparoscopic salpingectomy could impair the ovarian response togonadotropins :53;, A num"er o' alternative options havethere'ore "een proposed such as laparoscopic proximal tu"alocclusion :0;% ultrasound6guided hydrosalpinx aspiration :4;% andEssure insertion :3%5D%55%51%<D;, The Essure system is "ased on a hysteroscopically placed springemployed as an alternative to laparoscopic tu"al occlusion 'orpermanent sterili(ation, The device itsel' not only is spaceoccupying"ut also incites a local in7ammatory response thatresults in -"rosis o' the tu"al lumen, Insertion o' the device can "ecarried out in an outpatient setting and is well tolerated with no orlocal anaesthesia, oncerning 'easi"ility% in our series intratu"al

device insertion was unevent'ul in all cases% with accepta"letolerance in spite o' the lac+ o' general anesthesia, oreover% therewas no complication associated with the hysteroscopic procedures%and patient satis'action with the procedure was high% inagreement with previous reports :5D%55;,!ne patient who had long standing in'ertility with unilateralhydrosalpinx "ecame pregnant spontaneously shortly a'terintratu"al device insertion, A very similar case has "een reportedpreviously :51;, In our opinion% these cases support the hypothesiso' an adverse e&ect o' hydrosalpinges on implantation% and suggestthat there is a "ene-cial e&ect 'rom their occlusion% in "oth naturaland assisted conception,revious wor+ on IVF in Essure6occluded hydrosalpinxpatients :1%5>; reported results similar to the normal population:1; or somewhat lower :5>;, IVF data were not reported :1%5>;%however% and the control group was a"sent :5>; or the register o' Society 'or Assisted Reproduction Technologies was used ascontrol group :5>;, The analysis o' our IVF results was hampered "y the smallnum"er o' cases in our population as well as "y the nonrandomi(eddesign o' our study, regnancy rates were somewhatlower% presuma"ly as a conse8uence o' the signi-cantly'ewer oocytes o"tained 'rom Essure carriers, In our opinion thenum"er o' oocytes recovered "eing so much smaller should "eattri"uted not to an adverse e&ect o' the device% "ut rather to thepreviously existing poor prognosis 'actors% such as the high rateso' elevated levels o' FSH and advanced endometriosis amongEssure carriers already "e'ore the insertion, Thus% our experienceindicates that the insertion o' the intratu"al device is a good option "e'ore IVF in cases wherelaparoscopic salpingectomy iscontraindicated, The potential relationship "etween the Essure metallic coilsprotruding into the uterine cavity and o"stetric complications is animportant theoretical concern, To date% a total o' =5 cases o' pregnancies in IVF patients carrying an Essure device have "eenreported% with <> live "irths :1%55%5>;% one preterm twin delivery:3;% 'our miscarriages :5>; and one case o' immature delivery withchorioamnionitis :55;, In this last case% no relationship "etween theEssure device and the o"stetric outcome could "e esta"lished, Nereport a 'urther six pregnancies in Essure carriers% including oneterm vaginal delivery and three preterm cesarean sectiondeliveries, Two o' the preterm deliveries occurred in multiplespregnancies )one triplet* 'ollowing premature rupture o' themem"ranes, These o"stetric complications seemed to "e related tothe multiple pregnancies, In "oth cases% the cesarean sections wereper'ormed without complications and the Essure device wasapparently completely encapsulated and did not extend into the

uterine cavity, There was also one case o' spontaneous pretermrupture o' mem"ranes in a singleton pregnancy% where the role o' the tu"al device remains uncertain, Further% there was a case o' a



meningocele which seems to have had no relation at all to theintratu"al device, Ne also report two cases o' miscarriage,In our series there was one patient who had a complication inwhich association with the Essure device could not "e ruled out,She was a woman in whom I occurred during su"stitutivehormonal therapy 'or ! )0 months a'ter Essure insertion*, Hercondition did not respond to anti"iotic therapy and "ilateraladnexectomy was re8uired, It could "e speculated that the

proximal occlusion o' the tu"e could "e associated withaccumulation o' 7uid inside the tu"e% not allowing tu"al 7uid toegress into the uterine cavity% and perhaps there"y 'avoring asu"se8uent in'ection,It should "e remem"ered% however% that Essure was notemployed as an alternative to easy salpingectomies% "ut rather'or cases in which not even laparoscopic tu"al occlusion was'easi"le, Hypothetically% laparoscopic occlusion could also cause anincrease in the accumulation o' 7uid in the 'allopian tu"es, In ouropinion% laparoscopy should "e the -rst step 'or diagnosing% andwhere possi"le treating% the hydrosalpinges, Indeed% it o&ers theadvantage o' providing a more accurate diagnosis o' otherconditions )such as tu"erculosis in our series*, Ne conclude thatwhen laparoscopic surgical treatment o' a hydrosalpinx is not'easi"le% or when laparoscopy is not recommended% hysteroscopicinsertion o' the Essure device is a reasona"le option% which%

moreover% provides in'ormation concerning the status o' theuterine cavity,

Hysteroscopic Hydrosalpinx Occlusion With Essure Device in IVF Atients When Salpingectomy or...

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