Embryo Transfer Catheter Research Articles

Is there any difference in Lactobacillus abundance between age groups during ovarian stimulation in fresh in vitro fertilization (IVF) cycles?

<p><strong>Aim</strong> To investigate an influence of age and body mass index (BMI) as determinants of infertility treatment success in vitro fertilization (IVF) procedures confirmed so far, on the amount of <em>Lactobacillus</em> spp. (LS) and <em>Gardnerella vaginalis</em> (GV) in the endometrium in fresh IVF cycles at the time of embryo transfer.<br /><strong>Methods</strong> This a prospective single-centre study included patients who underwent fresh embryo transfer (ET) in a private IVF Centre. A catheter tip for embryo transfer was used for collecting samples from the endometrial cavity. Real time polymerase chain reaction (RT PCR) was used to determine LS and GV quantity. Patients were divided into two age groups: <35 years and ≥35 years. Normal BMI group included patients with 18.-24.9 kg/m<sup>2</sup>, and the in-creased BMI group patients with BMI ≥ 25kg/m<sup>2</sup>.<br /><strong>Results</strong> Tips for embryo transfer catheters were positive on LS in 55 (96.4%) patients. The median of quantification cycle of RT-PCR (Cq RT-PCR) for LS was 33, and 31 for the younger and older groups, respectively. Twenty-one (36.8%) patients tested positive for GV. The median of Cq RT-PCR for GV was 33 and 34 for the younger and older groups, respectively. There were 36 patients with normal and 18 with increased BMI. BMI showed no correlation with LS amount in the endometrial cavity.<br /><strong>Conclusion</strong> Aging affects the endome-trial microbiome resulting in an increase of <em>Lactobacillus</em> number, but not the number of GV.</p>

P-241 The in vivo human uterine pH and uterine fluid composition differs from pH and composition of clinically used in vitro preimplantation embryo culture media

Abstract Study question To study the pH and uterine fluid composition in the human uterus three days after a positive LH test or ovum pick-up. Summary answer The uterine pH three days after a positive LH test or ovum pick-up was 6.8. Concentrations of 37 components were determined in uterine fluid. What is known already In assisted reproductive technologies (ART), the in vitro culture of human preimplantation embryos is known to play a crucial role in the success of In Vitro Fertilization (IVF) treatments. It affects live birth rates and child outcomes such as birth weight. Numerous commercial embryo culture media are routinely used in clinical practice worldwide, but their composition is primarily based on laboratory-based clinical insights and experimental studies with animal models. Studies on the natural human preimplantation embryo environment during the physiologically relevant time of the menstrual cycle are limited. Study design, size, duration A cross sectional clinical study was conducted to study the uterine pH and the composition of human uterine fluid. The uterine pH was measured in 53 women on the third day after LH surge (N = 46) or ovum pickup (N = 7), as that time in the menstrual cycle is associated with endometrial receptivity for embryo implantation. Twenty-two samples of aspirated uterine fluid, that were collected at the same time, were analyzed for the concentrations of thirty-seven components. Participants/materials, setting, methods Healthy women of reproductive age with normal functional uterine anatomy were included. Uterine pH was determined using pH probe inserted through outer sheath of an Embryo Transfer (ET) catheter at the lithotomy position. Uterine fluid was then aspirated using a syringe connected to outer sheath of this ET catheter. Collected samples were analyzed using a Cobas 8000 chemistry analyser and ultra-performance liquid chromatography-tandem mass spectrometry. Main results and the role of chance The mean pH in the uterine cavity on the third day after a positive LH test (6.75 ± 0.22) or ovum pick-up (6.82 ± 0.18) was clearly lower than the pH used in routine clinical practice for preimplantation embryo culture (pH 7.3 ± 0.1). Calcium, phosphate, lactate(L), pyruvate, albumin and 21 amino acids were present at different concentrations in human uterine fluid compared to most commonly used preimplantation embryo culture media. Immunoglobulins, citrulline, ornithine and uric acid were present in uterine fluid, but not in clinically used culture media. Limitations, reasons for caution As the uterine cavity is only one part of the reproductive tract, our measurements do not fully represent the complete in vivo environment of preimplantation embryo development. We only studied 37 components, recognizing that uterine fluid likely contains additional components. Wider implications of the findings The observed differences between the uterine pH and the composition of uterine fluid and the pH and composition of preimplantation embryo culture media used in routine clinical practice could be a starting point to further optimize in vitro embryo culture in ART treatments. Trial registration number Not applicable

Disposables used cumulatively in routine IVF procedures could display toxicity.

Is there a cumulative toxicity of disposables used in IVF procedures? A toxicity may be detected when consumables are used cumulatively, while no toxicity is detected when the same consumables are used and tested individually. Many components of items used in IVF laboratories may impair human embryonic development. Consequently, it is necessary to screen all reagents and materials which could be in contact with gametes and embryos. Toxicity tests, such as the mouse embryo assay and the human sperm motility assay (HSMA), are used by manufacturers as quality control tools to demonstrate the safety of their products. This evaluation is currently individually performed for each single consumable. However, during an IVF cycle, several devices are used sequentially, potentially creating a cumulative exposure to chemical contaminants, which could not be detected for individually tested consumables. The objective of this observational study conducted from March 2021 to October 2022 was to evaluate with the HSMA methodology if there was a cumulative toxicity when several disposables are sequentially used. Fourteen categories of consumables currently used in routine IVF procedures were studied, which included devices used for sperm and oocyte collection (cups, condoms, and oocyte aspiration needles), manipulation (flasks, tubes, tips, pipettes, embryo transfer catheters, syringes, and gloves), culture (dishes), and storage (straws). After obtaining patient consent, the surplus semen assessed as having normal parameters according to the World Health Organization 2010 criteria were used to perform the HSMAs. First, each consumable was tested individually. Then, associations of three, four, and five consumables, previously validated as non-toxic when tested individually, were analyzed. HSMAs were conducted three times to ensure reproducibility, with a defined toxicity threshold of a sperm motility index (SMI) below 0.85 in at least two of three tests. Thirty-six references of disposables were first individually tested across 53 lots. Forty-nine (92%) demonstrated compliance. However, four (8%) devices revealed toxicity: one lot of 1 ml syringes, two lots of sperm cups, and one lot of 25 cm2 flasks. These four references were excluded from the IVF routine procedures. A total of 48 combinations of consumables were assessed, involving 41 lots from 32 references that were previously individually tested. Among the evaluated combinations, 17 out of 48 (35%) associations exhibited toxicity with a SMI below 0.85 for two of the three tests (n = 8) or all the three tests (n = 9). Notably, three out of 17 (18%) of the three-consumable associations, five out of 16 (31%) of the four-consumable associations, and nine out of 15 (60%) of the five-consumable associations were found not compliant. The toxicity did not originate from a single consumable, because only consumables that were individually pre-validated as non-toxic were included in the combinations, but the toxicity had a cumulative origin. The risk of cumulative toxicity increased with the number of consumables included in the association (Cochran-Mantel-Haenszel statistic, P = 0.013). The high proportion of non-compliant combinations of disposables can be attributed directly to the extreme rigorous extraction conditions employed during the tests, which could deviate from the conditions encountered in routine clinical use. Also, the methodology employed in the HSMAs (e.g. toxicity extraction duration, sperm concentrations, and protein supplementation of the medium) can influence the sensitivity of the tests. This study highlights the significance of performing toxicity testing on devices before introducing them into clinical practice. Disposables should be tested individually to detect immediate toxicities and also in combination. Our results advocate rationalizing the number of consumables used in each IVF procedure and re-evaluating the use of glass consumables. This study received fundings from GCS Ramsay Santé pour l'Enseignement et la Recherche (Paris, France) and the Centre de Biologie Médicale BIOGROUP(Le Chesnay-Rocquencourt, France). The authors declare that they have no conflict of interest that could be perceived as prejudicing the impartiality of the reported research. N/A.

Temperature fluctuations during embryo transfer can be mitigated by optimizing transfer protocol

Research QuestionWhat impact do variations in embryo transfer catheter loading and movement procedures have on temperature and pH fluctuations during embryo transfer? DesignMock embryo transfers were conducted to test the impact of airflow/movement, use of catheter coverings and the type of workstation used for catheter loading on catheter temperature. A thermocouple probe inserted into the tip of the outer catheter or taped to the exterior of the inner catheter recorded temperature within the catheter every 5 sec from time of mock embryo loading (TL) up to 60 sec (TL +60s). Fluctuations in culture medium pH in embryo transfer dishes were monitored. ResultsCatheter temperature was lower at TL+15s (26.8 ±0.61°C) than TL (30.5 ±0.81°C, P <0.05). The rate of cooling during transit was slower when catheters were covered to reduce the cooling effect of air movement (P<0.05). Temperature was better maintained when catheters were loaded in a crib compared to a heated stage, until initiation of transit, when the rate of temperature decrease was similar. Culture medium pH increased faster when embryo transfer dishes remained on a heated stage during the procedure compared to within an open crib. ConclusionsTemperature loss during the ET procedure can be mitigated by reducing transit time and using catheter coverings. Use of a crib for catheter loading only improved temperature stability while the catheter remained in the crib, not during transit, and it reduced pH fluctuations during the procedure.

#133 : Hysteroscopy Guided Embryo Transfer, a Newer Approach for Difficult Embryo Transfer

Background: Embryo transfer (ET) is a crucial step in IVF process. Therefore, difficult ET can significantly impact the odds of implantation. We propose that hysteroscopy guided ET might be a feasible alternative to conventional ultrasound guided ET in such cases. Case Report: This is the case of a 27-year-old woman with six years of primary infertility with severe dysmenorrhoea and menorrhagia. TVS showed a bulky adenomyotic uterus with multiple fibroids primarily in the posterior wall distorting the endometrial cavity and bilateral huge endometriomas. She underwent laparoscopic adenomyomectomy, myomectomy and bilateral Tubo-ovarian mass removal. Subsequently, she underwent IVF with donor eggs after 5 months therapy with long-acting GnRH agonist. Mock ET was attempted but was unsuccessful due to acute anterior flexion of the cervix. So, she was planned for ET under general anaesthesia, but the ET catheter could not be negotiated through the internal os. A 30∘ 3 mm hysteroscope was then inserted through the cervical canal using saline as distension media. Additionally, a small polyp was noted at the internal os blocking the entry of ET catheter. Once the endocervical canal was distended the catheter was negotiated from the side of hysteroscope into the cervical canal and it passed through the internal os easily under direct vision of hysteroscope. The hysteroscope was then withdrawn holding the catheter at its place. Complete evacuation of saline from endometrial cavity was confirmed by trans abdominal USG and a double ET was done under USG guidance. The routine post ET medication protocol was followed. Her Serum [Formula: see text]-hCG result was positive and after an uneventful pregnancy, she delivered healthy twin babies at 35 weeks. Conclusion: The introduction of hysteroscopy guided ET may be a suitable alternative in cases of difficult ET.

Is the presence of mucus and/or blood contamination on the embryo transfer catheter associated with the cycle outcomes ?

Is the presence of mucus and/or blood contamination on the embryo transfer catheter associated with the cycle outcomes ?

The relationship between microbial contaminations of embryo transfer catheters with pregnancy outcome after embryo transfer.

Different stages of assisted reproductive technologies are susceptible to contamination by various microorganisms. The aim of the study was to investigate the relationship between microbial contamination of embryo transfer catheters and the pregnancy outcome after embryo transfer. This cohort study was conducted on 60 patients candied for in vitro fertilization and embryo transfer cycles from 2021 to 2022. All embryos were transferred using a sterile syringe. The catheter contamination was checked by the microbial culture method, and in the case of microbial culture that were negative, polymerase chain reaction was done to confirm the result. The data analyzed using STATA 17 to determine the impact of catheter contamination on the clinical pregnancy rate. The average age of peoples whose microbial culture was positive was lower than that of people whose microbial culture was negative (P<0.05). Also the results showed that people who live in villages have more positive microbial cultures than people who live in cities (P<0.05). Also there is no difference between the number of successful implantations and the pregnancy outcome between people whose microbial culture results were positive or negative. The results of the current study showed that the contamination of the embryo transfer catheter with microorganisms under our investigation did not affect the pregnancy outcome.

Comparison of the effects of soft and firm embryo transfer catheters on clinical pregnancy rates in a homogeneous group of thawed day-5 blastocyst embryo transfers

Comparison of the effects of soft and firm embryo transfer catheters on clinical pregnancy rates in a homogeneous group of thawed day-5 blastocyst embryo transfers

P-139 Comparison of clinical outcomes between two hyaluronan-rich transfer medium

Abstract Study question Is there any difference in effect on clinical outcomes after single vitrified-warmed blastocyst transfer on day 5 using two hyaluronan-rich transfer medium? Summary answer There was no significant difference in rates of clinical pregnancy, implantation and miscarriage between two hyaluronan-rich transfer medium. What is known already Hyaluronan is one of the glycosaminoglycan that is naturally present in female reproductive organs and promotes the endometrial stroma and preimplantation embryo adhesion through CD44 glycoprotein receptors. Several studies demonstrated that use of hyaluronan-enriched transfer medium in women receiving either cleavage-stage or blastocyst-stage embryo improved clinical outcomes compared to the standard medium. However, studies on clinical outcomes according to two transfer medium containing different concentrations of hyaluronan are still insufficient. Study design, size, duration A retrospective study of 1047 vitrified-warmed blastocyst transfer cycles with normal responders (aged 23-35 years) was conducted from September 2018 to November 2022. All cycles with single vitrified-warmed blastocyst transfer on day 5 were evaluated. Only first IVF attempts cycles were included. All women had undergone a GnRH antagonist protocol. Cycles were divided into two groups: Group A (n = 511, EmbryoGlue®, Vitrolife) and Group B (n = 536, UTMTM, Origio). Participants/materials, setting, methods All blastocyst were graded using Gardner and Schoolcraft’s criteria. The vitrified-warmed blastocysts were equilibrated for an average of 47 minutes in two transfers medium until transfer. All blasotcyst were then loaded into an embryo transfer catheter (COOK® medical). The rates of clinical pregnancy, implantation and miscarriage were compared between the two groups. Statistical analyses were conducted using Chi-square test and Independent t-test using SPSS. Main results and the role of chance There were no significant differences in mean female age (31.6 ± 2.5 vs. 31.8 ± 2.3, P = 0.432), mean endometrial thickness (10.4 ± 1.4 vs. 10.3 ± 1.3, P = 0.478), mean oocytes retrieved (20.8 ± 6.8 vs. 20.5 ± 6.9, P = 0.470) and number of transferred good-quality blastocyst stage rate (≥BB grade, 74.8% vs. 72.6%, P = 0.423) between the two groups. We also observed similar rates of biochemical pregnancy (79.5% vs. 78.0%, P = 0.562), clinical pregnancy (71.4% vs. 69.2%, P = 0.434), implantation (72.4% vs. 70.3%, P = 0.459), ongoing pregnancy (67.5% vs. 66.2%, P = 0.659), miscarriage (5.5% vs. 4.3%, P = 0.463) and multiple pregnancy (1.4% vs. 1.6%, P = 0.782) in Group A and B, respectively. Limitations, reasons for caution This study is limited by its retrospective nature in single-center and absence of live birth information. We investigated only single vitrified-warmed blastocyst on day 5 to have data reliability. Therefore, further studies are needed to evaluate our data with vitrified-warmed blastocyst transfer on day 6 or day 7. Wider implications of the findings The present data showed that clinical outcomes were similar between two transfer medium containing different concentrations of hyaluronan. Our findings could have significant clinical implication for selection of the appropriate commercial embryo transfer medium according to IVF laboratory conditions. Trial registration number not applicable

IMPACT OF EMBRYO TRANSFER CATHETER LOADING TECHNIQUE ON CLINICAL OUTCOMES FOLLOWING SINGLE EUPLOID BLASTOCYST TRANSFER

Embryo transfer catheter loading approach has been shown to impact clinical outcomes. Prior studies have indicated that media volume or size/placement of air bubbles may impact success rates. Rinsing of the catheter prior to embryo loading may also be impactful. However, prior studies did not always control for uterine environment or embryo quality. The outcomes following transfer of a single euploid blastocyst in a frozen embryo transfer cycle were compared using two catheter loading approaches.

Investigation into Platelet Rich Plasma (PRP) Infusions Within the Intrauterine Cavity, to Support the Development of Endometrial Lining in Transfer Cycle Patients

Background: Poor endometrial lining is classically referenced as &lt;6mm. Patients commencing Embryo Transfer (ET) cycles can experience issues with lining development and require additional therapy supplementation with the aim of increasing lining thickness prior to ET day. PRP is an adjuvant IVF treatment, known as an infusion therapy, for use in uterine lining development support with the specific aim of increasing endometrial lining outcomes for patients prior to ET. Aim: To assess the effectiveness of PRP infusion therapy on lining development for ET cycle patients. Method: Using the TGA approved Alocuro PRP medical device system, 10mls of whole blood is collected via venepuncture, this sample is centrifuged, to produce 3 identifiable layers; Plasma, Buffy coat and Packed red blood cells. The Buffy coat is collected with 1ml of Plasma and administered via Intrauterine Infusion with an Embryo Transfer Catheter set. Patients are offered this procedure based on clinical histories of poor lining outcomes. Retrospective analysis of all patients undertaking PRP infusion, included assessment of uterine thickness, was conducted. Results: A total of 35 records were identified, of these 2 were cancelled prior to administration of PRP and 7 were removed due to incomplete records of Initial Lining measurement or Final Lining measurement. In the remaining cohort of 26 patients, 2 patients demonstrated regression in their lining, while 24 patients recorded an increase in final lining measurement, with a mean increase of 2mm or 28% over initial lining measurements. When compared with their previous cycle, PRP infusion cycles demonstrated a greater increase in lining thickness between scans, 0.82mm and 1.78mm respectively (p=0.018). Conclusion: PRP treatment appears to show potential in the treatment of poor lining development and warrants further study.

Endometrial microbiome: sampling, assessment, and possible impact on embryo implantation

There is growing interest on the potential clinical relevance of the endometrial microbiome. However, insufficient attention has been given to the methodology of sampling. To minimize contamination, we advocate the use of the double-lumen catheters commonly employed for the embryo transfer. Endometrial fluid samples obtained from 53 women scheduled for IVF were studied for microbiome characterization. Control samples from the vagina of these same women were concomitantly obtained. Samples were analysed by V3–V4–V6 regions of 16S rRNA gene sequencing with Next Generation Sequencing technique. Endometrial Lactobacillus-dominant cases were uncommon compared to previous evidence, being observed in only 4 (8%) women. Taxonomy markedly differed between the endometrial and vaginal microbiomes composition. The most common bacterial genera coincided in only 4 (8%) women. The comparison between women who did and did not subsequently become pregnant failed to identify any microorganism associated with the success of the procedure. However, the endometrial biodiversity resulted higher among pregnant women. Shannon’s Equitability index in pregnant and non pregnant women was 0.76 [0.57–0.87] and 0.55 [0.51–0.64], respectively (p = 0.002). In conclusion, the use of embryo transfer catheters for testing the endometrial microbiome is promising. The scant concordance with vaginal samples supports the validity of this approach. Moreover, our study highlighted a possible beneficial role of a higher biodiversity on endometrial receptivity.

Does the uterine microbiota affect the reproductive outcomes in women with recurrent implantation failures?

BackgroundInefficiency of in vitro fertilization (IVF) programs can be caused by implantation failures. The uterine microbiota can influence the implantation process. However, it still remains unclear whether opportunistic microorganisms detected in the endometrium have a negative impact on the implantation success. The aim of our study was to evaluate the influence of the uterine microbiota on the embryo implantation success in patients undergoing assisted reproductive technologies.MethodsThe study included 130 women diagnosed with infertility. The patients were divided into three groups: group I included women with the first IVF attempt (n = 39); group II included patients with recurrent implantation failure following embryo transfer with ovarian stimulation (n = 27); group III consisted of women with recurrent implantation failure following frozen-thawed embryo transfer (n = 64). We performed microbiological examination of the embryo transfer catheter which was removed from the uterine cavity after embryo transfer; cervical discharge of all the patients was studied as well. Thirty patients were selected for metagenomic sequencing.ResultsThe study showed that the uterine cavity is not free of microorganisms. A total of 44 species of microorganisms were detected: 26 species of opportunistic organisms and 18 species of commensals (14 species of lactobacilli and 4 species of bifidobacteria). Obligate anaerobic microorganisms and Gardnerella vaginalis were detected more frequently in group I compared to group III (strict anaerobes—15.4 and 1.6%; G. vaginalis—12.8 and 1.6%, respectively) (p < 0.05). However, this fact did not have a negative influence on the pregnancy rate: it was 51.3% in group I, it was 29.6% and 35.9% in women with recurrent implantation failures, respectively.ConclusionOpportunistic microorganisms which were revealed in low or moderate titers (103–105 CFU/ml) in the uterine cavity and cervical canal did not affect the pregnancy rate in the women in the study groups. The microflora of the uterine cavity and cervical canal differed in qualitative composition in 87.9% of patients, therefore, we can suggest that the uterine cavity may form its own microbiota. The microbiota of the uterine cavity is characterized by fewer species diversity compared to the microbiota of the cervical canal.

Efficacy and safety of autologous adipose tissue-derived stromal vascular fraction in patients with thin endometrium: a protocol for a single-centre, longitudinal, prospective self-control study

IntroductionEndometrial thickness is an important parameter to evaluate endometrial receptivity. An appropriate endometrial thickness is necessary for both embryo implantation and maintaining normal pregnancy. Women with thin endometrium are one...

Clinical aspects of oocyte retrieval and embryo transfer: tips and tricks for the novice and the expert.

Oocyte retrieval (ovum pick-up) and embryo transfer (ET) are essential steps in in-vitro fertilization and intracytoplasmic sperm injection and over the years, the two procedures were developed in order to improve the clinical outcome. Many suggestions were proposed and applied before, during and after oocyte retrieval such as timing of HCG trigger, pre-operative pelvic scan, vaginal cleansing, type of anesthesia, type and gauge of aspiration needles, aspiration pressure, follicle flushing, and the need for prophylactic antibiotics. Similarly, many steps were suggested and implemented before, during and after ET including patient's position, type of anesthesia/analgesia, dummy (mock) ET, ultrasound-guidance, HCG injection in the uterine cavity, use of relaxing agents, full bladder, removal of the cervical mucus, flushing the cervix with culture medium, type of ET catheter, embryo loading techniques, site of embryo deposition, the use of adherence compounds, as well as bed rest after ET. Complications were also reported with oocyte retrieval and ET. The aim of this review is to evaluate the current practice of these two procedures in the light of available evidence.

Optimizing embryological aspects of oocyte retrieval, oocyte denudation, and embryo loading for transfer.

Oocyte retrieval, oocyte denudation, and embryo transfer are crucial processes during assisted reproduction technology (ART). Air quality in the ART laboratory, temperature, pH of the media used and the time interval between oocyte retrieval and insemination are all critical factors. Anesthesia is required for oocyte retrieval, however, evidence regarding the potential impact of different methods (general anesthesia, conscious sedation, and local anesthesia) on the clinical outcomes is unclear. The optimal timing of oocyte denudation following retrieval has not been established. Regarding the mechanical denudation process, there is a lack of evidence to demonstrate the safest minimum inner diameter of denuding pipettes used to complete the removal of granulosa cells surrounding the oocytes. During embryo transfer, many clinics worldwide flush the catheter before embryo loading, in an attempt to potentially rinse off any toxic agents; however, there is insufficient evidence to show that flushing the embryo transfer catheter before loading increases the success of ART outcome. Considering the serious gaps in knowledge in ART practice, the aim of this review is to provide an updated overview of the current knowledge regarding the various steps and techniques involved in oocyte retrieval, oocyte denudation, and embryo loading for transfer.

Sekonder İnfertil Hastalarda İstmosel Tanısında Solid Embriyo Transfer Kateteri Kullanarak Salin İnfüzyon Sonografisinin Uygulanabilirliği ve Etkinliği

Sekonder İnfertil Hastalarda İstmosel Tanısında Solid Embriyo Transfer Kateteri Kullanarak Salin İnfüzyon Sonografisinin Uygulanabilirliği ve Etkinliği

Does rotation during catheter withdrawal in embryo transfer increase pregnancy rates?

The aim of this study was to determine whether there is a difference in pregnancy rates between groups that we removed directly and removed by rotating the embryo transfer catheter 360°. The study group consisted of 552 patients who were withdrawn by 360° rotation and 797 patients who were withdrawn without catheter rotation. All patients underwent one or two fresh ETs on day 3 or 5. Groups were compared in terms of cycle characteristics and clinical pregnancy rates. There were no significant differences in demographic and clinical characteristics of both groups, such as age, body mass index (BMI), duration of infertility, causes of infertility, and basal hormone levels. Clinicals pregnancy rate, in the study group, 48% (265/552) and in the control group, 50.8% (405/797) were similar in both groups. When the implantation rate and miscarriage rate were examined, both groups were found to be similar. It was found that 360° rotation while pulling catheter during embryo transfer had no effect on pregnancy and clinical pregnancy.

Quality Control of Appliance Products of Medical Devices for Human Assisted Reproductive Technology

Infertility has become one of the global problems, with the continuous improvement and penetration of human assisted reproductive technology, appliance products of medical devices for assisted reproductive technology, such as aspiration needles, micromanipulator and embryo transfer catheter, have been widely used. In order to ensure the safety and effectiveness of such products, it is necessary to establish an appropriate quality control system. This paper mainly discusses the quality control points of human assisted reproductive medical devices from the aspects of raw materials, product design, production process, key performance, packaging, preservation and transportation, so as to provide technical reference for the research and development, production and supervision of such products.

P–754 A novel warmed device protecting the embryo transfer catheter is effective in preventing the cooling of embryos during the embryo transfer procedure

Abstract Study question Can cooling of embryos during the embryo transfer be alleviated with the use of a 37 °C temperature protective device covering the ET catheter? Summary answer Cooling of embryos during embryo transfer can be effectively alleviated by using a 37 °C pre-warmed temperature protective device covering the ET catheter. What is known already An optimized physicochemical environment is crucial for maintenance of normal homeostasis, metabolism, and spindle stability to minimize stress on gametes and embryos. During preimplantation embryo development, epigenetic reprogramming occurs and environmental stress factors including temperature can disrupt this critical process and potentially damage embryos. IVF laboratories use heated stages, warming blocks and incubators to control and maintain temperature within set control limits. However, it has recently been shown that during the ET procedure, the temperature of fluid in the catheter tip drops significantly. To date no means of preventing this has been reported, or to our knowledge, implemented. Study design, size, duration In this prospective controlled study, 100 simulated embryo transfer procedures were carried out at 5 European clinics. The catheters were loaded with medium according to clinic protocol. In 50, the transfer catheter was then transported to the clinician and handled according to standard practice, and in the other 50 the catheter was covered with the temperature protecting device after loading but otherwise handled identically. 10 control and 10 intervention procedures were performed at each clinic. Participants/materials, setting, methods The temperature inside the ET catheter tip (Wallace Sure View) was measured with a calibrated thermocouple probe (diameter of 0.25 mm) placed at the location of an embryo and monitored during standard operating ET procedures (control group), and with the ET catheter-syringe set inserted into a temperature protective device (37 °C pre-warmed aluminium core, 15x90 mm) allowing retraction of the ET catheter tip immediately after embryo loading (study group). No embryos were employed in this study. Main results and the role of chance During standard operating ET procedures (control group), a considerable variation was observed in the embryo loading temperature between clinics, ranging from 34 °C to 37 °C. A profound temperature drop down to 20.8 °C–25.6 °C was recorded within 20 seconds of loading the ET catheter and in all 5 clinics a very rapid decline in catheter tip temperature down to ambient temperature was observed regardless of environment, type of workstation, or standard operating ET procedures in use. In contrast, when the ET catheter-syringe set was placed into a 37 °C pre-warmed temperature protective device from the time of embryo loading until the end of the simulated ET procedure, the drop of temperature was minimal, effectively maintaining the temperature at the loading temperature of between 34 °C and 37 °C °C throughout the simulated ET procedure. The mean loss of temperature of 14.8 °C in the control group was reduced to just to 0.4 °C in the study group. The consistent and profound differences in catheter tip temperature between the control and device groups across repeated measurements at different sites indicate the findings to be robust. Limitations, reasons for caution Numerous permutations of laboratory culture systems exist and the equipment, consumables and procedure for ET, including time, are highly variable and operator dependent. Therefore, the results and conclusions of this study may not be universally applicable. Furthermore, the impact of embryo cooling during ET on live birth rate remains uncertain. Wider implications of the findings: The ET procedure represents a ‘weak link’ in temperature control from the IVF laboratory to the patient until the embryo is safely deposited into its physiological environment, the uterine cavity. We demonstrate the effectiveness of a novel device for maintaining the temperature during ET, which could potentially improve embryo viability. Trial registration number Not applicable