Oocyte Donation

卵母细胞捐赠
  • 文章类型: Journal Article
    目标:在当代社会,社会活跃的女性越来越多地为以后的生活计划生育。高龄患者的生育结果,即使是捐卵,通常由于子宫内膜老化而不理想。复发性着床失败(RIF)是辅助生殖技术(ART)的核心问题之一。尤其是高龄患者。高品质,整倍体胚胎以及胚胎期与子宫内膜内膜之间的同步对于积极结局至关重要。该研究旨在根据具有挑战性生殖史的高龄患者的子宫内膜容受性分析(ERA),通过个性化胚胎移植(pET)改善ART结果。和RIF通过利用,供体卵母细胞和胚胎非整倍性(PGT-A)的植入前遗传测试。
    方法:随机,2020年至2023年进行了对照观察性随访研究。在获得知情同意后,选择RIF患者320例。根据随机化原则的一致应用,将患者分为研究组和对照组。对照组2单独选择。研究组包括接受PGT-A和ERA的患者,35-45岁,平均年龄为40.5±3.7岁。对照组1包括接受PGT-A的患者,35-45岁,平均年龄为40±4.2岁。对照组2包括接受PGT-A和ERA的患者,年龄小于35岁,平均年龄31.6±2.2岁。
    结果:结果表明,ERA可以改善高龄患者的植入和妊娠结局,特别是那些有RIF的。研究组妊娠率明显高于对照组(77.9%),与对照组1(57.6%)相比(p=0.0007),与对照组2(77.3%)相比无显着差异(p=0.94)。研究组的种植率(54.1%)高于对照组1(39.4%)(p=0.0009),研究组与对照2组之间无显著差异(50%,p=0.87)。研究组活产率也较高(71.3%),与对照组1相比(39.4%)(p<0.0001)。研究组与对照2组差异无统计学意义(65.9%,p=0.50)。
    结论:由ERA指导的pET可显著改善妊娠,植入,以及具有挑战性生殖史的高龄患者的活产率。在ERA指导下,pET提供的ART结局在高龄患者和年轻患者之间没有显著差异.
    OBJECTIVE: In contemporary society, socially active women are increasingly planning their fertility for later in life. The fertility outcomes for advanced-age patients, even with egg donation, are often suboptimal due to endometrial aging. Recurrent implantation failure (RIF) is one of the core problems for assisted reproductive technology (ART), especially for advanced-age patients. High-quality, euploid embryos and synchronization between the embryonic stage and the uterine endometrial lining are crucial for positive outcomes. The study aims to improve ART outcomes with personalized embryo transfer (pET) according to endometrial receptivity analysis (ERA) in advanced-age patients with challenging reproductive histories, and RIF by utilizing, donor oocytes and preimplantation genetic testing for aneuploidy (PGT-A) for embryo testing.
    METHODS: A randomized, controlled observational follow-up study was conducted from 2020 to 2023. After obtaining informed consent, 320 patients with RIF were selected. Patients were allocated into the study group and control group 1 based on consistent application of randomization principles, while control group 2 was selected separately. The study group included patients undergoing PGT-A and ERA, aged 35-45 years, with a mean age of 40.5±3.7 years. Control group 1 comprised patients undergoing PGT-A, aged 35-45 years, with a mean age of 40±4.2 years. Control group 2 consisted of patients undergoing PGT-A and ERA, aged less than 35 years, with a mean age of 31.6±2.2 years.
    RESULTS: Results suggest that ERA may improve implantation and pregnancy outcomes in advanced-age patients, particularly those with RIFs. The pregnancy rate was significantly higher in the study group (77.9%), compared to control group 1 (57.6%) (p=0.0007), and no significant difference compared to control group 2 (77.3%) (p=0.94). The implantation rate was higher in the study group (54.1%) than in control group 1 (39.4%) (p=0.0009), and there was no significant difference between the study group and control group 2 (50%, p=0.87). The live birth rate was also higher in the study group (71.3%), compared to control group 1 (39.4%) (p<0.0001). There were no significant differences between the study group and control group 2 (65.9%, p=0.50).
    CONCLUSIONS: pET guided by ERA significantly improves pregnancy, implantation, and live birth rates in advanced-age patients with challenging reproductive histories. pET provides ART outcomes with no significant difference between advanced-age patients and younger patients with pET guided by ERA.
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  • 文章类型: Journal Article
    背景:卵母细胞捐献(OD)妊娠伴随着高血压并发症的高发生率,对母亲和孩子造成严重后果。最佳护理管理,涉及早期识别,优化合适的治疗方案,并可能最终预防,需求很高。预测OD中高血压并发症的患者特异性危险因素可以为此提供依据。本项目旨在建立首个OD妊娠高血压并发症风险预测模型。
    方法:本研究是在生殖中卵母细胞的DONation项目中进行的。对于这项多中心队列研究,将招募至少541例OD妊娠。将收集基线特征和产科数据。此外,将获得一份分娩后的母体外周血和脐带血样本或儿童的唾液样本,为了确定胎儿-母体人类白细胞抗原错配的数量。收集数据后,将为二元结局高血压并发症\'是\'和\'否\'建立多变量逻辑回归模型.预测模型风险偏差评估工具将被用作指南,以最大程度地降低偏差风险。该研究将按照“个人预后或诊断多变量预测模型的透明报告”指南进行报告。将确定鉴别和校准以评估模型性能。将使用引导方法执行内部验证。外部验证将使用“生殖个体参与者数据中卵母细胞的DONation”数据集进行。
    背景:这项研究得到了医学伦理委员会LDD的批准(莱顿,DenHaag,代尔夫特),方案编号P16.048和一般评估注册(ABR)编号NL56308.058.16。进一步的结果将通过同行评审的期刊和国际会议分享。
    BACKGROUND: Oocyte donation (OD) pregnancy is accompanied by a high incidence of hypertensive complications, with serious consequences for mother and child. Optimal care management, involving early recognition, optimisation of suitable treatment options and possibly eventually also prevention, is in high demand. Prediction of patient-specific risk factors for hypertensive complications in OD can provide the basis for this. The current project aims to establish the first prediction model on the risk of hypertensive complications in OD pregnancy.
    METHODS: The present study is conducted within the DONation of Oocytes in Reproduction project. For this multicentre cohort study, at least 541 OD pregnancies will be recruited. Baseline characteristics and obstetric data will be collected. Additionally, one sample of maternal peripheral blood and umbilical cord blood after delivery or a saliva sample from the child will be obtained, in order to determine the number of fetal-maternal human leucocyte antigen mismatches. Following data collection, a multivariate logistic regression model will be developed for the binary outcome hypertensive complication \'yes\' and \'no\'. The Prediction model Risk Of Bias ASsessment Tool will be used as guide to minimise the risk of bias. The study will be reported in line with the \'Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis\' guideline. Discrimination and calibration will be determined to assess model performance. Internal validation will be performed using the bootstrapping method. External validation will be performed with the \'DONation of Oocytes in Reproduction individual participant data\' dataset.
    BACKGROUND: This study is approved by the Medical Ethics Committee LDD (Leiden, Den Haag, Delft), with protocol number P16.048 and general assessment registration (ABR) number NL56308.058.16. Further results will be shared through peer-reviewed journals and international conferences.
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  • 文章类型: Journal Article
    背景和目的:我们单中心队列研究的目的是确定子宫内灌洗粒细胞集落刺激生长因子(G-CSF)对植入失败病史超过40岁的患者临床妊娠率的影响。材料和方法:该研究于2018年5月至2020年6月在布拉格SEFerticare进行。总的来说,115名患者被分成两臂,有48名受试者在实验中,67名受试者在控制臂中。所有女性都有过不孕症治疗失败的历史,他们自己的遗传物质和至少一个无效周期与捐赠的卵母细胞。在胚胎移植前120至48小时,实验臂接受了0.5mL纯G-CSF的子宫内灌洗。结果:实验组的临床妊娠率为63.3%,对照组为47.8%(Pearsonsχ2p=0.097,Fisher精确检验p=0.133)。然而,胚胎移植当天的平均子宫内膜厚度没有统计学差异(p=0.139).只有子宫内膜厚度增长的差异有统计学意义(p=0.023)。怀孕率的提高对未来来说仍然令人鼓舞,即使它并不重要。结论:我们的研究表明,在胚胎移植前120-48小时内,宫内G-CSF灌洗后妊娠率有增加的趋势。
    Background and Objectives: The aim of our single-center cohort study was the determination of the influence of the intrauterine lavage of granulocyte colony-stimulating growth factor (G-CSF) on clinical pregnancy rate in patients with a history of implantation failure older than 40 years. Materials and Methods: The study was conducted in Ferticare Prague SE between May 2018 and June 2020. Overall, 115 patients were distributed into two arms, with 48 subjects in the experimental and 67 in the control arm. All women have had a previous history of unsuccessful history of infertility treatment with their own genetic material and at least one ineffective cycle with the donated oocytes. The experimental arm underwent the intrauterine lavage of 0.5 mL of pure G-CSF from 120 to 48 h prior to embryo transfer. Results: The clinical pregnancy rate was 63.3% in the experimental arm and 47.8% in the control arm (p = 0.097 for Pearsonߣs χ2, and p = 0.133 for Fisher\'s exact test). However, the mean endometrial thickness on the day of embryo transfer did not appear to be statistically different (p = 0.139). Only the difference in endometrium thickness growth was statistically significant (p = 0.023). The increase in pregnancy rate is still encouraging for the future, even if it is not significant. Conclusion: Our study suggests the trend of increased pregnancy rate after the intrauterine G-CSF lavage in the interval of 120-48 h prior to embryo transfer.
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  • 文章类型: Journal Article
    背景:配子和胚胎供体面临着影响其健康和生活质量的复杂挑战。医疗保健提供者需要获得结构良好、以证据为基础,以及基于需求的指导,以照顾配子和胚胎捐献者。因此,本系统综述旨在综合目前关于捐赠者管理和护理的辅助生殖指南和第三方生殖指南.
    方法:ISI的数据库,PubMed,Scopus,使用“第三方生殖”关键字搜索与辅助生殖相关的组织网站,“配子捐赠”,“胚胎捐赠”,\"指南\",“委员会意见”,和“最佳实践”,没有时间限制到2023年7月。研究中包括了以英语编写的关于配子和胚胎供体的管理和护理的所有临床或伦理指南以及最佳实践声明。使用AGREEII工具进行质量评估。审查了包含的文件,并对提取的数据进行了叙述合成。
    结果:在本系统综述中,对14个相关文件进行了综述,其中8个是指南,三个是执业守则,三个是委员会意见。在美国开发了五份文件,三个在加拿大,两个在英国,一个在澳大利亚,还有一个在澳大利亚和新西兰。此外,发现了欧洲人类生殖和胚胎学学会制定的两项指南。为捐助者提供的管理和护理分为四类,包括筛查,咨询,信息提供,和道德考虑。
    结论:虽然目前的指南包括一些关于在筛查中配子/胚胎供体的管理和护理的建议,咨询,信息提供,和道德考虑,然而,一些缺点需要解决,包括捐助者的心理社会需求,捐赠的长期影响,捐赠者的后续护理,以及捐赠的法律和人权方面。因此,需要进行强有力和精心设计的研究,以填补有关配子和胚胎供体需求的知识空白,通过制定循证指南来告知当前的做法。配子和胚胎供体面临着影响其健康和生活质量的复杂挑战。为了应对这些挑战,医疗保健提供者需要基于证据和捐赠者实际需求的指南。为了制定满足捐助者需求的全面准则;重要的是审查当前的准则。所以,在这项研究中,我们回顾了目前关于供体管理和护理的辅助生殖指南和第三方生殖指南.我们搜索了数据库和相关网站,发现了14个相关文献。这些指南中建议管理和照顾捐赠者的主要主题包括筛查,咨询,信息提供,和道德考虑。我们认识到,这些文件忽略了一些捐助者的需求,包括捐助者的社会心理需求,捐赠对捐赠者的长期影响,他们的后续关怀,以及捐赠的法律和人权方面。因此,需要进一步研究,以根据捐助者未满足的需求制定指导方针。
    BACKGROUND: Gamete and embryo donors face complex challenges affecting their health and quality of life. Healthcare providers need access to well-structured, evidence-based, and needs-based guidance to care for gamete and embryo donors. Therefore, this systematic review aimed to synthesize current assisted and third-party reproduction guidelines regarding management and care of donors.
    METHODS: The databases of ISI, PubMed, Scopus, and websites of organizations related to the assisted reproduction were searched using the keywords of \"third party reproduction\", \"gamete donation\", \"embryo donation\", \"guidelines\", \"committee opinion\", and \"best practice\", without time limit up to July 2023. All the clinical or ethical guidelines and best practice statements regarding management and care for gamete and embryo donors written in the English language were included in the study. Quality assessment was carried using AGREE II tool. Included documents were reviewed and extracted data were narratively synthesized.
    RESULTS: In this systematic review 14 related documents were reviewed of which eight were guidelines, three were practice codes and three were committee opinions. Five documents were developed in the United States, three in Canada, two in the United Kingdom, one in Australia, and one in Australia and New Zealand. Also, two guidelines developed by the European Society of Human Reproduction and Embryology were found. Management and care provided for donors were classified into four categories including screening, counseling, information provision, and ethical considerations.
    CONCLUSIONS: While the current guidelines include some recommendations regarding the management and care of gamete/embryo donors in screening, counseling, information provision, and ethical considerations, nevertheless some shortcomings need to be addressed including donors\' psychosocial needs, long-term effects of donation, donors\' follow-up cares, and legal and human rights aspects of donation. Therefore, it is needed to conduct robust and well-designed research studies to fill the knowledge gap about gamete and embryo donors\' needs, to inform current practices by developing evidence-based guidelines.
    Gamete and embryo donors face complex challenges affecting their health and quality of life. To manage these challenges, healthcare providers need guidelines that are based on evidence and donors’ real needs. In order to develop a comprehensive guideline that meets the needs of donors; it is important to review the current guidelines. So, in this study we reviewed the current assisted and third-party reproduction guidelines regarding management and care of donors. We searched databases and relevant websites and found 14 related documents. The main topics recommended for management and care of donors in these guidelines included screening, counseling, information provision, and ethical considerations. We recognized that some of donors’ needs are neglected in these documents including donors’ psychosocial needs, long-term effects of donation on donors, their follow-up cares, and legal and human rights aspects of donation. Therefore, there is need for further research to develop guidelines based on donors’ unmet needs.
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  • 文章类型: Journal Article
    本研究旨在回顾性评估辅助生殖技术(ART)治疗中原发性卵巢功能不全(POI)女性的累积生殖结局。
    本研究对139例诊断为POI的患者进行了综述。首先,根据卵母细胞来源分为两组:使用自己的卵母细胞(OG组)或接受卵母细胞捐赠(ODI组).其次,根据妊娠结局将患者分开.在OG组中,9名患者在尝试使用自己的卵母细胞失败后决定使用他人的卵母细胞,该人群是卵母细胞捐赠II组(ODII组)。
    有88名患者使用了自己的卵母细胞,而51名患者接受了卵母细胞捐赠。在OG组中,只有10名(7.2%)患者怀孕,OD组患者的激素水平更差(FSH71.37±4.18vs.43.98±2.53,AMH0.06±0.04vs.1.15±0.15,AFC0.10±0.06与1.15±0.15)和更多年的不孕症(5.04±0.48vs.3.82±0.30),这解释了为什么他们选择卵母细胞捐赠。在所有三组中,孕妇和非孕妇的基线特征具有可比性.在OG组的10名怀孕患者中,其中4人使用黄体期短效长效方案,并在第1个周期成功怀孕.
    POI女性的卵巢刺激需要更多的成本和时间。对于那些渴望拥有遗传后代的人来说,黄体期短效长效方案可以帮助他们迅速怀孕。
    UNASSIGNED: This study aims to retrospectively estimate cumulative reproductive outcomes in women with primary ovarian insufficiency (POI) in assisted reproductive technology (ART) therapy.
    UNASSIGNED: A total of 139 patients diagnosed with POI were reviewed in this study. Firstly, they were divided into two groups according to oocyte origin: using their own oocytes (OG group) or accepting oocyte donations (OD I group). Secondly, the patients were split depending on the pregnancy outcome. In the OG group, nine patients decided to use others\' oocytes after a failure of attempting to use their own, and this population was the oocyte donation II group (OD II group).
    UNASSIGNED: There were 88 patients who used their own oocytes, while 51 patients accepted oocyte donations. In the OG group, there are only 10 (7.2%) patients who got pregnant, and patients in the OD group had worse hormone levels (FSH 71.37 ± 4.18 vs. 43.98 ± 2.53, AMH 0.06 ± 0.04 vs. 1.15 ± 0.15, and AFC 0.10 ± 0.06 vs. 1.15 ± 0.15) and more years of infertility (5.04 ± 0.48 vs. 3.82 ± 0.30), which explained why they choose oocyte donation. In all the three groups, baseline characteristics were comparable between pregnant women and non-pregnant women. Of the 10 pregnant patients in the OG group, four of them used luteal-phase short-acting long protocol and had pregnancies successfully in their first cycles.
    UNASSIGNED: Ovarian stimulation in POI women requires more cost and time. For those with a stronger desire to have genetic offspring, luteal-phase short-acting long protocol may help them obtain pregnancy rapidly.
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  • 文章类型: Case Reports
    我们报道了一个年轻人的案例,免疫能力强,超声引导下经阴道取卵术(TVOR)3周后诊断为急腹症的非孕妇。腹膜液,在探查性腹腔镜检查期间获得,产生人型支原体作为唯一的病原体。患者的症状和体征在静脉注射克林霉素24小时治疗后得到改善,氨苄青霉素和庆大霉素。使用口服多西环素14天实现完全消退。
    We report the case of a young, immunocompetent, non-pregnant woman diagnosed with acute abdomen 3 weeks after an ultrasound-guided transvaginal oocyte retrieval (TVOR). Peritoneal fluid, obtained during exploratory laparoscopy, yielded Mycoplasma hominis as the sole pathogen. The patient\'s symptoms and signs improved after 24-hour treatment with intravenous clindamycin, ampicillin and gentamycin. Complete resolution was achieved with oral doxycycline for 14 days.
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  • 文章类型: Journal Article
    目的:计划行为理论(TPB)的应用是否可以帮助预测异性恋父母对子女的供养受孕?
    结论:具有较强意愿的父母按照有利于披露的社会规范行事的父母更有可能在未来5-9年内开始披露过程。
    背景:与选择单身母亲和同性伴侣相比,异性恋夫妇需要做出积极的决定,向他们的孩子披露他们对捐赠者受孕的使用。虽然国际准则鼓励早期披露,许多异性恋夫妇的父母为此而苦苦挣扎。先前的一项研究发现,父母对TPB因素的得分与披露意图之间存在关联,但到目前为止,没有研究应用TPB来预测父母的披露行为。
    方法:本研究基于全国纵向研究的第四波和第五波数据收集(T4和T5)。参与父母通过身份释放卵母细胞捐赠(n=68,应答率65%)和精子捐赠(n=62,应答率56%)作为异性恋夫妇的一部分而受孕。
    方法:本研究是瑞典配子捐赠前瞻性纵向研究(SSGD)的一部分。在3年期间(2005-2008年),在瑞典提供配子捐赠的所有七个生育诊所连续招募开始卵母细胞或精子捐赠治疗的夫妇。与会者被要求在五个时间点完成邮政调查。本研究包括在7-8岁(T4)的孩子参加的两个最新时间点的卵母细胞或精子捐赠后的异性恋夫妇父母,13-17岁(T5)。在T4时,参与者完成了针对特定研究的TPB披露问卷(TPB-DQ),以测量态度和意图向儿童披露捐赠者的概念,并在T4和T5评估披露行为。来自那些尚未在T4时披露的参与者的数据使用Cox回归的生存分析进行分析。
    结果:40名参与者在T4时没有向他们的孩子透露供体受孕,从这些中,13在T5仍未披露。我们发现T4时的TPB因子主观规范得分与T5时的后续披露行为之间存在显着关联(HR=2.019;95%CI:1.36-3.01)。其他因素均与披露行为无显著关联。
    结论:本研究涉及异性恋夫妇的父母,他们的孩子在接受开放身份捐赠者的配子治疗后受孕,这限制了我们的研究结果在其他群体和背景下的普遍性。其他限制包括由于纵向研究设计而导致系统流失的风险以及由于参与者很少而导致的统计能力下降。
    结论:我们的发现强调了感知主观规范对父母披露行为的重要性,并表明共同父母对披露行为的意见在这方面特别相关。辅导员应专注于支持准父母发起并保持健康和公开的对话,以解决有关建立具有捐助者观念的家庭的问题。
    背景:该研究由瑞典研究委员会资助。作者没有竞争利益可声明。
    背景:不适用。
    OBJECTIVE: Can the application of the theory of planned behavior (TPB) help predict heterosexual parents\' disclosure of donor conception to their children?
    CONCLUSIONS: Parents with a stronger will to act in accordance with social norms favoring disclosure were more likely to start the disclosure process within the next 5-9 years.
    BACKGROUND: In contrast to single mothers by choice and same-sex couples, heterosexual couples need to make an active decision to disclose their use of donor conception to their child. While disclosure at an early age is encouraged by international guidelines, many heterosexual-couple parents struggle with this. A previous study has found an association between parental scores of TPB factors and disclosure intention, but so far, no study has applied the TPB to predict parents\' disclosure behavior.
    METHODS: The present study is based on the fourth and fifth waves of data collection (T4 and T5) in a nation-wide longitudinal study. Participating parents had conceived through identity-release oocyte donation (n = 68, response rate 65%) and sperm donation (n = 62, response rate 56%) as part of a heterosexual couple.
    METHODS: The present study is part of the prospective longitudinal Swedish Study on Gamete Donation (SSGD). Consecutive recruitment of couples starting oocyte or sperm donation treatment was conducted at all seven fertility clinics providing gamete donation in Sweden during a 3-year period (2005-2008). Participants were requested to complete postal surveys at five time points. The present study includes heterosexual-couple parents following oocyte or sperm donation who participated at the two latest time points when their children were 7-8 years old (T4), and 13-17 years old (T5). At T4, participants completed the study-specific TPB Disclosure Questionnaire (TPB-DQ) measuring attitudes and intentions to disclose the donor conception to the child, and disclosure behavior was assessed at both T4 and T5. Data from those participants who had not yet disclosed at T4 were analyzed using survival analysis with Cox regressions.
    RESULTS: Forty participants had not disclosed the donor conception to their children at T4 and, out of these, 13 had still not disclosed at T5. We found a significant association between scores of the TPB factor Subjective norms at T4 and their subsequent disclosure behavior at T5 (HR = 2.019; 95% CI: 1.36-3.01). None of the other factors were significantly associated with disclosure behavior.
    CONCLUSIONS: The present study concerns heterosexual-couple parents with children conceived following treatment with gametes from open-identity donors, which limits the generalizability of our findings to other groups and contexts. Other limitations include the risk of systematic attrition due to the longitudinal study design and decreased statistical power due to few participants.
    CONCLUSIONS: Our findings highlight the importance of perceived subjective norms for parents\' disclosure behavior and indicate that the co-parent\'s opinion about disclosure is of particular relevance in this regard. Counselors should focus on supporting prospective parents to initiate and maintain a healthy and open dialogue about concerns around building a family with donor conception.
    BACKGROUND: The study was funded by the Swedish Research Council. The authors have no competing interests to declare.
    BACKGROUND: N/A.
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  • 文章类型: Clinical Trial Protocol
    在卵母细胞供体和不育人群中,孕酮引发的周期有效抑制了卵巢刺激期间的垂体LH激增。特别是在卵母细胞供体中,合成黄体酮(孕激素)的使用已经在前瞻性临床试验中进行了探索,显示混合结果。该试验旨在确定在卵母细胞捐赠周期中回收的成熟卵母细胞(MII)数量作为主要结果方面,使用微粉化天然孕酮是否与GnRH拮抗剂方案一样有效。它还旨在探索接受者的相应结果作为次要结果。
    我们提出了一个前瞻性的,开放标签,非劣效性临床试验,将卵母细胞供体的新方法与对照组进行比较,遵循我们机构使用的标准卵巢刺激方案。将招募总共150个供体(每组75个)并使用计算机算法随机化。在获得知情同意后,参与者将被随机分配到两种卵巢刺激方案之一:标准GnRH拮抗剂或口服微粉化天然孕酮方案.两组都将接受重组促性腺激素,根据他们的窦卵泡计数和先前的捐赠经验,如果有的话。主要结果是成熟中期II(MII)卵母细胞的数量。次要措施包括治疗持续时间,受者的妊娠结局,以及在每种治疗方案中获得的每个MII卵母细胞的经济成本。主要结果的分析将在意向治疗(ITT)和符合方案(PP)人群中进行。每个捐助者在征聘期间只能参加一次。研究的估计持续时间为6个月的主要结果和15个月的次要结果。
    该试验的结果有可能为卵母细胞供体卵巢刺激方案的管理提供循证调整。
    ClinicalTrials.gov,标识符,NCT05954962。
    UNASSIGNED: Progesterone-primed cycles effectively suppress the pituitary LH surge during ovarian stimulation in oocyte donors and in the infertile population. Particularly in oocyte donors, the use of synthetic progesterone (progestins) has been explored in prospective clinical trials, showing mixed results. This trial was designed to determine whether the use of micronized natural progesterone is as effective as the GnRH-antagonist protocol in terms of the number of mature oocytes (MII) retrieved in oocyte donation cycles as a primary outcome, and it also aims to explore the corresponding results in recipients as a secondary outcome.
    UNASSIGNED: We propose a prospective, open-label, non-inferiority clinical trial to compare a novel approach for oocyte donors with a control group, which follows the standard ovarian stimulation protocol used in our institution. A total of 150 donors (75 in each group) will be recruited and randomized using a computer algorithm. After obtaining informed consent, participants will be randomly assigned to one of two ovarian stimulation protocols: either the standard GnRH antagonist or the oral micronized natural progesterone protocol. Both groups will receive recombinant gonadotropins tailored to their antral follicle count and prior donation experiences, if any. The primary outcome is the number of mature metaphase II (MII) oocytes. Secondary measures include treatment duration, pregnancy outcomes in recipients, as well as the economic cost per MII oocyte obtained in each treatment regimen. Analyses for the primary outcome will be conducted in both the intention-to-treat (ITT) and per-protocol (PP) populations. Each donor can participate only once during the recruitment period. The estimated duration of the study is six months for the primary outcome and 15 months for the secondary outcomes.
    UNASSIGNED: The outcomes of this trial have the potential to inform evidence-based adjustments in the management of ovarian stimulation protocols for oocyte donors.
    UNASSIGNED: ClinicalTrials.gov, identifier, NCT05954962.
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  • 文章类型: Journal Article
    目的:分析年龄在40至45岁之间的妇女在体外受精或卵母细胞捐献后分娩的围产期和产妇结局,与自发的概念相比。
    方法:这项回顾性队列研究使用了2000年至2019年国家医疗保健服务的电子数据。比较三组:自发性妊娠(SC),利用自体卵母细胞的体外受精(IVF),和卵母细胞捐赠(OD)导致的怀孕。主要研究结果是妊娠37周前早产(PTL),和分类为小于胎龄(SGA)的婴儿。
    结果:该队列包括26,379SC,2237例IVF怀孕,和300OD怀孕40-45岁的妇女在分娩时。与SC的女性相比,OD或IVF的女性PTL<37周的发生率更高(19.7%vs.18%vs.6.9%,p=0.001),PTL<34(7%vs.4.5%与1.4%,p=0.001),PTL<32(3.7vs.2.1vs.0.6,p=0.001)。PTL<37周的多因素logistic回归分析显示,年龄(OR=1.18)和高血压疾病(OR=3.4)是有统计学意义的因素。与SC相比,OD组的SGA发生率较低(1%vs.4.3%,p=0.001),而IVF组的SGA率高于SC(9.1%vs.4.3%,p=0.001)。与SP妊娠相比,OD组和IVF组的妊娠高血压疾病明显高于SP妊娠(3.3%vs.1%,p=0.002;2.3%vs.1%,分别为p=0.001)。
    结论:接受IVF或OD的40-45岁女性患PTL的风险更大,可能是由于妊娠高血压疾病的发生率较高。
    OBJECTIVE: To analyze the perinatal and maternal outcomes of women ranging in age from 40 to 45 years who gave birth after in vitro fertilization or oocyte donation, compared to spontaneous conception.
    METHODS: This retrospective cohort study used electronic data from a national healthcare service from 2000 through 2019. Three groups were compared: spontaneous pregnancy (SC), in vitro fertilization (IVF) utilizing autologous oocytes, and pregnancies resulting from oocyte donation (OD). The primary study outcomes were preterm labor (PTL) before 37 weeks of gestation, and infants classified as small for gestational age (SGA).
    RESULTS: The cohort included 26,379 SC, 2237 IVF pregnancies, and 300 OD pregnancies for women ages 40-45 years at delivery. Women with OD or IVF had a higher incidence of PTL < 37 weeks compared to women with SC (19.7% vs. 18% vs. 6.9%, p = 0.001), PTL < 34 (7% vs. 4.5% vs. 1.4%, p = 0.001), PTL < 32 (3.7 vs. 2.1 vs. 0.6, p = 0.001). A multivariable logistic regression for PTL < 37 weeks demonstrated that age (OR = 1.18) and hypertensive diseases (OR = 3.4) were statistically significant factors. The OD group had a lower rate of SGA compared to SC (1% vs. 4.3%, p = 0.001), while the IVF group had a higher rate of SGA compared to SC (9.1% vs. 4.3%, p = 0.001). Hypertensive diseases in pregnancy were significantly higher among the OD group and the IVF group compared to SP pregnancies (3.3% vs. 1%, p = 0.002; 2.3% vs. 1%, p = 0.001, respectively).
    CONCLUSIONS: Women ages 40-45 undergoing IVF or OD have a greater risk of PTL, possibly due to higher rates of hypertensive disorders of pregnancy.
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  • 文章类型: Journal Article
    目的:研究青年社区剥夺指数(NDI)和卵巢储备指标与控制性卵巢刺激结局的关系,健康的卵母细胞捐献者。
    方法:回顾性队列研究受试者:在桑迪斯普林斯的一家私人生育中心,547名卵母细胞捐献者接受了905个卵母细胞提取周期(2008-2020),格鲁吉亚,美国。
    方法:NDI是使用主成分分析计算的,主成分分析应用于人口普查水平的贫困指标,employment,家庭组成,公共援助,然后将其标准化并与基于捐赠者居住地的捐赠者信息相关联。
    方法:卵巢储备标志物,包括窦卵泡计数(AFC)和抗苗勒管激素(AMH)水平,和控制性卵巢刺激的结果,包括检索到的卵母细胞总数和成熟卵母细胞数以及卵巢敏感性指数(OSI)(定义为检索到的卵母细胞数÷总促性腺激素剂量×1,000)。使用具有泊松和正态分布的多变量广义估计方程来建模NDI与调整年龄的结果指标之间的关系,BMI,和检索年份。
    结果:捐献者的平均(标准差)年龄为25.0(2.8)岁,29%的捐献者是种族/少数民族。供体NDI和卵巢储备标志物之间没有关联。NDI每增加四分位数间距,尽管效应估计不精确,但回收的总卵母细胞减少了-1.5%(95%CI-5.3,2.4%).NDI与回收的成熟卵母细胞数量和OSI的关联方向相似。我们观察到供体种族对NDI和OSI关联的影响改变的证据。在黑人捐赠者中,NDI和OSI之间存在暗示性正相关,但在白人捐赠者中没有关联。
    结论:在这群年轻人中,健康,种族不同的卵母细胞捐赠者,我们发现几乎没有证据表明NDI与卵巢储备标志物或卵巢刺激结局之间存在关联.
    OBJECTIVE: To study the relationship between neighborhood deprivation index (NDI) and markers of ovarian reserve and outcomes of controlled ovarian stimulation among young, healthy oocyte donors.
    METHODS: Retrospective cohort study.
    METHODS: A total of 547 oocyte donors who underwent 905 oocyte retrieval cycles (2008-2020) at a private fertility center in Sandy Springs, Georgia, United States.
    METHODS: Neighborhood deprivation index was calculated using principal component analysis applied to census-level measures of poverty, employment, household composition, and public assistance, which was then standardized and linked to donor information on the basis of donor residence.
    METHODS: Markers of ovarian reserve, including antral follicle count (AFC) and antimüllerian hormone (AMH) levels, and outcomes of controlled ovarian stimulation including number of total and mature oocytes retrieved and ovarian sensitivity index (OSI) (defined as the number of oocytes retrieved/total gonadotropin dose × 1,000). Multivariable generalized estimating equations with Poisson and normal distribution were used to model the relationship between NDI and outcome measures adjusting for age, body mass index, and year of retrieval.
    RESULTS: The mean (SD) age of donors was 25.0 (2.8) years and 29% of the donors were racial or ethnic minorities. There were no associations between donor NDI and ovarian reserve markers. For every interquartile range increase in NDI, there was a reduction of -1.5% (95% confidence interval: -5.3% to 2.4%) in total oocytes retrieved although the effect estimate was imprecise. Associations of NDI with a number of mature oocytes retrieved and OSI were in a similar direction. We observed evidence for effect modification of the NDI and OSI association by donor race. There was a suggestive positive association between NDI and OSI in Black donors but no association in White donors.
    CONCLUSIONS: In this cohort of young, healthy, racially diverse oocyte donors, we found little evidence of associations between NDI and markers of ovarian reserve or outcomes of ovarian stimulation.
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