scholarly journals ICSI does not improve reproductive outcomes in autologous ovarian response cycles with non-male factor subfertility

2020 ◽  
Vol 35 (3) ◽  
pp. 583-594 ◽  
Author(s):  
P R Supramaniam ◽  
I Granne ◽  
E O Ohuma ◽  
L N Lim ◽  
E McVeigh ◽  
...  
Keyword(s):  
Treatment Cycle ◽  
Ovarian Response ◽  
Advisory Board ◽  
Clinical Pregnancy ◽  
The European Union ◽  
Reproductive Outcomes ◽  
Male Factor ◽  
Research Grants ◽  
Fertilisation Rate ◽  
The Uk

Abstract STUDY QUESTION Does the method of fertilisation improve reproductive outcomes in poor ovarian response (POR) cycles when compared to all other ovarian response categories in the absence of male factor subfertility? SUMMARY ANSWER ICSI does not confer any benefit in improving the clinical pregnancy or live birth (LB) outcome in autologous ovarian response cycles in the absence of male factor subfertility when compared to IVF. WHAT IS KNOWN ALREADY ICSI is associated with an improved outcome when compared to IVF in patients with severe male factor subfertility. STUDY DESIGN, SIZE, DURATION A retrospective study involving 1 376 454 ART cycles, of which 569 605 (41.4%) cycles fulfilled the inclusion and exclusion criteria for all autologous ovarian response categories: 272 433 (47.8%) IVF cycles and 297 172 (52.2%) ICSI cycles. Of these, the POR cohort represented 62 641 stimulated fresh cycles (11.0%): 33 436 (53.4%) IVF cycles and 29 205 (46.6%) ICSI cycles. PARTICIPANTS/MATERIALS, SETTING, METHOD All cycles recorded on the anonymised Human Fertilisation and Embryology Authority (HFEA) registry database between 1991 and 2016 were analysed. All fresh cycles with normal sperm parameters, performed after 1998 were included: frozen cycles, donor oocyte and sperm usage, intrauterine insemination cycles, preimplantation genetic testing (PGT) for aneuploidies (PGT-A), PGT for monogenic/single gene defects (PGT-M), PGT for chromosomal structural arrangements (PGT-SR) cycles, where the reason for stimulation was for storage and unstimulated cycles were excluded. MAIN RESULTS AND THE ROLE OF CHANCE ICSI did not confer any benefit in improving the LB outcome when compared to conventional IVF per treatment cycle (PTC), when adjusted for female age, number of previous ART treatment cycles, number of previous live births through ART, oocyte yield, stage of transfer, method of fertilisation and number of embryos transferred in the POR cohort (adjusted odds ratio [a OR] 1.03, 99.5% confidence interval [CI] 0.96–1.11, P = 0.261) and all autologous ovarian response categories (aOR 1.00, 99.5% CI 0.98–1.02, P = 0.900). The mean fertilisation rate was statistically lower for IVF treatment cycles (64.7%) when compared to ICSI treatment cycles (67.2%) in the POR cohort (mean difference −2.5%, 99.5% CI −3.3 to −1.6, P < 0.001). The failed fertilisation rate was marginally higher in IVF treatment cycles (17.3%, 95% binomial exact 16.9 to 17.7%) when compared to ICSI treatment cycles (17.0%, 95% binomial exact 16.6 to 17.4%); however, this did not reach statistical significance (P = 0.199). The results followed a similar trend when analysed for all autologous ovarian response categories with a higher rate of failed fertilisation in IVF treatment cycles (4.8%, 95% binomial exact 4.7 to 4.9%) when compared to ICSI treatment cycles (3.2%, 95% binomial exact 3.1 to 3.3%) (P < 0.001). LIMITATIONS, REASONS FOR CAUTION The quality of data is reliant on the reporting system. Furthermore, success rates through ART have improved since 1991, with an increased number of blastocyst-stage embryo transfers. The inability to link the treatment cycle to the individual patient meant that we were unable to calculate the cumulative LB outcome per patient. WIDER IMPLICATIONS OF THE FINDINGS This is the largest study to date which evaluates the impact of method of fertilisation in the POR patient and compares this to all autologous ovarian response categories. The results demonstrate that ICSI does not confer any benefit in improving reproductive outcomes in the absence of male factor subfertility, with no improvement seen in the clinical pregnancy or LB outcomes following a fresh treatment cycle. STUDY FUNDING/COMPETING INTEREST(S) The study received no funding. C.M.B. is a member of the independent data monitoring group for a clinical endometriosis trial by ObsEva. He is on the scientific advisory board for Myovant and medical advisory board for Flo Health. He has received research grants from Bayer AG, MDNA Life Sciences, Volition Rx and Roche Diagnostics as well as from Wellbeing of Women, Medical Research Council UK, the NIH, the UK National Institute for Health Research and the European Union. He is the current Chair of the Endometriosis Guideline Development Group for ESHRE and was a co-opted member of the Endometriosis Guideline Group by the UK National Institute for Health and Care Excellence (NICE). I.G. has received research grants from Bayer AG, Wellbeing of Women, the European Union and Finox. TRIAL REGISTRATION NUMBER Not applicable.

scholarly journals Secondary sex ratio in assisted reproduction: an analysis of 1 376 454 treatment cycles performed in the UK

2019 ◽  
Vol 2019 (4) ◽  
Author(s):  
P R Supramaniam ◽  
M Mittal ◽  
E O Ohuma ◽  
L N Lim ◽  
E McVeigh ◽  
...  
Keyword(s):  
Birth Rate ◽  
Live Birth Rate ◽  
Blastocyst Stage ◽  
Advisory Board ◽  
The European Union ◽  
Research Grants ◽  
Secondary Sex Ratio ◽  
Stage Embryo ◽  
Natural Conception ◽  
The Uk

Abstract STUDY QUESTION Does ART impact the secondary sex ratio (SSR) when compared to natural conception? SUMMARY ANSWER IVF and ICSI as well as the stage of embryo transfer does impact the overall SSR. WHAT IS KNOWN ALREADY The World Health Organization quotes SSR for natural conception to range between 103 and 110 males per 100 female births. STUDY DESIGN, SIZE, DURATION A total of 1 376 454 ART cycles were identified, of which 1 002 698 (72.8%) cycles involved IVF or ICSI. Of these, 863 859 (85.2%) were fresh cycles and 124 654 (12.4%) were frozen cycles. Missing data were identified in 14 185 (1.4%) cycles. PARTICIPANTS/MATERIALS, SETTING, METHODS All cycles recorded in the anonymized UK Human Fertilisation and Embryology Authority (HFEA) registry database between 1991 and 2016 were analysed. All singleton live births were included, and multiple births were excluded to avoid duplication. MAIN RESULTS AND THE ROLE OF CHANCE The overall live birth rate per cycle for all IVF and ICSI treatments was 26.2% (n = 262 961), and the singleton live birth rate per cycle was 17.1% (n = 171 399). The overall SSR for this study was 104.0 males per 100 female births (binomial exact 95% CI: 103.1–105.0) for all IVF and ICSI cycles performed in the UK recorded through the HFEA. This was comparable to the overall SSR for England and Wales at 105.3 males per 100 female births (95% CI: 105.2–105.4) from 1991 to 2016 obtained from the Office of National Statistics database. Male predominance was seen with conventional insemination in fresh IVF treatment cycles (SSR 110.0 males per 100 female births; 95% CI: 108.6–111.5) when compared to micro-injection in fresh ICSI treatment cycles (SSR 97.8 males per 100 female births; 95% CI: 96.5–99.2; odds ratio (OR) 1.16, 95% CI 1.12–1.19, P < 0.0001), as well as with blastocyst stage embryo transfers (SSR 104.8 males per 100 female births; 95% CI: 103.5–106.2) when compared to a cleavage stage embryo transfer (SSR 101.2 males per 100 female births; 95% CI: 99.3–103.1; OR 1.03, 95% CI 1.01–1.06, P = 0.011) for all fertilization methods. LIMITATIONS, REASONS FOR CAUTION The quality of the data relies on the reporting system. Furthermore, success rates through ART have improved since 1991, with an increased number of blastocyst stage embryo transfers. WIDER IMPLICATIONS OF THE FINDINGS This is the largest study to date evaluating the impact of ART on SSR. The results demonstrate that, overall, ART does have an impact on the SSR when assessed according to the method of fertilization (ICSI increased female births while IVF increased males). However, given the ratio of IVF to ICSI cycles at present with 60% of cycles from IVF and 40% from ICSI, the overall SSR for ART closely reflects the population SSR for, largely, natural conceptions in England and Wales. STUDY FUNDING/COMPETING INTEREST(S) The study received no funding. C.M.B. is a member of the independent data monitoring group for a clinical endometriosis trial by ObsEva. He is on the scientific advisory board for Myovant and medical advisory board for Flo Health. He has received research grants from Bayer AG, MDNA Life Sciences, Volition Rx and Roche Diagnostics as well as from Wellbeing of Women, Medical Research Council UK, the NIH, the UK National Institute for Health Research and the European Union. He is the current Chair of the Endometriosis Guideline Development Group for ESHRE and was a co-opted member of the Endometriosis Guideline Group by the UK National Institute for Health and Care Excellence (NICE). I.G. has received research grants from Wellbeing of Women, the European Union and Finox. TRIAL REGISTRATION NUMBER Not applicable.

The Law & Politics of Brexit: Volume II

2020 ◽  
Keyword(s):  
Decision Making ◽  
European Union ◽  
Legal Framework ◽  
Comprehensive Analysis ◽  
The European Union ◽  
Trade Relations ◽  
The United Kingdom ◽  
The Uk ◽  
Financial Settlement ◽  
The Eu

This book provides the first comprehensive analysis of the withdrawal agreement concluded between the United Kingdom and the European Union to create the legal framework for Brexit. Building on a prior volume, it overviews the process of Brexit negotiations that took place between the UK and the EU from 2017 to 2019. It also examines the key provisions of the Brexit deal, including the protection of citizens’ rights, the Irish border, and the financial settlement. Moreover, the book assesses the governance provisions on transition, decision-making and adjudication, and the prospects for future EU–UK trade relations. Finally, it reflects on the longer-term challenges that the implementation of the 2016 Brexit referendum poses for the UK territorial system, for British–Irish relations, as well as for the future of the EU beyond Brexit.

Men's perception and understanding of male-factor infertility in the UK

2021 ◽  
Vol 30 (9) ◽  
pp. S8-S16
Author(s):  
Eleanor L Stevenson ◽  
Cheng Ching-Yu ◽  
Chang Chia-Hao ◽  
Kevin R McEleny
Keyword(s):  
Public Health ◽  
Emotional Support ◽  
Health Professionals ◽  
Male Fertility ◽  
Public Knowledge ◽  
Evidence Based ◽  
Male Factor Infertility ◽  
Male Factor ◽  
The Public ◽  
The Uk

Male-factor infertility is a common but stigmatised issue, and men often do not receive the emotional support and the information they need. This study sought to understand awareness of male fertility issues compared to female fertility among the UK general male public, and also what were perceived as being the optimum methods for providing support for affected men, emotionally and through information. Men feel that male infertility is not discussed by the public as much as female infertility. Lifestyle issues that affect male fertility are not well understood, and men affected by infertility desire more support, including online, from health professionals and through peer support. Health professionals, including those in public health, could offer evidence-based programmes to reduce stigma and increase public knowledge about infertility, as well as offer emotional support to men with infertility problems.

scholarly journals Controlled ovarian stimulation should not be preferred for male infertility treated with intrauterine insemination: a retrospective study

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Yan Tang ◽  
Qian-Dong He ◽  
Ting-Ting Zhang ◽  
Jing-Jing Wang ◽  
Si-Chong Huang ◽  
...  
Keyword(s):  
Ectopic Pregnancy ◽  
Pregnancy Rate ◽  
Ovarian Stimulation ◽  
Intrauterine Insemination ◽  
Multiple Pregnancy ◽  
Clinical Pregnancy ◽  
Male Factor Infertility ◽  
Male Factor ◽  
Ovulatory Follicles ◽  
Multiple Pregnancy Rate

Abstract Background Some studies have stated that intrauterine insemination (IUI) with controlled ovarian stimulation (COS) might increase the pregnancy rate, while others suggest that IUI in the natural cycle (NC) should be the first line of treatment. It remains unclear whether it is necessary to use COS at the same time when IUI is applied to treat isolated male factor infertility. Thus, we aimed to investigate efficacy of IUI with COS for isolated male factor infertility. Methods A total of 601 IUI cycles from 307 couples who sought medical care for isolated male factor infertility between January 2010 and February 2020 were divided into two groups: NC-IUI and COS-IUI. The COS-IUI group was further divided into two subgroups according to the number of pre-ovulatory follicles on the day of HCG: cycles with monofollicular development (one follicle group) and cycles with at least two pre-ovulatory follicles (≥ 2 follicles group). The IUI outcomes, including clinical pregnancy, live birth, spontaneous abortion, ectopic pregnancy, and multiple pregnancy rates were compared. Results The clinical pregnancy, live birth, spontaneous abortion, and ectopic pregnancy rates were comparable between the NC-IUI and COS-IUI group. Similar results were also observed among the NC-IUI, one follicle, and ≥ 2 follicles groups. However, with respect to the multiple pregnancy rate, a trend toward higher multiple pregnancy rate was observed in the COS-IUI group compared to the NC-IUI group (8.7% vs. 0, P = 0.091), and a significant difference was found between the NC-IUI and ≥ 2 follicles group (0 vs. 16.7%, P = 0.033). Conclusion In COS cycles, especially in those with at least two pre-ovulatory follicles, the multiple pregnancy rate increased without a substantial gain in overall pregnancy rate; thus, COS should not be preferred in IUI for isolated male factor infertility. If COS is required, one stimulated follicle and one healthy baby should be the goal considering the safety of both mothers and foetuses.

scholarly journals The value of serum progesterone level on day of human chorionic gonadotrophin administration / metaphase II oocyte ratio in predicting IVF/ICSI outcome in patients with normal ovarian reserve

2021 ◽  
Vol 14 (1) ◽  
Author(s):  
Ahmad Mahran ◽  
Mohammed Khairy ◽  
Reham Elkhateeb ◽  
Abdel Rahman Hegazy ◽  
Ayman Abdelmeged ◽  
...  
Keyword(s):  
Sensitivity And Specificity ◽  
Ovarian Response ◽  
Pregnancy Rates ◽  
Clinical Pregnancy ◽  
Progesterone Level ◽  
Receiver Operating Curve ◽  
Serum Progesterone ◽  
Predictive Values ◽  
Significant Difference ◽  
Assisted Reproduction Treatment

Abstract Background The clinical implication of the increased serum progesterone level on the day of HCG administration in assisted reproduction treatment (ART) is still controversial. The current study aimed to compare the predictive value of serum progesterone on day of HCG administration / metaphase II oocyte (P/MII) ratio on IVF/ ICSI outcome to serum progesterone (P) level alone and the ratio of serum progesterone/estradiol level (P/E2) ratio in prediction of pregnancy rates after ART. Material & methods Two hundred patients admitted to the IVF/ICSI program at Minia IVF center in Egypt in the period from October 2016 to May 2018 were included in this study. Serum Progesterone (P) and Estradiol (E2) levels were estimated on the day of HCG administration. The ratio between serum P and the number of MII oocytes (P/MII ratio) was calculated and the predictive values of the three parameters (P, P/E2 ratio and P/MII ratio) in prediction of cycle outcomes were measured. Results P/ MII oocyte ratio was significantly lower in patients who attained clinical pregnancy (n = 97) as compared with those who couldn’t whilst there was no significant difference in P and P/E2 ratio between the two groups. Using a cut off value of 0.125, the sensitivity and specificity of progesterone/ MII ratio in prediction of no pregnancy in IVF/ICSI were 75.7 and 77.1% respectively with the area under The Receiver operating curve (ROC-AUC) = 0.808. The respective values of the ROC-AUC for the P and P/E2 ratio were 0.651 and 0.712 with sensitivity and specificity of 71.2 and 73.5%for P level and of 72.5 and 75.3% for P/E2 ratio. Implantation or clinical pregnancy rates were significantly different between patients with high and low P/MII ratio irrespective of day of embryo transfer (day 3 or 5). Conclusions In patients with normal ovarian response, serum progesterone on day of HCG / MII oocyte ratio can be a useful predictor of pregnancy outcomes and in deciding on freezing of all embryos for later transfer instead of high progesterone level alone.

scholarly journals In vitro fertilisation (IVF) versus intracytoplasmic sperm injection (ICSI) in patients without severe male factor infertility: study protocol for the randomised, controlled, multicentre trial INVICSI

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e051058
Author(s):  
Sine Berntsen ◽  
Bugge Nøhr ◽  
Marie Louise Grøndahl ◽  
Morten Rønn Petersen ◽  
Lars Franch Andersen ◽  
...  
Keyword(s):  
Live Birth ◽  
Intracytoplasmic Sperm Injection ◽  
Controlled Trial ◽  
Male Partner ◽  
In Vitro Fertilisation ◽  
Male Factor Infertility ◽  
Male Factor ◽  
Fertilisation Rate ◽  
Randomised Controlled

IntroductionOver the last decades, the use of intracytoplasmic sperm injection (ICSI) has increased, even among patients without male factor infertility. The increase has happened even though there is no evidence to support that ICSI results in higher live birth rates compared with conventional in vitro fertilisation (IVF) in cases with nonmale factor infertility. The lack of robust evidence on an advantage of using ICSI over conventional IVF in these patients is problematic since ICSI is more invasive, complex and requires additional resources, time and effort. Therefore, the primary objective of the IVF versus ICSI (INVICSI) study is to determine whether ICSI is superior to standard IVF in patients without severe male factor infertility. The primary outcome measure is first live birth from fresh and frozen-thawed transfers after one stimulated cycle. Secondary outcomes include fertilisation rate, ongoing pregnancy rate, birth weight and congenital anomalies.Methods and analysisThis is a two-armed, multicentre, randomised, controlled trial. In total, 824 couples/women with infertility without severe male factor will be recruited and allocated randomly into two groups (IVF or ICSI) in a 1:1 ratio. Participants will be randomised in variable block sizes and stratified by trial site and age. The main inclusion criteria are (1) no prior IVF/ICSI treatment, (2) male partner sperm with an expected count of minimum 2 million progressive motile spermatozoa following density gradient purification on the day of oocyte pick up and (3) age of the woman between 18 and 42 years.Ethics and disseminationThe study will be performed in accordance with the ethical principles in the Helsinki Declaration. The study is approved by the Scientific Ethical Committee of the Capital Region of Denmark. Study findings will be presented, irrespectively of results at international conferences and submitted for publication in peer-reviewed journals.Trial registration numberNCT04128904. Pre-results.

scholarly journals Advancing UK Regulatory Science Strategy in the Context of Global Regulation: a Stakeholder Survey

2021 ◽  
Author(s):  
Samantha Cruz Rivera ◽  
Barbara Torlinska ◽  
Eliot Marston ◽  
Alastair K. Denniston ◽  
Kathy Oliver ◽  
...  
Keyword(s):  
Pay For Performance ◽  
Regulatory Science ◽  
International Strategy ◽  
Free Text ◽  
The European Union ◽  
Accurate Definition ◽  
Definition Of ◽  
Healthcare Innovation ◽  
The Uk ◽  
Medium Enterprises

Abstract Background The UK’s transition from the European Union creates both an urgent need and key opportunity for the UK and its global collaborators to consider new approaches to the regulation of emerging technologies, underpinned by regulatory science. This survey aimed to identify the most accurate definition of regulatory science, to define strategic areas of the regulation of healthcare innovation which can be informed through regulatory science and to explore the training and infrastructure needed to advance UK and international regulatory science. Methods A survey was distributed to UK healthcare professionals, academics, patients, health technology assessment agencies, ethicists and trade associations, as well as international regulators, pharmaceutical companies and small or medium enterprises which have expertise in regulatory science and in developing or applying regulation in healthcare. Subsequently, a descriptive quantitative analyses of survey results and directed thematic analysis of free-text comments were applied. Results Priority areas for UK regulatory science identified by 145 participants included the following: flexibility: the capability of regulations to adapt to novel products and target patient outcomes; co-development: collaboration across sectors, e.g. patients, manufacturers, regulators, and educators working together to develop appropriate training for novel product deployment; responsiveness: the preparation of frameworks which enable timely innovation required by emerging events; speed: the rate at which new products can reach the market; reimbursement: developing effective tools to track and evaluate outcomes for “pay for performance” products; and education and professional development. Conclusions The UK has a time-critical opportunity to establish its national and international strategy for regulatory science leadership by harnessing broader academic input, developing strategic cross-sector collaborations, incorporating patients’ experiences and perspectives, and investing in a skilled workforce.

scholarly journals “East” in Europe—Health Dimension through the Lens of the UK Daily Mail and Statistical Facts

2021 ◽  
Vol 18 (7) ◽  
pp. 3705
Author(s):  
Izabella Lecka ◽  
Viktoriya Pantyley ◽  
Liudmila Fakeyeva ◽  
Alexandrina Cruceanu
Keyword(s):  
Care Practice ◽  
The European Union ◽  
Daily Mail ◽  
Media Criticism ◽  
The United Kingdom ◽  
Health Dimension ◽  
European Immigrants ◽  
The Uk ◽  
Zero Sum ◽  
Eastern European Immigrants

The study concerns the relationship between health and geopolitics in the United Kingdom (UK). To demonstrate this relationship, we examined the subject and tone of articles published in the popular media (on the example of tabloid the Daily Mail) in 2006–2020 concerning health and medical care, and the health and health care practice of Eastern European immigrants belonging to and not belonging to the European Union (EU). There was an increase in media criticism of the behaviour of immigrants in the years 2014–2017, in the period around the referendum in favour of the UK leaving the EU (Brexit). Attention was drawn to the media’s use of a Belief in a Zero-Sum Game (BZSG) narrative at that time. On both sides, “hosts” and the “guests”, a progressive anomy process was observed, degrading the behaviour of individuals and social groups.

scholarly journals Comparison of the predictive value of progesterone‐related indicators for pregnancy outcomes of women undergoing the short‐acting GnRH agonist long protocol: a retrospective study

2021 ◽  
Vol 14 (1) ◽  
Author(s):  
Yangyang Zhang ◽  
Yang Xu ◽  
Yuqiong Wang ◽  
Qing Xue ◽  
Jing Shang ◽  
...  
Keyword(s):  
Pregnant Women ◽  
Gnrh Agonist ◽  
Pregnancy Outcomes ◽  
Predictive Value ◽  
Ovarian Response ◽  
Clinical Pregnancy ◽  
Short Acting ◽  
Good Quality Embryo ◽  
Response Group ◽  
Long Protocol

Abstract Background There are many progesterone (P) elevation-related indicators for predicting pregnancy outcomes, including the serum P, P-to-oestradiol ratio (P/E2), P-to-follicle index (PFI), and P-to-mature oocyte index (PMOI); however, due to inconsistencies in study populations and controlled ovarian hyperstimulation (COH) protocols among studies, these indicators are controversial. Moreover, no researchers have included these four commonly used indicators in one study to compare their predictive efficacies. The objective of this study was to compare the predictive value of P-related indicators for pregnancy outcomes of women undergoing the short-acting GnRH agonist long protocol. Methods A total of 612 infertile women undergoing IVF/ICSI were recruited for this study. Serum samples were obtained on the morning of HCG injection for serum P and E2 measurements. Transvaginal ultrasound was performed to determine the follicle count (≥ 14 mm in diameter). The number of mature oocytes was observed in the embryo laboratory after oocyte retrieval. Results In cases of P < 2.5 ng/ml, there was no significant difference in the serum P level or P/E2 between the pregnant group and the non-pregnant group. The PFI and PMOI of the pregnant group were significantly lower than those of the non-pregnant group. According to the stratified analysis of the ovarian response, only the PMI and PMOI of the pregnant women in the normal ovarian response group were lower than those of the non-pregnant women. To compare the predictive value of the PFI and PMOI in IVF/ICSI outcomes, the patients were divided into four groups. The good-quality embryo rate and clinical pregnancy rate were highest in Group A (low PFI and low PMOI) and lowest in Group D (high PFI and high PMOI). In the two groups with discordant PFI and PMOI, namely Group B (low PFI and high PMOI) and Group C (high PFI and low PMOI), the good-quality embryo rate and clinical pregnancy rate were not significantly different. Conclusions The PFI and PMOI had equal value in predicting clinical pregnancy outcomes in the normal ovarian response group undergoing the short-acting GnRH agonist long protocol. Each clinical centre can choose one of the indicators according to their actual situation in clinical practice and establish individual cut-off values for PFI and PMOI based on their own hormonal measurements.

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