目的:在卵巢储备功能低下(POR)患者中,卵巢内注射富血小板血浆(PRP)是否会增加连续卵巢穿刺取卵的数量?
结论:注射PRP会增加取卵的数量,而不会增加发育胚泡的质量。
背景:治疗卵巢对刺激反应降低的女性是生殖医学的重大挑战之一。最近,PRP治疗已被提议作为辅助生殖技术的辅助手段,有争议的结果。
方法:这种安慰剂对照,双盲,根据POSEIDON分类第3组和第4组,纳入了60例POR患者的随机试验.探讨卵巢内注射PRP的有效性和安全性。建议患者连续进行三次卵巢刺激以积累卵母细胞,并在首次取卵期间随机接受PRP或安慰剂。使用计算机生成的随机化代码进行随机化。确保双盲,以使参与者和研究人员都不知道分配的治疗。所有患者都接受了三次卵巢刺激和取卵程序。在第三次卵巢穿刺后进行ICSI。主要终点是连续卵巢穿刺注射PRP或安慰剂后回收的成熟卵母细胞数量。
方法:将符合纳入标准的60名妇女(30-42岁)以相同比例随机分配到治疗组或对照组。
结果:基线人口统计学和临床特征[年龄,BMI,抗苗勒管激素(AMH)水平]组间比较.关于主要端点,治疗组中回收的成熟卵母细胞的累积数量(平均值±SEM)略高:10.45±0.41,而对照组为8.91±0.39,分别(差异的95%CI为0.42-2.66;P=0.008)。在所有患者中获得的成熟卵母细胞的数量在连续的卵子回收中增加:1号(P1)中的2.61±0.33(平均值±SEM),P2为3.85±0.42,P3为4.73±0.44。然而,在接受评估的PRP治疗的患者中,这一增幅更高.在P2中,回收的成熟卵母细胞数量为4.18±0.58,而对照组为3.27±0.61(差异的95%CI:-0.30至2.12;P=0.138),在P3中,为5.27±0.73,而4.15±0.45(差异的95%CI:0.12-2.12;P=0.029)。对照组的显影和活检囊胚的平均±SEM数量为2.43±0.60,治疗组为1.90±0.32,分别为(P=0.449)。对照组和治疗组的平均整倍体囊胚数为0.81±0.24,0.81±0.25,分别为(P=1.000)。对照组和治疗组患者的整倍体囊胚比例分别为53.33%(30人中有16人)和43.33%(30人中有13人),分别(Fisher精确检验P=0.606)。每个ITT的总体妊娠率为43%(60例患者中有26例)。然而,对照组的临床妊娠百分比(30中的18例,60%)高于治疗组(30中的8例,27%)(P=0.018).当考虑足月妊娠时,治疗组的结局也有较差的趋势(P=0.170)。在分娩类型方面,对照组和治疗组之间没有差异。和新生儿的性别。
结论:注射PRP对回收的卵母细胞数量的潜在有益作用的机制尚不清楚。可能涉及递送的血小板因子或机械效应。需要进一步的研究来确认或反驳本试验中提供的数据,并确定确切的作用机制。如果有的话,PRP的准备工作。
结论:越来越多的对卵巢刺激反应较差的女性支持探索新的研究领域,以了解能够增加可用于受精的卵母细胞数量和提高发育胚泡质量的治疗方法的潜在益处。在试验的两个臂中回收的卵母细胞的增加表明,除了从血小板中释放生长因子,机械效应可以发挥作用。然而,未发现整倍体囊胚发育和妊娠率的改善.
背景:该试验得到了巴斯克政府的支持,并纳入了HAZITEK计划,在新的Euskadi2030科学和技术计划(PCTI2030)框架内。这些援助由欧洲区域发展基金(FEDER)共同资助。研究资助者在研究设计中没有任何作用,实施,分析,手稿准备,或决定提交这篇文章发表。所有作者都不宣布任何竞争利益。
背景:临床试验编号EudraCT2020-000247-32。
■2020年11月3日。
■2021年1月16日。
OBJECTIVE: Does platelet-rich plasma (PRP) intraovarian injection increase the number of retrieved oocytes in successive ovarian punctions among patients with poor ovarian reserve (POR)?
CONCLUSIONS: The injection of PRP increases the number of retrieved oocytes without increasing the quality of developed blastocysts.
BACKGROUND: Management of women with reduced ovarian response to stimulation is one of the significant challenges in reproductive medicine. Recently, PRP treatment has been proposed as an adjunct in assisted reproduction technology, with controversial results.
METHODS: This placebo-controlled, double-blind, randomized
trial included 60 patients with POR stratified according to the POSEIDON classification groups 3 and 4. It was conducted to explore the efficacy and safety of intraovarian PRP injection. Patients were proposed to undergo three consecutive ovarian stimulations to accumulate oocytes and were randomized to receive either PRP or placebo during their first oocyte retrieval. Randomization was performed using computer-generated randomization codes. Double blinding was ensured so that neither the participant nor the investigators knew of the treatment allotted. All patients underwent three ovarian stimulations and egg retrieval procedures. ICSI was performed after a third ovarian puncture. The primary endpoint was the number of mature oocytes retrieved after PRP or placebo injection in successive ovarian punctures.
METHODS: Sixty women (30-42 years) fulfilling inclusion criteria were randomized in equal proportions to the treatment or control groups.
RESULTS: The baseline demographic and clinical characteristics [age, BMI, anti-Müllerian hormone (AMH) levels] were comparable between the groups. Regarding the primary endpoint, the cumulative number (mean ± SEM) of retrieved mature oocytes was slightly higher in the treatment group: 10.45 ± 0.41 versus 8.91 ± 0.39 in the control group, respectively (95% CI of the difference 0.42-2.66; P = 0,008). The number of mature oocytes obtained among all patients increased in successive egg retrievals: 2.61 ± 0.33 (mean ± SEM) in punction 1 (P1), 3.85 ± 0.42 in P2, and 4.73 ± 0.44 in P3. However, the increase was higher among patients receiving the assessed PRP treatment. In P2, the number of retrieved mature oocytes was 4.18 ± 0.58 versus 3.27 ± 0.61 in controls (95% CI of the difference: -0.30 to 2.12; P = 0.138) and in P3, 5.27 ± 0.73 versus 4.15 ± 0.45 (95% CI of the difference: 0.12-2.12; P = 0.029). The mean ± SEM number of developed and biopsied blastocysts was 2.43 ± 0.60 in the control group and 1.90 ± 0.32 in the treatment group, respectively (P = 0.449). The mean number of euploid blastocysts was 0.81 ± 0.24 and 0.81 ± 0.25 in the control and treatment groups, respectively (P = 1.000). The percentages of patients with euploid blastocysts were 53.33% (16 out of 30) and 43.33% (13 out of 30) for patients in the control and treatment groups, respectively (Fisher\'s exact test P = 0.606). The overall pregnancy rate per ITT was 43% (26 out of 60 patients). However, the percentage of clinical pregnancies was higher in the control group (18 out of 30, 60%) than in the treatment group (8 out of 30, 27%) (P = 0.018). There was also a trend toward poorer outcomes in the treatment group when considering full-term pregnancies (P = 0.170). There were no differences between control and treatment groups regarding type of delivery, and sex of newborns.
CONCLUSIONS: The mechanism of the potential beneficial effect of PRP injection on the number of retrieved oocytes is unknown. Either delivered platelet factors or a mechanical effect could be implicated. Further studies will be needed to confirm or refute the data presented in this trial and to specify the exact mechanism of action, if any, of
PRP preparations.
CONCLUSIONS: The increasing number of women with a poor response to ovarian stimulation supports the exploration of new areas of research to know the potential benefits of therapies capable of increasing the number of oocytes available for fertilization and improving the quality of developed blastocysts. An increase in the retrieved oocytes in both arms of the trial suggests that, beyond the release of growth factor from platelets, a mechanical effect can play a role. However, neither improvement in euploid blastocyst development nor pregnancy rates have been demonstrated.
BACKGROUND: This
trial was supported by Basque Government and included in HAZITEK program, framed in the new Euskadi 2030 Science and Technology Plan (PCTI 2030). These aids are co-financed by the European Regional Development Fund (FEDER). The
study funders had no role in the
study design, implementation, analysis, manuscript preparation, or decision to submit this article for publication. No competing interests are declared by all the authors.
BACKGROUND: Clinical
Trial Number EudraCT 2020-000247-32.
UNASSIGNED: 3 November 2020.
UNASSIGNED: 16 January 2021.