invo/vagina complex replaces conventional incubators

1
OBJECTIVE: While the vast majority of embryo transfers (ET) are per- formed without anesthesia, conscious sedation is sometimes utilized for pa- tients with severe anxiety or a history of technically difficult ET. This study’s objective was to determine whether administration of anesthesia during ET affects IVF outcome. DESIGN: Retrospective case-control study. MATERIALS AND METHODS: 84 patients undergoing fresh IVF cycles between January 2004 and December 2011 were studied. 42 patients’ first ET under anesthesia (propofol) and 42 controls undergoing ET without anes- thesia were included. Controls were matched for year of treatment, age, use of ultrasound guidance during ET, gravidity, parity, number of previous IVF cycles, body mass index, number of embryos transferred, embryo quality, and etiology of infertility. T-test and Fisher’s exact test were used for statistical analysis. RESULTS: The mean age of the patients was 35.9 in both groups. The dif- ferences in implantation rate, total pregnancy rate, clinical pregnancy rate, and miscarriage rate of patients undergoing ET with and without anesthesia were not statistically significant. A trend towards higher live birth rate was observed in the group without anesthesia, but this difference was also not statistically significant. Pregnancy outcome in patients undergoing ET with and without anesthesia ET with anesthesia ET without anesthesia P n¼ 42 42 Implantation rate 0.22 0.25 0.70 Total pregnancy rate (%) 38 52 0.27 Clinical pregnancy rate (%) 31 45 0.26 Live birth rate (%) 21 40 0.09 Miscarriage rate (%) 44 23 0.29 CONCLUSION: Conscious sedation administered during ET does not appear to significantly affect IVF outcome. These findings indicate that ET under anesthesia is a safe option in the rare instances in which it is deemed clinically necessary. The slightly higher live birth rate in the non-anesthesia group may be due to the fact that the ET under anesthesia group represented particularly technically challenging cases, although these findings did not reach statistical significance. P-1318 Thursday, October 17, 2013 ART BACK- UP SYSTEM (A-BUS) TO PREVENT HUMAN ERRORS IN IVF LABORATORY USING BARCODE. K. Takahashi, T. Mukaida. Hiroshima HART Clinic, Hiroshima, Japan. OBJECTIVE: We would like to present a newly developed ART back-up system using barcodes to minimize human error in IVF laboratory. DESIGN: Retrospective study. MATERIALS AND METHODS: This ART back- up system (A-bus) was developed by Asahi Tekunoion, (Tokyo, Japan,) under our orders and introduced in Hiroshima HART clinic in March 2011. The barcode which contains a couple’s ID number and their birth dates can identify couples and their samples. The barcode seals are attached to the woman’s wrist band (size 7x7mm), the cup of semen sample, the IVF dishes, and the frozen embryo containers (4x4mm) prior to IVF/ICSI. Both nurse and embryologist identify the woman using a hand- held terminal prior to oocyte retrieval and embryo transfer. An embryologist checks the bar- code every time before she starts each IVF procedure without need for double checks. In case of an error, a loud buzzer sound notifies both the embryologist and any other staff in the room of the mistake. The errors are automatically logged in the computer system. RESULTS: Between March 2011 and February 2013, a total of 987 cycles of oocyte retrieval, 423 cycles of fresh ET and 1058 cycles of vitrified and warmed blastocyst transfer were carried out by 3 physicians and 6 embryol- ogists. Although we discontinued double checks by two embryologists, there was no a single human error, not even a near miss. Since the introduction of A-bus, both patients and staff have been satisfied with the system and re- ported an increased sense of safety. No mechanical trouble has been observed in A- bus for two years. CONCLUSION: A-bus can minimize human error and promote a sense of safety and satisfaction among both patients and staff. It has also made it possible to reduce the number of embryologists, especially those working on weekends. Therefore, we conclude A-bus is useful and a cost effective tool in ART clinics. P-1319 Thursday, October 17, 2013 INVO/VAGINA COMPLEX REPLACES CONVENTIONAL INCUBATORS. E. E. Lucena, A. A. Moran, A. A. Saa, C. C. Pulido, O. O. Lombana, E. E. Bonilla. Colombian Center of Fertility and Sterility, Bogota, Cundinamarca, Colombia. OBJECTIVE: We assessed the outcome of this procedure, employing the specially designed INVOcellÔ device, in combination with a mild ovarian stimulation protocol; with the aim of evaluate its usefulness as an alternative treatment option for infertile couples without severe male factor. DESIGN: The present study was carried out at CECOLFES, Bogota, Colombia. The study was approved by the institutional ethics committee. MATERIALS AND METHODS: 125 cycles were performed (June/ 2009 - May/2011). A mean of 4.2 was placed per INVOcellÔ device. The device was preloaded with 1.1 mL of pre-gazed and pre-warmed culture medium and a count of 35.000 to 50.000 motile spermatozoa. After 72 hours of one step culture, the device was removed from the vaginal cavity. RESULTS: One hundred twenty-five (125) cycles combining the INVO procedure and mild ovarian stimulation protocol were performed. A total of 812 oocytes were retrieved, for an average of 6.5 per puncture. A mean of 4.2 oocytes were placed for insemination per the INVO device. On average 2.6 embryos per cycle were obtained, for a cleavage rate of 63%, out of which a mean of 2.1 embryos were transferred per cycle, for a total of 114 transfers (91.2%). Cycle distribution per patient’s age groups was seventeen for %29, 54 for 30–34, 48 for 35–39, and 6 for R40 years old. CONCLUSION: INVO is a simple procedure that does not require complex laboratory equipment. INVO does not require complicated maintenance. INVO produces high-quality embryos that result in a good rate of clinical pregnancy per cycle (40%) and a lower rate of mul- tiple gestations (<12%). INVO has good acceptance because of patient involvement during the initial stage of embryo development, with every positive and significant psychological effects. INVO makes it possible to offer treatment to infertile couples in small medical facilities practically anywhere. Supported by: The authors would like to express their appreciation to Clara Esteban, Ph.D., and Eliana Bonilla M.S., for the editing and critical review of this paper. P-1320 Thursday, October 17, 2013 THE ASSESSMENT OF OOCYTE RETRIEVAL AND BLASTOCYST FORMATION BY CHANGING THE ASPIRATION PRESSURE IN WOMEN UNDERGOING IN AN IN VITRO FERTILIZATION. T. Okubo, a,b M. Shozu, b T. Hayashi, a H. Ishikawa, a,b T. Segawa, a S. Teramoto. a a Advanced Medical Research Institute of Fertility, Shinbashi Yume Clinic, Minatoku, Tokyo, Japan; b Chiba University, Chuoku, Chiba, Japan. OBJECTIVE: We have recently developed a fine (23G) needle for follicular aspiration, instead of 22G needle, for pain-less and complica- tion-less oocyte retrieval. We optimized the follicle aspiration pressure and tested whether the use of 23G needle improves blastocyst formation rate. DESIGN: This is prospective non-randomized expiatory study intending to seek the optimum aspiration pressure. A total of 2,691 cycles of 1,811 women who were treated with a natural cycle IVF protocol between 2011 March and 2012 December. MATERIALS AND METHODS: LH surge was triggered at <200pg estra- diol or at <15mm of follicular diameter by a use of nasal buserelin spray (300 ug) and 30-34h after follicles were aspirated from large- (L, >15mm) and small (S, <11mm) follicles. The needlepoint, original crafted needle (Tera- moto-Shibori), is narrowed to 23 G smoothly from 20G shaft to minimize ef- fect of laminar flow. Oocytes were processed to ICSI and expanded blastocysts were frozen. RESULTS: The number of retrieved oocytes per follicle was decreased in 23G groups compared to that in 22G group. This recovered by increasing aspiration pressures but almost all of the increases were destroyed oocytes. After all, the numbers of undestroyed oocytes retrieved by 23G needle were not different between pressure groups and remained somewhat low. By comparison, the blastocyst formation ratio (per follicle) was higher in FERTILITY & STERILITY Ò S527

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OBJECTIVE: While the vast majority of embryo transfers (ET) are per-formed without anesthesia, conscious sedation is sometimes utilized for pa-tients with severe anxiety or a history of technically difficult ET. This study’sobjective was to determine whether administration of anesthesia during ETaffects IVF outcome.

DESIGN: Retrospective case-control study.MATERIALS ANDMETHODS: 84 patients undergoing fresh IVF cycles

between January 2004 and December 2011 were studied. 42 patients’ first ETunder anesthesia (propofol) and 42 controls undergoing ET without anes-thesia were included. Controls were matched for year of treatment, age,use of ultrasound guidance during ET, gravidity, parity, number of previousIVF cycles, body mass index, number of embryos transferred, embryoquality, and etiology of infertility. T-test and Fisher’s exact test were usedfor statistical analysis.

RESULTS: The mean age of the patients was 35.9 in both groups. The dif-ferences in implantation rate, total pregnancy rate, clinical pregnancy rate,and miscarriage rate of patients undergoing ET with and without anesthesiawere not statistically significant. A trend towards higher live birth rate wasobserved in the group without anesthesia, but this difference was also notstatistically significant.

Pregnancy outcome in patients undergoing ET with and without anesthesia

ET with anesthesia ET without anesthesia P

FERTILITY & STERI

LITY�

42 42

Implantation rate

0.22 0.25 0.70

Total pregnancy rate (%)

38 52 0.27

Clinical pregnancy rate (%)

31 45 0.26

Live birth rate (%)

21 40 0.09

Miscarriage rate (%)

44 23 0.29

CONCLUSION: Conscious sedation administered during ET does notappear to significantly affect IVF outcome. These findings indicate that ETunder anesthesia is a safe option in the rare instances in which it is deemedclinically necessary. The slightly higher live birth rate in the non-anesthesiagroup may be due to the fact that the ET under anesthesia group representedparticularly technically challenging cases, although these findings did notreach statistical significance.

P-1318 Thursday, October 17, 2013

ART BACK- UP SYSTEM (A-BUS) TO PREVENT HUMAN ERRORSIN IVF LABORATORY USING BARCODE. K. Takahashi,T. Mukaida. Hiroshima HART Clinic, Hiroshima, Japan.

OBJECTIVE: We would like to present a newly developed ART back-upsystem using barcodes to minimize human error in IVF laboratory.

DESIGN: Retrospective study.MATERIALS AND METHODS: This ART back- up system (A-bus)

was developed by Asahi Tekunoion, (Tokyo, Japan,) under our ordersand introduced in Hiroshima HART clinic in March 2011. The barcodewhich contains a couple’s ID number and their birth dates can identifycouples and their samples. The barcode seals are attached to the woman’swrist band (size 7x7mm), the cup of semen sample, the IVF dishes, andthe frozen embryo containers (4x4mm) prior to IVF/ICSI. Both nurseand embryologist identify the woman using a hand- held terminal priorto oocyte retrieval and embryo transfer. An embryologist checks the bar-code every time before she starts each IVF procedure without need fordouble checks. In case of an error, a loud buzzer sound notifies boththe embryologist and any other staff in the room of the mistake. The errorsare automatically logged in the computer system.

RESULTS: Between March 2011 and February 2013, a total of 987 cyclesof oocyte retrieval, 423 cycles of fresh ET and 1058 cycles of vitrified andwarmed blastocyst transfer were carried out by 3 physicians and 6 embryol-ogists. Although we discontinued double checks by two embryologists, therewas no a single human error, not even a near miss. Since the introduction ofA-bus, both patients and staff have been satisfied with the system and re-ported an increased sense of safety. Nomechanical trouble has been observedin A- bus for two years.

CONCLUSION: A-bus can minimize human error and promote a sense ofsafety and satisfaction among both patients and staff. It has also made itpossible to reduce the number of embryologists, especially those workingon weekends. Therefore, we conclude A-bus is useful and a cost effectivetool in ART clinics.

P-1319 Thursday, October 17, 2013

INVO/VAGINA COMPLEX REPLACES CONVENTIONALINCUBATORS. E. E. Lucena, A. A. Moran, A. A. Saa, C. C. Pulido,O. O. Lombana, E. E. Bonilla. Colombian Center of Fertility and Sterility,Bogota, Cundinamarca, Colombia.

OBJECTIVE: We assessed the outcome of this procedure, employingthe specially designed INVOcell� device, in combination with a mildovarian stimulation protocol; with the aim of evaluate its usefulness asan alternative treatment option for infertile couples without severe malefactor.DESIGN: The present study was carried out at CECOLFES, Bogota,

Colombia. The study was approved by the institutional ethicscommittee.MATERIALS AND METHODS: 125 cycles were performed (June/

2009 - May/2011). A mean of 4.2 was placed per INVOcell� device.The device was preloaded with 1.1 mL of pre-gazed and pre-warmedculture medium and a count of 35.000 to 50.000 motile spermatozoa.After 72 hours of one step culture, the device was removed from thevaginal cavity.RESULTS: One hundred twenty-five (125) cycles combining the INVO

procedure and mild ovarian stimulation protocol were performed. A totalof 812 oocytes were retrieved, for an average of 6.5 per puncture. A meanof 4.2 oocytes were placed for insemination per the INVO device. Onaverage 2.6 embryos per cycle were obtained, for a cleavage rate of63%, out of which a mean of 2.1 embryos were transferred per cycle,for a total of 114 transfers (91.2%). Cycle distribution per patient’s agegroups was seventeen for %29, 54 for 30–34, 48 for 35–39, and 6 forR40 years old.CONCLUSION: INVO is a simple procedure that does not require

complex laboratory equipment. INVO does not require complicatedmaintenance. INVO produces high-quality embryos that result in agood rate of clinical pregnancy per cycle (40%) and a lower rate of mul-tiple gestations (<12%). INVO has good acceptance because of patientinvolvement during the initial stage of embryo development, with everypositive and significant psychological effects. INVO makes it possible tooffer treatment to infertile couples in small medical facilities practicallyanywhere.Supported by:The authors would like to express their appreciation to Clara

Esteban, Ph.D., and Eliana BonillaM.S., for the editing and critical review ofthis paper.

P-1320 Thursday, October 17, 2013

THE ASSESSMENT OF OOCYTE RETRIEVAL ANDBLASTOCYST FORMATION BY CHANGING THE ASPIRATIONPRESSURE IN WOMEN UNDERGOING IN AN IN VITROFERTILIZATION. T. Okubo,a,b M. Shozu,b T. Hayashi,a

H. Ishikawa,a,b T. Segawa,a S. Teramoto.a aAdvanced Medical ResearchInstitute of Fertility, Shinbashi YumeClinic,Minatoku, Tokyo, Japan; bChibaUniversity, Chuoku, Chiba, Japan.

OBJECTIVE: We have recently developed a fine (23G) needle forfollicular aspiration, instead of 22G needle, for pain-less and complica-tion-less oocyte retrieval. We optimized the follicle aspiration pressureand tested whether the use of 23G needle improves blastocyst formationrate.DESIGN: This is prospective non-randomized expiatory study intending

to seek the optimum aspiration pressure. A total of 2,691 cycles of 1,811women who were treated with a natural cycle IVF protocol between 2011March and 2012 December.MATERIALSANDMETHODS: LH surgewas triggered at<200pg estra-

diol or at<15mm of follicular diameter by a use of nasal buserelin spray (300ug) and 30-34h after follicles were aspirated from large- (L, >15mm) andsmall (S, <11mm) follicles. The needlepoint, original crafted needle (Tera-moto-Shibori), is narrowed to 23 G smoothly from 20G shaft to minimize ef-fect of laminar flow. Oocytes were processed to ICSI and expandedblastocysts were frozen.RESULTS: The number of retrieved oocytes per follicle was decreased in

23G groups compared to that in 22G group. This recovered by increasingaspiration pressures but almost all of the increases were destroyed oocytes.After all, the numbers of undestroyed oocytes retrieved by 23G needlewere not different between pressure groups and remained somewhat low.By comparison, the blastocyst formation ratio (per follicle) was higher in

S527