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Surgical Procedures that enhance Fertility? Tommaso Falcone,M.D. Professor & Chair Obstetrics &Gynecology Cleveland Clinic.

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Presentation on theme: "Surgical Procedures that enhance Fertility? Tommaso Falcone,M.D. Professor & Chair Obstetrics &Gynecology Cleveland Clinic."— Presentation transcript:

1 Surgical Procedures that enhance Fertility? Tommaso Falcone,M.D. Professor & Chair Obstetrics &Gynecology Cleveland Clinic

2 Surgical Procedures that enhance Fertility? Enhance Spontaneous Pregnancy Enhance IVF outcomes Fertility preserving surgery versus fertility enhancing surgery

3 The Most Common Causes: in Western Society Tubal disease: 15% Male factor:25% (40%) Ovulation disorders:25% Endometriosis:10% Unexplained:20%

4 Multiple Gestation Epidemic

5 Changing IVF paradigm Guidelines for number of embryos to transfer –Typically 1 embryo

6 Tubal Disease: Result of Treatment Depends on severity of disease Distal tubal disease –Preserved mucosal folds –Microsurgical technique for repair CO 2 laser makes no difference

7 Salpingostomy: Result of Treatment Dubuisson et al HR1994 Canis et al F&S 1991 Donnez et al J Gynecol Surg 1989 Taylor et al F&S 2001 Milingos et al J Am Assoc Gynecol Laparosc 2000 N=81 PR% 37 N=87 PR% 40 N=25 PR % 20 N=139 PR% 25 N=61 PR% 21

8 Fimbrioplasty: Results of Treatment: Dubuisson et al F&S 1990 Saleh & Dlugi F&S 1997 N=31 PR% 35 N=88 PR 40%

9 Proximal Tubal obstruction Hysteroscopic surgery 48% PR

10 Peri-tubal adhesions No laparoscopic study One prospective study of open treatment –n-=69 Tulandi et al 1990 Am J Obstet Gynecol –Pregnancy rates at 12 and 24 months Treated32 and 45% Control11 and 16%

11 When is it feasible? Importance of other pathologies Age of patient Patient preference Desire for “natural” procreation Insurance coverage Results of ART program

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13 Treatment effect Treatment effect large enough to be clinically relevant? Number needed to treat (NNT): number of subjects that must be treated to achieve one more outcome with intervention than control NNT=1/Risk difference Risk difference: Event rate treated group- Event rate control

14 Stage 1 & 2 endometriosis Canadian study –N=172 treated & N=169 untreated –PR% 29% treated & 17% untreated –NNT= 1/.12=8.3 –NNT=9, 95 % CI, 5,33 Italian study –N=54 treated & N=47 no treatment –PR% 22% & 28%

15 Treatment Effect Canadian study PR for pregnancies more than 20 weeks of gestation, Italian study reported any pregnancies –Combine the studies for pregnancies over 20 weeks: 27% (treated) & 18% ( non treated): NNT=12 ( 95% CI 6,112) –20% prevalence of endometriosis –60 diagnostic laparoscopies to get an extra pregnancy

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17 Endometriomas Drainage has a high recurrence rate Need to excise the cyst –Cochrane database 2005 Hart R et al –Excision of cyst associated with a reduced rate of recurrence; reduced symptom recurrence and increased spontaneous pregnancy rates compared with ablative surgery

18 Endometriomas Unresponsive to medical therapy –Surgery required to remove them Jones & Sutton 2002; Alborzi et al 2004 –Surgical removal % young women will conceive spontaneously –Laparoscopic removal of endometrioma represents the first line treatment for infertile women

19 Stage III&IV Endometriosis: reoperation or IVF Pagidas, Falcone et al Fertility & Sterility 1996 Previously operated patients with infertility Reoperation PR were –6% at 3 months –18% at 7 months –24 % at 9 months

20 Reoperation for Stage III&IV Endometriosis ? Pagidas et al Fertility & Sterility 1996

21 Stage III&IV endometriosis After initial unsuccessful operative procedure to restore fertility, IVF-ET appears to be a superior alternative to re- operation In patients with chronic pain reoperation is a viable alternative

22 Endometrial Polyps Afifi K et al Eur J Obstet Gynecol Reprod Biol –Meta-analysis management of endometrial polyps in subfertile women: a systematic review –Significantly improved PR in women undergoing IUI

23 Leiomyomas & Infertility: Submucosal fibroids –PR after hysteroscopic resection up to 43% Goldberg F&S 1995 Hart Br J Obstet & Gynecol 1999 Bernard Eur J Obstet Gynecol Reprod Biol 2000 Intramural fibroids distort the uterine cavity

24 Myomectomy: Indications Shokeir et al 2010 Fertil Steril 2010 –Randomized matched trial; –Unexplained infertility –Type 0 and Type 1 myomas –Hysteroscopic surgery was performed –PR significantly improved ( 63 % vs 28 %)

25 Ideal Candidate for Hysteroscopic procedure Single intracavitary myoma or one involving less than 50 % of the myometrium (Type 0 or 1) and up to 3cm in diameter. Uterine size less than weeks Normal hemoglobin and normal electrolytes

26 General Assumptions The pregnancy rate 1-2 years following laparosocpic or laparotomy myomectomy in an infertile woman ( with no other problems) is approximately –40-60% Laparoscopic Surgery is superior to laparotomy –Challenges are

27 Reproductive Outcome: Pregnancy rates Seracchioli et al 2000 –RCT (only study Cochrane database) –Pregnancy rate: over 3 years AM:56% LM:54% –Spont Ab: AM 20% LM:12% –Preterm labor:AM:7% LM:5% –C/S: AM: 77% & LM:65% –No ruptures

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29 EndoWrist TM Instrumentation Modeled after the human wrist. Full range of motion High-strength cable system –Transpose fingers to instrument tips

30 Summary of Literature on Robotic Myomectomy Surgery NumberRemoved of Robotic Type of Myomas of Robotic Type of Myomas Author Year Cases Study Weight Results Advincula200435PreliminaryMean = Robotic myomectomy AP et alexperience gis new promising approach Mao SP2007 1Case reportNot Successful et alavailablerobotically-assisted excision of large uterine myoma measuring 9x8x7cm Bocca S2007 1Case reportNotAchievement of et alavailableuncomplicated full term pregnancy after robotic myomectomy

31 Summary of Literature on Robotic Myomectomy Surgery NumberRemoved of Robotic Type ofMyomas of Robotic Type of Myomas Author Year Cases StudyWeight Results Author Year Cases Study Weight Results Advincula200729RetrospectiveMean = Robotic myomectomy AP, et alcase matched gapproach is between comparable to open robotic and approach regarding open short term surgical myomectomyoutcome and costs Nezhat C200915Retrospective Mean = 116gRobotic myomectomy et alcase matched (min 25-max 350)ghad significant longer between surgical time without robotic and offering any major laparoscopic advantages myomectomy

32 Cleveland Clinic- Obstet Gynecol 2011 Abdominal (n=393) Laparoscopic (n=93) Robotic (n=89) p value Age years ( 5.61) ( 9.17) ( 5.18)< Weight Kg 75.5 (62.8,90.7) 64.8 (59.1, 76.66) ( 57.6, 82.5)< Height cm ( 13.17) ( 6.19) (6.62)0.97 BMI kg/m227(23,32)24.1 ( 22, 28.1) 25.1 ( 22.1, 29.4)< 0.001

33 Maximum Diameter of the Resected Myoma (in cm) by Surgical Approach AbdominalLaparascopicRobotic ( P=0.036)

34 Weight of the Resected Myomas (in grams) by Surgical Approach 0 2,500 AbdominalLaparascopicRobotic 2,000 1,500 1, Overall P < RM vs LM < 0.001

35 The Actual Operative Time (in minutes) by Surgical Approach AbdominalLaparascopicRobotic Overall P < RM vs LM NS

36 The Intra−operative Blood Loss (mL) by Surgical Approach 0 2,500 AbdominalLaparascopicRobotic 2,000 1,500 1, Overall P < RM vs LM NS

37 The Postoperative Hemoglobin Drop (gm/dL) by Surgical Approach AbdominalLaparascopicRobotic Overall P < RM vs LM NS

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39 45° 8-10 cm

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41 Solution: Side Docking – 4 arm

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47 Surgical Procedures that will improve IVF outcome

48 Hydrosalpinx: meta-analysis Zeyneloglu et al Fert Steril 1998 –13 published studies, 10 abstracts –Pregnancy rate decreased by half compared to controls (fresh & frozen cycles) –50% lower implantation rate –Higher miscarriage rates Strandell et al HR 1999 –Prospective RCT –204 patients –Salpingectomy group: 36.6% –No surgery: 24%

49 Hydrosalpinx: effect of salpingectomy Subgroup analysis: Hydrosalpinges visible at ultrasound appeared to benefit the most (Strandell et al)

50 Hydrosalpinx: alternative treatment Proximal tubal cauterization Surrey & Schoolcraft F&S 2001 –Salpingectomy: 57% –Bipolar proximal tubal occlusion: 46%; P=NS

51 Impact of Fibroids on IVF General observations –Submucosal fibroids & intramural leiomyoma that distort the cavity have an impact IVF outcome –Subserosal leiomyomas do not affect the on IVF fertility parameters –Although less clear, there is some evidence to support the concept that intramural leiomyomas without cavity distortion may affect IVF parameters such as pregnancy rates or implantation rates. However PR & delivery rates are still high.

52 Effect of intramural fibroids on IVF outcome Sunkara et al HR 2010 –Meta-analysis –Intramural fibroids without cavity distortion –19 studies-6087 cycles –Significant decrease in live birth and clinical pregnancy rates –This does not mean that removal will restor PR to the levels expected in women without fibroids

53 Impact of Fibroids on IVF Generally if there is a distortion of the uterine cavity: remove the fibroids Because of the lack of consistent or well designed studies, & high reported PR, prophylactic myomectomy pre-IVF if the cavity is normal should be individualized & not routine. No data for fibroids >5-7cm.

54 Impact of endometriosis on IVF outcome: Meta-analysis 22 studies ( 2377 with endometriosis & 4383 without endometriosis); Barnhart et al F&S 2002 Stage I & II- 21 % per cycle ( control 27.7%) –Decrease in implantation & fertilization rates Stage III & IV –13.8 % per cycle ( control 27.7%) –Decrease in the number of oocytes retrieved

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56 Oocytes retrieved: previously operated endometriomas adapted from review Somigliana et al 2006 Endometriosis Controls-No endo Al-Azemi et al Canis et al Donnez et al Marconi et al Geber et al ** Pabucco et al ** Esinler et al 2006 Uni (10.8) Bi (7.1)**

57 Oocytes retrieved: previously operated endometriomas Endometrioma size >3cm but no upper limit given or mean diameter; others 2-5cm Pregnancy rates : –Not different in most studies –Geber et al (in women over 35) & Pabucco decreased PR Signs of decreased ovarian reserve –Marconi et al total dose of gonadotropin was higher –Esinler et al decreased antral follicle count & total dose of gonadotropin was higher

58 Oocytes retrieved: operated vs. non- operated normal ovary Control ovary Operated ovary Nargund et al * Loh et al Donnez et al Ho et al * Somigliana et al * Wong et al

59 Bilateral Endometriomas Somigliana et al HR 2008 Endometrioma group=68 patients Control group ( no ovarian surgery)=136 patients Day 3 FSH of cases> controls Number follicles/oocytes/embryos decreased/Implantation rate-lower PR/DR cases per transfer ( 14%/8%) vs. controls (28 %/25%)

60 General Consensus Reduced responsiveness in operated patients Pregnancy rate not significantly affected-if unilateral but reduced if bilateral Large number of variables that determine outcome ( size, age, duration of infertility etc) CAUSE- surgical technique ? Actual presence of the cyst?

61 Endometrioma surgery Outcome is dependent on technique Minimize damage to the surrounding tissue

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63 Will surgery improve IVF outcome? Surgery within 6 months of IVF vs. 6 months to 5 years No effect of the time interval between surgery & oocyte retrieval Surrey & Schoolcraft

64 Endometriosis surgery prior to IVF: Conclusions If patient symptomatic, there does not appear to be a deleterious affect on outcome if surgery performed If patient asymptomatic: Case by Case


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