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Experience of 1000 falloposcopic tuboplasty (FT) cases: FT is a novel, patient friendly and effective regimen for tubal factor infertility before ART
CONCLUSIONS: We found no significant difference in the ongoing pregnancy rate between patients undergoing endometrial trimming at the time of hysteroscopy and those undergoing diagnostic hysteroscopy alone. The endometrial tickle theory suggests that mechanical disruption of the endometrium may increase receptivity in the infertile population. However, this study shows no additional benefit (or harm) of mechanical disruption of the endometrium at the time of hysteroscopy compared to diagnostic hysteroscopy alone. Supported by: None.
Monday, November 10, 2008 4:45 pm O-108 EXPERIENCE OF 1000 FALLOPOSCOPIC TUBOPLASTY (FT) CASES: FT IS A NOVEL, PATIENT FRIENDLY AND EFFECTIVE REGIMEN FOR TUBAL FACTOR INFERTILITY BEFORE ART. M. Sawabe, A. Fukuda, A. Hamada, M. Sonoda, Y. Nakaoka, Y. Morimoto. Reproductive Endocrinology and Infertility, IVF Osaka Clinic, Higashi-Osaka, Osaka, Japan; IVF Osaka Clinic, Higashi-Osaka, Japan; IVF Namba Clinic, Osaka, Japan. OBJECTIVE: Tubal factor is a major cause of female infertility. The narrowest portion of the fallopian tube, extending from uterotubal ostium to ampullary-isthmic junction, is vulnerable and often causes infertility by occlusion (Oc) or stenosis (St). FT is the procedure of transcervical balloon tuboplasty combined with retrograde imaging of endotubal lining and can be performed outpatient bases. Although ART has been used for tubal factor as standard treatment, we apply FT as an initial treatment. The present study was conducted to evaluate whether outpatient FT is effective to recover tubal patency and achieve pregnancy from our experience of 1000 cases. DESIGN: Retrospective study at private setting infertility clinic. MATERIALS AND METHODS: One thousand patients with tubal Oc and/or St either unilaterally or bilaterally diagnosed by hysterosalpingography were treated by FT from January, 2002 through June, 2007. Indications for FT were tubal lesions without hydrosalpinges. Severe male factor patients were excluded. FT were performed under uterine cervical block. Eversion balloon catheter of 6 cm was used to recanalize affected oviducts. It was considered successful when more than 5 cm of the balloon advanced from tubal ostium. Patients were followed by conventional infertility treatments such as timed intercourse or IUI for at least 6 months. Success of FT procedures and subsequent pregnancy were analyzed. RESULTS: Nine hundred eighty eight out of 1000 patients (98.8%) were treated successfully with FT. Overall pregnancy rate after FT was 27.1% (268/988). Twenty four point seven percent of patients (170/688) with bilateral tubal lesions (Oc&Oc;169pt., Oc&St; 217pt and St&St; 302pt.) and 34.8% of patients with unilateral tubal lesion (Oc;141pt. and St;140pt.) achieved pregnancy. Pregnancy and condition of tubal linings were as follows; post inflammation image: 25.3% (57/225pt.), adhesions: 31.6% (113/357pt.) and other abnormalities: 19.0% (111/583pt.). Six ectopic pregnancies (2.2%) took place. The pregnancy took place in 4 months and 23 days on average after FT. The average duration of infertility of pregnant patients was 3 years and 9 months. CONCLUSIONS: FT could be performed out patient bases and achieved acceptable pregnancy rate (27.1%) with reasonable ectopic rate for tubal factor infertility. Moreover, FT is not only bringing natural pregnancies, but also patient friendly procedure. The present study has proven that outpatient FT could be the first option for tubal factor infertility patients before IVF. Supported by: None.
Monday, November 10, 2008 5:00 pm O-109 A RANDOMIZED CONTROLLED STUDY COMPARING TWO STANDARDIZED CLOSURE METHODS OF LAPAROSCOPIC PORT SITES. K. Chen, A. Klapper, H. Voige, G. Del Priore. OB/GYN, NY Downtown Hospital, Weill Cornell University, New York City, NY. OBJECTIVE: To compare post-operative wound characteristic of octyl cyanoacrylate tissue adhesive (OC) with standard suture technique for the closure of laparoscopic port sites. DESIGN: Randomized Phase III controlled clinical trial.
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Abstracts
MATERIALS AND METHODS: All participants had 2 lateral lower abdominal 5mm ports for advanced laparoscopic procedures. Closure technique was randomized in each patient with one side port closed using OC and the opposite port closed with 4-0 monofilament delayed absorbable suture (Monocryl, Ethicon, Somerville, NJ). Wound evaluation was performed 2-4 weeks after surgery during a regularly scheduled post-op visit. The Hollander Wound Evaluation Scale (HWES, including step-off of borders, contour irregularities, margin separation, edge inversion, excessive distortion and overall appearance) was used for cosmetic evaluation. Complications, such as erythema, warmth, tenderness, drainage and wound infection were evaluated by the patient and primary surgeon. Analysis of complication was performed using c2 test and cosmetic evaluation including individual components of the HWES was compared with t test with P< 0.05 considered significant. RESULTS: Currently 31 patients with 62 port site wounds have been randomized. The number of patients with erythema (1/31 vs. 13/31, p<0.05), tenderness (1/31 vs. 18/26, p<0.05) and drainage (1/31 vs. 9/31, p <0.05) was lower with OC than that with sutures. Although no difference was noted in the overall HWES for cosmetic evaluation, margin separation (1/31 vs. 6/31, p<0.05) was lower with OC. CONCLUSIONS: Laparoscopic ports closed with OC had fewer early complications such as wound erythema, tenderness and drainage. The study also showed that the ports closed with OC had better cosmetic appearance such as lower margin separation. A larger sample size of longer duration is needed to confirm these results. Supported by: None.
PRIZE PAPER CANDIDATES Tuesday, November 11, 2008 10:15 am O-110 THE PHOSPHODIESTERASE 3 INHIBITOR ORG 9935 PREVENTS PREGNANCY IN CYNOMOLGUS MACAQUES. J. T. Jensen, R. L. Stouffer, J. E. Stanley, M. B. Zelinski. Department of Obstetrics & Gynecology, Oregon Health & Science University, Portland, OR; Division of Reproductive Sciences, Oregon National Primate Research Center, Beaverton, OR. OBJECTIVE: To determine whether the phosphodiesterase (PDE) 3 inhibitor ORG 9935 has potential as a contraceptive in primates. DESIGN: Nonhuman primate, in vivo controlled experiment. MATERIALS AND METHODS: Regularly-cycling adult female cynomolgus macaques of proven fertility (n¼16) were divided into 2 equal harems, and group-housed in separate but identical indoor facilities. During a pretreatment phase, ovulation was confirmed by monitoring cycle length and serum hormone levels, and animals were conditioned to enter a training tunnel for daily vaginal swab examinations to detect menstruation or mating. Monkeys were treated for 7 months with either a placebo oral food treat (controls) or the PDE 3 inhibitor ORG 9935 as a daily food treat (150 mg/kg), or as a weekly subcutaneous injection (150 mg/kg in CAPTEX 355 (Abitec)) if they refused oral dosing. After one month on study drug or placebo, a male monkey of proven fertility was introduced into each harem for 6 months. Females underwent weekly monitoring of progesterone (P) and ultrasound evaluation for pregnancy if P remained elevated for more than 3 weeks. Pregnant animals were removed from the group and underwent medical abortion. ORG 9935 values were evaluated using High-Performance Liquid Chromatography. RESULTS: In the control group, 7/8 (88%) monkeys became pregnant following one to six mated cycles of exposure. Although the pregnancy rate in ORG 9935-treated monkeys (4/8; 50%, p ¼ 0.5) did not differ from controls, 2 treated monkeys were mated during all 6 ovulatory cycles and did not conceive. Both of these animals became pregnant within 4 cycles after stopping ORG 9935. The other 2 animals were discontinued prematurely from the protocol for medical reasons. No animal became pregnant in a cycle when the serum level of ORG 9935 exceeded 300nmol/l. CONCLUSIONS: These preliminary results demonstrate that ORG 9935 may prevent pregnancy in primates at serum concentrations above 300 nmol/l, and that the effect is reversible. Further work directed toward drug toxicity, availability and administration are warranted to determine whether PDE 3 inhibitors have potential clinical use as contraceptives in women. Supported by: The National Institute of Child Health and Human Development through grants HD042710; U54 HD18185; U54 HD 031398; and NCRR RR00163.
Vol. 90, Suppl 1, September 2008
Monday, November 10, 2008 4:45 pm O-108 EXPERIENCE OF 1000 FALLOPOSCOPIC TUBOPLASTY (FT) CASES: FT IS A NOVEL, PATIENT FRIENDLY AND EFFECTIVE REGIMEN FOR TUBAL FACTOR INFERTILITY BEFORE ART. M. Sawabe, A. Fukuda, A. Hamada, M. Sonoda, Y. Nakaoka, Y. Morimoto. Reproductive Endocrinology and Infertility, IVF Osaka Clinic, Higashi-Osaka, Osaka, Japan; IVF Osaka Clinic, Higashi-Osaka, Japan; IVF Namba Clinic, Osaka, Japan. OBJECTIVE: Tubal factor is a major cause of female infertility. The narrowest portion of the fallopian tube, extending from uterotubal ostium to ampullary-isthmic junction, is vulnerable and often causes infertility by occlusion (Oc) or stenosis (St). FT is the procedure of transcervical balloon tuboplasty combined with retrograde imaging of endotubal lining and can be performed outpatient bases. Although ART has been used for tubal factor as standard treatment, we apply FT as an initial treatment. The present study was conducted to evaluate whether outpatient FT is effective to recover tubal patency and achieve pregnancy from our experience of 1000 cases. DESIGN: Retrospective study at private setting infertility clinic. MATERIALS AND METHODS: One thousand patients with tubal Oc and/or St either unilaterally or bilaterally diagnosed by hysterosalpingography were treated by FT from January, 2002 through June, 2007. Indications for FT were tubal lesions without hydrosalpinges. Severe male factor patients were excluded. FT were performed under uterine cervical block. Eversion balloon catheter of 6 cm was used to recanalize affected oviducts. It was considered successful when more than 5 cm of the balloon advanced from tubal ostium. Patients were followed by conventional infertility treatments such as timed intercourse or IUI for at least 6 months. Success of FT procedures and subsequent pregnancy were analyzed. RESULTS: Nine hundred eighty eight out of 1000 patients (98.8%) were treated successfully with FT. Overall pregnancy rate after FT was 27.1% (268/988). Twenty four point seven percent of patients (170/688) with bilateral tubal lesions (Oc&Oc;169pt., Oc&St; 217pt and St&St; 302pt.) and 34.8% of patients with unilateral tubal lesion (Oc;141pt. and St;140pt.) achieved pregnancy. Pregnancy and condition of tubal linings were as follows; post inflammation image: 25.3% (57/225pt.), adhesions: 31.6% (113/357pt.) and other abnormalities: 19.0% (111/583pt.). Six ectopic pregnancies (2.2%) took place. The pregnancy took place in 4 months and 23 days on average after FT. The average duration of infertility of pregnant patients was 3 years and 9 months. CONCLUSIONS: FT could be performed out patient bases and achieved acceptable pregnancy rate (27.1%) with reasonable ectopic rate for tubal factor infertility. Moreover, FT is not only bringing natural pregnancies, but also patient friendly procedure. The present study has proven that outpatient FT could be the first option for tubal factor infertility patients before IVF. Supported by: None.
Monday, November 10, 2008 5:00 pm O-109 A RANDOMIZED CONTROLLED STUDY COMPARING TWO STANDARDIZED CLOSURE METHODS OF LAPAROSCOPIC PORT SITES. K. Chen, A. Klapper, H. Voige, G. Del Priore. OB/GYN, NY Downtown Hospital, Weill Cornell University, New York City, NY. OBJECTIVE: To compare post-operative wound characteristic of octyl cyanoacrylate tissue adhesive (OC) with standard suture technique for the closure of laparoscopic port sites. DESIGN: Randomized Phase III controlled clinical trial.
S40
Abstracts
MATERIALS AND METHODS: All participants had 2 lateral lower abdominal 5mm ports for advanced laparoscopic procedures. Closure technique was randomized in each patient with one side port closed using OC and the opposite port closed with 4-0 monofilament delayed absorbable suture (Monocryl, Ethicon, Somerville, NJ). Wound evaluation was performed 2-4 weeks after surgery during a regularly scheduled post-op visit. The Hollander Wound Evaluation Scale (HWES, including step-off of borders, contour irregularities, margin separation, edge inversion, excessive distortion and overall appearance) was used for cosmetic evaluation. Complications, such as erythema, warmth, tenderness, drainage and wound infection were evaluated by the patient and primary surgeon. Analysis of complication was performed using c2 test and cosmetic evaluation including individual components of the HWES was compared with t test with P< 0.05 considered significant. RESULTS: Currently 31 patients with 62 port site wounds have been randomized. The number of patients with erythema (1/31 vs. 13/31, p<0.05), tenderness (1/31 vs. 18/26, p<0.05) and drainage (1/31 vs. 9/31, p <0.05) was lower with OC than that with sutures. Although no difference was noted in the overall HWES for cosmetic evaluation, margin separation (1/31 vs. 6/31, p<0.05) was lower with OC. CONCLUSIONS: Laparoscopic ports closed with OC had fewer early complications such as wound erythema, tenderness and drainage. The study also showed that the ports closed with OC had better cosmetic appearance such as lower margin separation. A larger sample size of longer duration is needed to confirm these results. Supported by: None.
PRIZE PAPER CANDIDATES Tuesday, November 11, 2008 10:15 am O-110 THE PHOSPHODIESTERASE 3 INHIBITOR ORG 9935 PREVENTS PREGNANCY IN CYNOMOLGUS MACAQUES. J. T. Jensen, R. L. Stouffer, J. E. Stanley, M. B. Zelinski. Department of Obstetrics & Gynecology, Oregon Health & Science University, Portland, OR; Division of Reproductive Sciences, Oregon National Primate Research Center, Beaverton, OR. OBJECTIVE: To determine whether the phosphodiesterase (PDE) 3 inhibitor ORG 9935 has potential as a contraceptive in primates. DESIGN: Nonhuman primate, in vivo controlled experiment. MATERIALS AND METHODS: Regularly-cycling adult female cynomolgus macaques of proven fertility (n¼16) were divided into 2 equal harems, and group-housed in separate but identical indoor facilities. During a pretreatment phase, ovulation was confirmed by monitoring cycle length and serum hormone levels, and animals were conditioned to enter a training tunnel for daily vaginal swab examinations to detect menstruation or mating. Monkeys were treated for 7 months with either a placebo oral food treat (controls) or the PDE 3 inhibitor ORG 9935 as a daily food treat (150 mg/kg), or as a weekly subcutaneous injection (150 mg/kg in CAPTEX 355 (Abitec)) if they refused oral dosing. After one month on study drug or placebo, a male monkey of proven fertility was introduced into each harem for 6 months. Females underwent weekly monitoring of progesterone (P) and ultrasound evaluation for pregnancy if P remained elevated for more than 3 weeks. Pregnant animals were removed from the group and underwent medical abortion. ORG 9935 values were evaluated using High-Performance Liquid Chromatography. RESULTS: In the control group, 7/8 (88%) monkeys became pregnant following one to six mated cycles of exposure. Although the pregnancy rate in ORG 9935-treated monkeys (4/8; 50%, p ¼ 0.5) did not differ from controls, 2 treated monkeys were mated during all 6 ovulatory cycles and did not conceive. Both of these animals became pregnant within 4 cycles after stopping ORG 9935. The other 2 animals were discontinued prematurely from the protocol for medical reasons. No animal became pregnant in a cycle when the serum level of ORG 9935 exceeded 300nmol/l. CONCLUSIONS: These preliminary results demonstrate that ORG 9935 may prevent pregnancy in primates at serum concentrations above 300 nmol/l, and that the effect is reversible. Further work directed toward drug toxicity, availability and administration are warranted to determine whether PDE 3 inhibitors have potential clinical use as contraceptives in women. Supported by: The National Institute of Child Health and Human Development through grants HD042710; U54 HD18185; U54 HD 031398; and NCRR RR00163.
Vol. 90, Suppl 1, September 2008