Surgical Procedures that enhance Fertility?

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Surgical Procedures that enhance Fertility?

• Cleveland Clinic

• Tommaso Falcone,M.D.
• Professor Chair
• Obstetrics Gynecology

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Surgical Procedures that enhance Fertility?

• Enhance Spontaneous Pregnancy
• Enhance IVF outcomes
• Fertility preserving surgery versus fertility
  enhancing surgery

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The Most Common Causes in Western Society

• Tubal disease 15
• Male factor 25 (40)
• Ovulation disorders 25
• Endometriosis 10
• Unexplained 20

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Multiple Gestation Epidemic
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Changing IVF paradigm

• Guidelines for number of embryos to transfer
• Typically 1 embryo

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Tubal Disease Result of Treatment

• Depends on severity of disease
• Distal tubal disease
• Preserved mucosal folds
• Microsurgical technique for repair
• CO2 laser makes no difference

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Salpingostomy Result of Treatment

• Dubuisson et al HR1994
• Canis et al FS 1991
• Donnez et al J Gynecol Surg 1989
• Taylor et al FS 2001
• Milingos et al J Am Assoc Gynecol Laparosc 2000

• N81 PR 37
• N87 PR 40
• N25 PR 20
• N139 PR 25
• N61 PR 21

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Fimbrioplasty Results of Treatment

• Dubuisson et al FS 1990
• Saleh Dlugi FS 1997

• N31 PR 35
• N88 PR 40

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Proximal Tubal obstruction

• Hysteroscopic surgery 48 PR

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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
• Treated 32 and 45
• Control 11 and 16

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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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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
• NNT1/Risk difference
• Risk difference Event rate treated group- Event
  rate control

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Stage 1 2 endometriosis

• Canadian study
• N172 treated N169 untreated
• PR 29 treated 17 untreated
• NNT 1/.128.3
• NNT9, 95 CI, 5,33
• Italian study
• N54 treated N47 no treatment
• PR 22 28

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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) NNT12
  ( 95 CI 6,112)
• 20 prevalence of endometriosis
• 60 diagnostic laparoscopies to get an extra
  pregnancy

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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

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Endometriomas

• Unresponsive to medical therapy
• Surgery required to remove them
• Jones Sutton 2002 Alborzi et al 2004
• Surgical removal
• 40-50 young women will conceive spontaneously
• Laparoscopic removal of endometrioma represents
  the first line treatment for infertile women

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Stage IIIIV Endometriosis reoperation or
IVFPagidas, 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

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Reoperation for Stage IIIIV Endometriosis
?Pagidas et alFertility Sterility 1996
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Stage IIIIV 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

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Endometrial Polyps

• Afifi K et al Eur J Obstet Gynecol Reprod Biol-
  2010
• Meta-analysis management of endometrial polyps in
  subfertile women a systematic review
• Significantly improved PR in women undergoing IUI

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Leiomyomas Infertility

• Submucosal fibroids
• PR after hysteroscopic resection up to 43
• Goldberg FS 1995
• Hart Br J Obstet Gynecol 1999
• Bernard Eur J Obstet Gynecol Reprod Biol 2000
• Intramural fibroids distort the uterine cavity

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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 )

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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 12-14 weeks
• Normal hemoglobin and normal electrolytes

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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

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Reproductive Outcome Pregnancy rates

• Seracchioli et al 2000
• RCT (only study Cochrane database)
• Pregnancy rate over 3 years
• AM56 LM54
• Spont Ab AM 20 LM12
• Preterm laborAM7 LM5
• C/S AM 77 LM65
• No ruptures

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EndoWristTM Instrumentation

• Modeled after the human wrist. Full range of
  motion
• High-strength cable system
• Transpose fingers to instrument tips

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Summary of Literature on Robotic Myomectomy
Surgery
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Summary of Literature on Robotic Myomectomy
Surgery
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Cleveland Clinic- Obstet Gynecol 2011
Abdominal (n393) Laparoscopic (n93) Robotic (n89) p value
Age years 36.93 ( 5.61) 39.57 ( 9.17) 36.62 ( 5.18) lt 0.001
Weight Kg 75.5 (62.8,90.7) 64.8 (59.1, 76.66) 68.04 ( 57.6, 82.5) lt 0.001
Height cm 163.92 ( 13.17) 164.02 ( 6.19) 163.63 (6.62) 0.97
BMI kg/m2 27(23,32) 24.1 ( 22, 28.1) 25.1 ( 22.1, 29.4) lt 0.001
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Maximum Diameter of the Resected Myoma (in cm) by
Surgical Approach
30
20
10
(P0.036)
0
Abdominal
Laparascopic
Robotic
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Weight of the Resected Myomas (in grams) by
Surgical Approach
2,500
Overall P lt 0.001 RM vs LM lt 0.001
2,000
1,500
1,000
500
0
Abdominal
Laparascopic
Robotic
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The Actual Operative Time (in minutes)by
Surgical Approach
350
300
Overall P lt 0.001 RM vs LM NS
250
200
150
100
50
Abdominal
Laparascopic
Robotic
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The Intra-operative Blood Loss (mL) by Surgical
Approach
2,500
Overall P lt 0.001 RM vs LM NS
2,000
1,500
1,000
500
0
Abdominal
Laparascopic
Robotic
37
The Postoperative Hemoglobin Drop (gm/dL) by
Surgical Approach
7
6
Overall P lt 0.001 RM vs LM NS
5
4
3
2
1
0
Abdominal
Laparascopic
Robotic
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8-10 cm
45
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Solution Side Docking 4 arm
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Surgical Procedures that will improve IVF outcome
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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

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Hydrosalpinx effect of salpingectomy

• Subgroup analysis Hydrosalpinges visible at
  ultrasound appeared to benefit the most
  (Strandell et al)

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Hydrosalpinx alternative treatment

• Proximal tubal cauterization
• Surrey Schoolcraft FS 2001
• Salpingectomy 57
• Bipolar proximal tubal occlusion 46 PNS

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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.

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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

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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 gt5-7cm.

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Impact of endometriosis on IVF outcome
Meta-analysis

• 22 studies ( 2377 with endometriosis 4383
  without endometriosis) Barnhart et al FS 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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Oocytes retrieved previously operated
endometriomasadapted from review Somigliana et
al 2006
Endometriosis Controls-No endo
Al-Azemi et al 2000 6.90.7 7.10.5
Canis et al 2001 9.46.2 10.96.5
Donnez et al 2001 10.64.2 8.66.3
Marconi et al 2002 7.53.9 8.75.1
Geber et al 2002 9.85.4 12.05.9
Pabucco et al 2004 5.71.3 7.21.5
Esinler et al 2006 Uni (10.8) Bi (7.1) 11.16.1
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Oocytes retrieved previously operated
endometriomas

• Endometrioma size gt3cm 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

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Oocytes retrieved operated vs. non-operated
normal ovary
Control ovary Operated ovary
Nargund et al 1996 8.95.1 6.35.2
Loh et al 1999 3.6 4.6
Donnez et al 2001 6.63.5 5.23.0
Ho et al 2002 6.14.1 2.92.6
Somigliana et al 2003 4.22.5 2.01.5
Wong et al 2004 5.20.8 5.60.9
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Bilateral Endometriomas

• Somigliana et al HR 2008
• Endometrioma group68 patients
• Control group ( no ovarian surgery)136 patients
• Day 3 FSH of casesgt controls
• Number follicles/oocytes/embryos
  decreased/Implantation rate-lower
• PR/DR cases per transfer ( 14/8) vs. controls
  (28 /25)

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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?

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Endometrioma surgery

• Outcome is dependent on technique
• Minimize damage to the surrounding tissue

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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

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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