1. Tuboplasty vs. IVF - ET Tuboplasty vs. IVF - ET Seok Hyun Kim, M.D. Department of Obstetrics and Gynecology College of Medicine, Seoul National University Seoul, Korea

2. Tubal Factor Infertility # Etiology # Etiology Infection Infection History of laparotomy History of laparotomy Congenital anomaly Congenital anomaly PID PID STD STD

3. Treatment of Tubal Factor Infertility 1. Surgical Approach 1. Surgical Approach Laparotomy : Microsurgical technique Laparotomy : Microsurgical technique Laparoscopy / Pelviscopy Laparoscopy / Pelviscopy Transcervical : Tubal recanalization Transcervical : Tubal recanalization 2. Assisted Reproductive Technology (ART) 2. Assisted Reproductive Technology (ART) IVF - ET IVF - ET

4. Choice of Treatment Options n Age of patient n Etiology of tubal disease n Extent of tubal disease n History of laparotomy n Other causes of infertility n Cost : medical / surgical

5. Tubal Surgery / Tuboplasty 1. Adhesiolysis 1. Adhesiolysis Salpingoovariolysis Salpingoovariolysis 2. Proximal Tubal Occlusion 2. Proximal Tubal Occlusion Tubocornual reanastomosis Tubocornual reanastomosis Fluoroscopic recanalization Fluoroscopic recanalization Transcervical balloon tuboplasty Transcervical balloon tuboplasty 3. Distal Tubal Occlusion 3. Distal Tubal Occlusion Fimbrioplasty Fimbrioplasty Neosalpingostomy Neosalpingostomy 4. Tubal sterilization (T/L) 4. Tubal sterilization (T/L) Tubal reanastomosis (TR) Tubal reanastomosis (TR)

6. Tubal Surgery # Prevention of adhesions Anti-inflammatory agent Anti-inflammatory agent Fibrinolytic agent Fibrinolytic agent Barrier agent Barrier agent Meticulous bleeding control Meticulous bleeding control Pelviscopic operation Pelviscopic operation

7. Pelviscopic Tubal Surgery n Lower cost n Shorter hospitalization n Faster recovery n Better compliance

8. Prognostic Variables of Tubal Surgery Author AFS, 1988 Winston & Margara, 1991 Variables in classification Distal ampullary diameter Tubal wall thickness Mucosal folds at neostomy site Type and extent of adhesions Degree of mucosal damage Degree of tubal fibrosis Presence of isthmic disease Quality of tubal / ovarian adhesions

9. Peritubal Adhesion Microsurgery Microsurgery PR 21~62% PR 21~62% Filmy adhesion Filmy adhesion PR 39% (Hulka, 1982) PR 39% (Hulka, 1982) CPR 68% (Oelsner, 1994) CPR 68% (Oelsner, 1994) Dense adhesion Dense adhesion PR 21% (Hulka, 1982) PR 21% (Hulka, 1982) CPR 34% (Oelsner, 1994) CPR 34% (Oelsner, 1994) cf. IVF-ET : CPR 49~51% (Guzik, 1986; Tan, 1992) cf. IVF-ET : CPR 49~51% (Guzik, 1986; Tan, 1992)

10. Peritubal Adhesion n Kelly & Roberts, 1983 1 year follow-up 1 year follow-up PR 24% PR 24% Interval to pregnancy 5.2 months Interval to pregnancy 5.2 months n Donnez & Casanas-Roux, 1986 Term PR 64% Term PR 64% Ectopic PR 2% Ectopic PR 2%

11. Adhesiolysis by Microsurgery Author Patients Duration of Intrauterine Ectopic Term follow-up preg. preg. preg. Diamond (1979) 140 > 1 year 86 (61) 8 (6) 80 (57) Hulka (1982)23 filmy6 months-4 years 9 (39) 0 (0) 8 (35) 24 dense 5 (21) 1 (4) 4 (17) Frantzen & Schlosser 491 year 20 (41) 2 (4) 19 (39) (1982) Kelly & Roberts 2128 months 5 (24) 0 (0) 4 (19) (1983) Donnez & Casanas- 4212-86 months - 1 (2) 27 (64) Roux (1986) Luber et al. (1986) 133 years 8 (62) 1 (8) 7 (54) Jacobs et al. (1988) 1550 months 7 (47) 0 (0) 6 (40) Singhal et al. (1991) 7855 months 32 (41) 4 (5) 29 (37) Oelsner et al. (1994)19 filmy101 months 13 (68) 3 (16) 8 (42) 32 dense 11 (34) 1 (3) 6 (19) Values in parentheses are percentages.

12. Pelviscopic Adhesiolysis n Gomel, 1989 PR 57~62% PR 57~62% Half of pregnancy : < 6 months Half of pregnancy : < 6 months n Dense type adhesion Laparotomy more effective Laparotomy more effective due to technical problems due to technical problems

13. Adhesiolysis by Laparoscopy Author Patients Duration of Intrauterine Ectopic Term follow-up preg. preg. preg. Bruhat et al. (1982) 66 moderate > 18 months 36 (55) 5 (8) - 27 severe 12 (44) 2 (7) - Donnez (1987)32 avascular 18 months - - 20 (62) 22 vascular 11 (50) Fayez (1988) 49 2 years 28 (57) 2 (4) 23 (47) Gomel (1989) 92 > 9 months 57 (62) 5 (5) 54 (59) Values in parentheses are percentages.

14. Proximal Tubal Obstruction n Tubocornual implantation Standard Tx. until 1970’s Standard Tx. until 1970’s n Tubocornual reanastomosis Recent improvement in results : PR ~45% Recent improvement in results : PR ~45% Donnez & Casanas-Roux, 1986 Donnez & Casanas-Roux, 1986 Damaged isthmic length < 1 cm : PR 45% Damaged isthmic length < 1 cm : PR 45%  1 cm : PR 22%  1 cm : PR 22%

15. Proximal Tubal Obstruction Proximal Tubal Obstruction Tubocornual reanastomosis Tubocornual reanastomosis McComb & Gomel, 1980 McComb & Gomel, 1980 PR 58%, Term PR 53%, Ectopic PR 12% PR 58%, Term PR 53%, Ectopic PR 12% Jacob, 1988 Jacob, 1988 PR 65%, Ectopic PR 6% PR 65%, Ectopic PR 6% Dubuisson, 1997 Dubuisson, 1997 Interval to pregnancy 10.1 months Interval to pregnancy 10.1 months Term PR 57%, Ectopic PR 11% Term PR 57%, Ectopic PR 11% cf. Comparable to IVF-ET : CPR 49% (Guzik, 1986)

16. Proximal Tubal Obstruction # Avoidance of peritoneal entry # Avoidance of peritoneal entry Prevention of adhesion formation Prevention of adhesion formation Use of USG, hysteroscopy, fluoroscopy, Use of USG, hysteroscopy, fluoroscopy, and recanalization fallopioscopy and recanalization fallopioscopy Fluoroscopic recanalization : PR 31% Fluoroscopic recanalization : PR 31% Transcervical balloon tuboplasty : PR 34% Transcervical balloon tuboplasty : PR 34%

17. Transvaginal Bougie Dilatation and Selective Salpingography Lang & Dunaway, 1996 Lang & Dunaway, 1996 Case 187 Case 187 Recanalization 145 (77.5%) Recanalization 145 (77.5%) Pregnancy 24 Pregnancy 24 PR / Case 12.8% PR / Case 12.8% Major complication 1 Major complication 1 Indications > Indications > Salpingitis isthmica nodosa 62 Salpingitis isthmica nodosa 62 Salpingitis and perisalpingitis 71 Salpingitis and perisalpingitis 71 Endometriosis 8 Endometriosis 8 Failed surgical anastomosis 43 Failed surgical anastomosis 43

18. Proximal Tubal Operation by Microsurgery Author Patients Duration of Intrauterine Ectopic Term follow-up preg. preg. preg. Rock et al. (1979)** 52 50 months 13 (25) 2 (4) 8 (15) McComb & Gomel 38 - 23 (61) 2 (5) 20 (53) (1980)* Winston (1980)* 43 - - 1 (2) 16 (37) Frantzen & Chlosser 28 > 1 year 12 (43) 2 (7) 12 (43) (1982) * Gomel (1983)* 48 > 1 year 30 (63) 3 (6) 27 (56) McComb (1986)* 26 50 months 15 (58) 3 (12) 14 (54) Jacobs et al. (1988)* 17 3 years 11 (65) 1 (6) 8 (50) Donnez & Casanas- 82 - - 6 (7) 36 (44) Roux (1986)* Singhal et al. (1991)* 27 50 months 9 (33) 2 (8) 6 (22) Singhal et al. (1991)** 9 50 months 2 (22) 0 (0) 1 (11) Dubuisson et al. (1997)* 120 3 years 89 (74) 13 (11) 68 (57) *Tuboconual anastomosis ** tubocornual implantation Values in parentheses are percentages.

19. Fallopioscopic Tuboplasty Sueoka, 1998 Sueoka, 1998 50 patients with occluded tubes 50 patients with occluded tubes HSG, Rubin test, Hysteroscopic hydrotubation HSG, Rubin test, Hysteroscopic hydrotubation 102 tubes treated during 53 attempts 102 tubes treated during 53 attempts Overall patency rate 79.4% after 1-3 months Overall patency rate 79.4% after 1-3 months 11 pregnancies over 3-year follow-up 11 pregnancies over 3-year follow-up

20. Distal Tubal Obstruction Distal Tubal Obstruction n Reconstructive surgery Fimbrioplasty Fimbrioplasty Neosalpingostomy Neosalpingostomy - Success : degree of tubal or peritubal disease. - Success : degree of tubal or peritubal disease. - Poor prognostic factors of neosalpingostomy - Poor prognostic factors of neosalpingostomy Hydrosalpinx with diameter of 3 cm or larger Hydrosalpinx with diameter of 3 cm or larger No visible fimbriae No visible fimbriae Dense pelvic adhesion Dense pelvic adhesion

21. Salpingostomy by Microsurgery Values in parentheses are percentages. Author Patients Duration of Intrauterine Ectopic Term follow-up preg. preg. preg. Swolin (1975) 338 - 13 years 13 (39) 8 (24) 12 (36) Gomel (1978) 41 > 1 year 12 (29) 5 (12) 11 (27) DeCherney & Kase 54> 2 years 20 (37) 4 (7) 14 (26) (1981) Mage & Bruhat (1983) 68>18 months 19 (28) 6 (9) 14 (21) Tulandi & Vilos (1985) 672 years 15 (22) 3 (4) - Russel et al. (1986) 686 years 28 (42) 12 (18) 28 (42) Jacobs et al. (1988) 713 years 29 (41) 8 (11) 23 (32) Donnez & Casanas- 8342 months - 6 (7) 26 (31) Roux (1986) Luber et al. (1986) 1712 - 86 months 2 (12) 2 (12) 2 (12) Schlaff et al. (1990) 95 4 years 19 (20) 7 (7) - Winston & Margara 3231-10 years 106 (33)32 (10) 72 (23) (1991) Singhal et al. (1991) 9750 months 33 (34) 6 (6) 28 (29) Audebert et al. (1991) 135 2 years 38 (28)16 (12) -

22. Fimbrioplasty by Microsurgery Author Patients Duration of Intrauterine Ectopic Term follow-up preg. preg. preg. Patton (1982) 35 2 years 21 (60) 1 (3) - Jacobs et al. (1988) 29 3 years 20 (69) 2 (7) 17 (59) Donnez & Casanas- 132 36 months - 2 (2) 79 (60) Roux (1986) Luber et al. (1986) 20 12-86 months 6 (30) 3 (15) 3 (15) Audebert et al. 76 2 years 27 (36) 5 (7) - (1991) Values in parentheses are percentages.

23. Distal Tubal Obstruction Superior results with Fimbrioplasty than Neosalpingostomy n Donnez & Casanas-Roux, 1986 Fimbrioplasty : PR 60% Fimbrioplasty : PR 60% Neosalpingostomy : PR 31% Neosalpingostomy : PR 31% n Posaci, 1999 Presence of dense adhesion, thick tubal wall, and Presence of dense adhesion, thick tubal wall, and abnormal tubal mucosa : Term PR 3% abnormal tubal mucosa : Term PR 3% Absence of these factors : Term PR 59% Absence of these factors : Term PR 59% Both proximal and distal injury IVF-ET indicated

24. Distal Tubal Obstruction Pelviscopic surgery Pelviscopic surgery Lower PR, compared with microsurgery Lower PR, compared with microsurgery Success rates related to extent of disease Success rates related to extent of disease n Audebert, 1998 PR : 51% PR : 51% Ectopic PR : 23% Ectopic PR : 23%

25. Author Patients Type of Duration of Intrauterine Ectopic Term operation follow-up preg. preg. preg. Fayez (1983) 14 Fimbrioplasty 2 years 3 (21) 2 (14) 3 (21) 19 Salpingoneostomy 2 years 0 (0)2 (11) 0 (0) Daniel & 21 Salpingostomy 18 months 4 (19) 1 (5) 2 (10) Herbert (1984) Dubuisson et al. 31 Fimbrioplasty 18 months 8 (26)3 (10) 7 (23)* (1990) Salpingoneostomy 18 months Canis et al. 87 Fimbrioplasty 3 years 10 (29)1 (3) - (1991) Salpingostomy 29 (33)6 (7) Audebert et al 24 Fimbrioplasty 2 years 4 (17)1 (4) - (1991) 31 Salpingostomy 4 (13)2 (6) McComb & 22 Salpingostomy > 1 year - 1 (5) 5 (23) Paleologou (1991) Dubuisson et al. 81 Salpingostomy 3-60 months 26 (32)4 (5) 26 (32) (1994) Audebert et al. 35 Fimbrioplasty 2-5 years 18 (51)8 (23) 13 (37) (1998) * For the total group Values in parentheses are percentages. Distal Tubal surgery by Laparoscopy

26. Tubal Reanastomosis Performed in 0.2% of T/L patients n Gomel, 1980 PR : 64%, Ectopic PR : 1% PR : 64%, Ectopic PR : 1% Interval to pregnancy : 10.2 months Interval to pregnancy : 10.2 months n Kim et al, 1997 (n=1,118) Anatomic patency rate : 88.2% Anatomic patency rate : 88.2% PR : 54.8%, DR : 72.5% PR : 54.8%, DR : 72.5% The longer the postop. residual tubal length, The longer the postop. residual tubal length, the shorter the interval to pregnancy. the shorter the interval to pregnancy.

27. Prognosis of TR depends on Method of ligation Method of ligation Repair site of tube Repair site of tube Residual tubal length Residual tubal length Other causes of infertility Other causes of infertility # Bipolar coagulation : PR 49% # Bipolar coagulation : PR 49% Ring, clip : PR 67% Ring, clip : PR 67% Pomeroy T/L : PR 75% Pomeroy T/L : PR 75% Tubal Reanastomosis

28. n Better prognosis with small difference in diameter of reconstructed tubal locations of reconstructed tubal locations e.g. isthmus - isthmus (I-I) e.g. isthmus - isthmus (I-I) cornua - isthmus (I-I) cornua - isthmus (I-I) n Gomel & Swolin, 1980 Low PR : < 4 cm of postop. tubal length Low PR : < 4 cm of postop. tubal length Inverse correlation between postop. tubal length Inverse correlation between postop. tubal length and interval to pregnancy and interval to pregnancy Tubal Reanastomosis

29. n Preoperative diagnostic laparoscopy Method and location of ligation Method and location of ligation Potential postop. tubal length Potential postop. tubal length Coexistent pelvic disease Coexistent pelvic disease n In older women > 40 yrs TR (Trimpos & Kemper, 1980) TR (Trimpos & Kemper, 1980) PR : 45%, Interval to pregnancy 5.5 months PR : 45%, Interval to pregnancy 5.5 months IVF-ET (Tan, 1992) IVF-ET (Tan, 1992) CPR : 10% CPR : 10%  TR indicated after 3 cycles of IVF-ET  TR indicated after 3 cycles of IVF-ET Tubal Reanastomosis

30. Reversal of Tubal Ligation by Microsurgery Author Patients T/L Type of Duration of Intrauterine Ectopic Term techniques TR follow-up preg. preg. preg. Winston (1977) 16 Partial resection, Tubocornual - 11 (69) 1 (6) - diathermy Gomel (1980) 118 Mostly Pomeroy Tubotubal < 40 months 76 (64) 1 (1) 69 (58) Silber & Cohen 25 Mostly Tubocornual > 1 year 14 (56) 1 (4) - (1980) Coagulation Tubotubal Winston (1980) 62 - Tubotubal - 37 (60) 2 (3) - 43 - Tubocornual 26 (60) 1 (2) Rock et al. 22 Fallopian ring Tubotubal 40 months 20 (91) 2 (9) 19 (86) (1987) 58 Unipolar cautery Tubotubal 40 months 38 (66) 8 (14) 30 (52) Trimbos-Kemper 45 Coagulation 15 (33) 3 (7) (1990) 9 Pomeroy - 12-29 months 5 (56) 0 (0) 26 (33)* 24 Rings and clips 15 (63) 0 (0) * For the total group Values in parentheses are percentages.

31. Fecundability of Tuboplasty n Proximal tubal obstruction 3.5% (Gillett, 1989) 3.5% (Gillett, 1989) n Distal tubal obstruction 2~3% (Williams, 1988; Canis, 1991) 2~3% (Williams, 1988; Canis, 1991) n Tubal reanastomosis 8% (Henderson, 1984) 8% (Henderson, 1984) n Secondary tuboplasty 1% (Lauritsen, 1982) 1% (Lauritsen, 1982) Expertise required : tubal surgery specialist Expertise required : tubal surgery specialist

32. IVF - ET Alternative of choice to surgical approach Alternative of choice to surgical approach Dominant role in treatment of tubal factor infertility Dominant role in treatment of tubal factor infertility Growing number of qualified IVF centers Growing number of qualified IVF centers Nearly equal to availability of tubal surgery Nearly equal to availability of tubal surgery Requirement of expertise and credentialing Requirement of expertise and credentialing Tubal surgery can be performed, although perhaps less Tubal surgery can be performed, although perhaps less successfully, by those without speciality training. successfully, by those without speciality training.

33. Benadiva, 1995 Benadiva, 1995 Is pelvic reconstructive surgery obsolete? Is pelvic reconstructive surgery obsolete? Penzias, 1996 Penzias, 1996 Is there ever a role for tubal surgery? Is there ever a role for tubal surgery? Dubuisson, 1998 Dubuisson, 1998 Are there still indications for tubal surgery in infertility? Are there still indications for tubal surgery in infertility? Status of ART

34. Tuboplasty vs. IVF-ET Procedures TR (1990) Fimbrial recanalization (1990) Transcervical tuboplasty (1990) Salpingolysis (1991) Laparoscopic fimbrioplasty (1991) Laparoscopic salpingolysis (1992) Laparoscopic distal tuboplasty (1993) Tubal reconstruction (1996) SART/ASRM IVF registry (1995) SART/ASRM IVF registry (1997) Pregnancy Rate 49 - 75 % 34 % 31 % 30 - 60 % 30 - 70 % 62 - 67 % 27 % 40 % 28.4 % 28.9 %

35. Comparison of Reported Outcomes for ART Procedures No. of cycles ET / retrieval (%) No. of clinical preg. Delivery /retrieval (%) Ectopic preg. /ET (%) SART & ASRM, 1997 IVF 33,032 92.8 8,975 28.4 0.9 IVF + ICSI 18,312 94.3 6,072 27.1 0.6 GIFT 1,943 98.6 627 30.0 1.0

36. Standard IVF-ET by Maternal Age SART & ASRM,1997 < 35 yrs, male factor (-) 35 - 37 yrs, male factor (-) 38 - 40 yrs, male factor (-) > 40 yrs, male factor (-) Cancellation rate (%) 10.2 14.8 19.3 24.4 Delivery / retrieval (%) 33.9 29.4 21.2 9.4

37. Tuboplasty or IVF ? n n Tuboplasty Mild or moderate tubal disease Young female n n IVF-ET Extensive pelvic adhesion Old age Impossible tubal reconstruction due to absence of tubes or history of tuberculous salpingitis Failed tubal surgery Existence of other infertility factors

38. Considerations for Tuboplasty or IVF ? n Technical view : Invasiveness Infertility factors involved Infertility factors involved n Nontechnical view : Cost Wishes of patients Wishes of patients n Surgery : Specialty training n IVF-ET : Expertise and credentialing n Development of operative laparoscopy, microsurgery

39. Comparison of Cost per Delivery Cost per delivery Holst, 1991 (Norway) Neumann, 1994 (USA) Van Voorhis, 1997 (USA) Tubal surgery $ 17,000 $ 50,000 $ 76,232 IVF-ET $ 12,000 $ 66,000 $ 43,138

40. Patient Counselling n n Fecundability Tuboplasty : 2-4% IVF - ET : 20% n n Successful tuboplasty : more than one pregnancy possible n n Women’s age, infertility factor n n Take-home-baby rate and CPR of IVF, No. of IVF cycles n n Potential complications Multiple pregnancy, abortion, ectopic pregnancy

41. Tuboplasty vs. IVF-ET Conclusions 1. The goal for infertile couples should be live birth or 1. The goal for infertile couples should be live birth or at least the ability to feel that they did their best. at least the ability to feel that they did their best. 2. These options should be carefully considered and 2. These options should be carefully considered and individualized, regarded as complementary, individualized, regarded as complementary, not competitive, to achieve the desired goal. not competitive, to achieve the desired goal.