CN116577516A - 用于确定多囊卵巢综合征fsh起始剂量的标记物及其应用 - Google Patents
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Abstract
本发明公开了用于确定多囊卵巢综合征FSH起始剂量的标记物及其应用，所述标记物包括BMI、bFSH、bLH、AMH和AFC。本发明的标记物将有助于指导临床医生选择最合适的FSH起始剂量以获得最佳的取卵数，同时避免卵巢过度刺激综合征发生的风险。
Description
本申请要求2023年4月20日提交的中国专利申请2023104280405的优先权，该专利申请据此全文以引用方式并入本文。
技术领域
本发明属于生物医药技术领域，具体涉及一种用于确定多囊卵巢综合征FSH起始剂量的标记物及其应用。
背景技术
多囊卵巢综合征(PCOS)是妇女中最常见的生殖内分泌和代谢紊乱性疾病，大约15-20％的不孕妇女患有多囊卵巢综合症，是80％的患者无排卵不孕的主要原因。
PCOS患者若在接受枸橼酸氯米芬/来曲唑促排卵后仍未怀孕，或合并有输卵管和/或男性因素不孕情况下，体外受精(IVF)/卵胞浆内单精子注射(ICSI)-胚胎移植(ET)是一种有效的解决PCOS不孕患者生育要求的治疗方法。其中，促性腺激素释放激素拮抗剂(GnRH-ant)方案是PCOS妇女的首选，因为它的卵巢刺激时间短，治疗剂量减少，卵巢过度刺激综合征(OHSS)发生率低。但是，较低剂量的卵泡刺激素(FSH)起始剂量会导致卵泡生长不良，获卵数少，周期取消率升高，而较高的FSH起始剂量大大增加了卵巢过度刺激的风险，同时高水平的雌激素也可能影响子宫内膜的容受性，进而影响临床妊娠率。因此，适当的FSH起始剂量被认为可以明显改善PCOS患者的IVF/ICSI临床结果。
根据现有的国内外证据，认为15个获卵数是最佳卵母细胞产量。既往临床医生通常根据年龄、体重、体重指数、既往IVF周期的卵巢反应以及包括FSH、AMH和AFC在内的卵巢储备指标来确定FSH起始剂量。既往有少数研究者提出根据患者年龄、基础FSH水平、AFC或AMH水平计算IVF周期中超长方案最合适的FSH起始剂量，以帮助不孕患者获得最佳反应。迄今为止，未有人在PCOS人群上研究拮抗剂方案的最佳FSH起始剂量，因此本研究有重要的临床意义和实践价值。
发明内容
为了弥补现有技术的不足，本发明的目的在于一种用于确定多囊卵巢综合征FSH起始剂量的标记物及其应用。为了实现本发明的目的，拟采用如下技术方案：
本发明提供了一种用于确定多囊卵巢综合征FSH起始剂量的标记物，其包括身体质量指数(BMI)、基础卵泡刺激素(bFSH)、基础黄体生成素(bLH)、抗苗勒管激素(AMH)和窦卵泡数(AFC)。
在本发明的一个优选实施方式中，所述多囊卵巢综合征的患者年龄为20-40岁。
在本发明的一个优选实施方式中，所述FSH起始剂量是体外受精(IVF)/卵胞浆内单精子注射(ICSI)-胚胎移植(ET)治疗中的FSH起始剂量。
本发明另一方面涉及一种确定多囊卵巢综合征FSH起始剂量的方法，所述方法包括检测患者的BMI、bFSH、bLH、AMH和AFC。
在本发明的一个优选实施方式中，所述FSH起始剂量为FSH＝(0.491×BMI+1.312×bFSH-0.291×bLH-0.455×AMH-0.075×AFC-8.576)/0.042，其中FSH的单位是IU/天，BMI的单位是kg/m2，bFSH的单位是IU/L，bLH的单位是IU/L，AMH的单位是ng/ml，AFC的单位是个。
本发明另一方面涉及一种用于确定多囊卵巢综合征FSH起始剂量的试剂盒，所述试剂盒包括定量检测BMI、bFSH、bLH、AMH和AFC的试剂。
本发明另一方面还涉及上述标记物或试剂盒在制备确定多囊卵巢综合征FSH起始剂量的诊断试剂中的应用。
本发明的有益效果在于确定最合适的FSH起始剂量以获得最佳的取卵数(15个)保证一个良好的临床结局，同时避免发生卵巢过度刺激综合征。
附图说明
图1是用于计算FSH起始剂量的Nomogram图。在这个例子中，对于体重指数BMI＝28kg/m2，bFSH＝6IU/L，bLH＝8IU/L，AMH＝8ng/ml，AFC＝24个的PCOS患者，预测的FSH起始剂量为125IU/天。
图2是通过本研究的Nomogram图计算的预测的FSH起始剂量与实际FSH起始剂量之间的差异以测试这个Nomogram图的有效性。在获卵数为15个的PCOS患者中，我们预测的FSH起始用量与实际用量几乎相同；当获卵数少于15个时，实际用量明显低于预测用量；同样地，当获卵数超过15个时，实际用量明显高于预测用量。
具体实施方式
为了进一步理解本发明，下面将结合本发明实施例，对本发明实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。
如无特殊说明，本发明实施例中所涉及的试剂均为市售产品，均可以通过商业渠道购买获得。
实施例1：
本研究根据北医三院生殖中心1898例接受GnRH-ant方案的首次IVF/ICSI周期的PCOS妇女(20-40岁)临床相关指标，筛选了一套适用于计算最佳FSH起始剂量的预测指标集。
本研究严格根据纳排标准纳入了2017年至2021年1898例PCOS患者。
纳入标准：(1)20至40岁的育龄妇女；(2)根据2003年修订的鹿特丹诊断标准诊断为多囊卵巢综合症的妇女，至少满足3个标准中的2个—无排卵和/或无排卵，高雄激素的临床和/或生化指标，以及多囊卵巢(每侧卵巢数≥12个卵泡)，并排除其他病因(先天性肾上腺增生症、分泌雄性激素的肿瘤、库欣综合征等)；(3)第1次接受IVF/ICSI周期的妇女；(4)接受GnRH-ant方案促排卵的妇女；以及(5)具有完整的临床和IVF周期的患者信息。
排除标准：(1)夫妻一方染色体异常；(2)既往有卵巢疾病或手术史，如卵巢子宫内膜异位囊肿、卵巢肿瘤、卵巢打孔术或卵巢囊肿或肿瘤切除术史；(3)体外成熟周期。
GnRH-ant方案
从月经周期的第2-3天开始，每天注射促性腺激素(Gn，本研究中为FSH)。Gn注射第5天起做经阴道超声检查，监测卵泡发育情况，以便根据卵巢的反应调整药物剂量。GnRH-ant的给药时间有两种选择：(1)固定给药方案，在Gn给药后的第5-7天加入拮抗剂；(2)灵活给药方案，在优势卵泡直径达到12毫米时加入拮抗剂，直到HCG日。当至少有3个卵泡直径>17毫米时，注射尿促性腺激素(hCG)，剂量为5000-10000IU或250ug重组hCG。有OHSS高风险的患者以0.2mg GnRH-a或与低剂量的hCG结合作为扳机，以减少OHSS发生风险。36-38小时后进行取卵。
本研究将可能与获卵数相关的以下因素进行单因素分析，包括年龄、不孕类型、不孕年限、生产与否、BMI、基础FSH(bFSH)水平、基础LH(bLH)水平、AMH水平、AFC，发现年龄、生产与否、BMI、bFSH、bLH、AMH、AFC与获卵数显著相关，结果如表1所示。
表1：获卵数相关的因素的单因素和多因素分析结果
研究进一步将单因素分析有显著差异的指标进行多因素分析，发现只有BMI和卵巢储备标志物(包括bFSH、bLH、AMH和AFC)与获卵数显著相关。据此，本研究成功筛选出适用于计算最佳FSH起始剂量的预测指标(BMI、bFSH、bLH、AMH、AFC)，并进一步提出了，对于接受GnRH-ant方案的IVF/ICSI的PCOS患者的最佳FSH起始剂量的预测模型FSH＝(0.491×BMI+1.312×bFSH-0.291×bLH-0.455×AMH-0.075×AFC-8.576)/0.042。该模型将有助于指导临床医生在未来本部分人群中选择最合适的FSH起始剂量，结果如表2和图1所示。
表2计算FSH起始剂量的Nomogram.
如图1所示，对于20-40岁的PCOS患者，其BMI＝28kg/m2，基础FSH水平＝6IU/L，基础LH水平＝8IU/L，AMH水平＝8ng/ml，AFC＝24，则预测的最佳FSH起始剂量为125IU/天。
为测试本研究预测模型的效用，我们将这个模型应用于PCOS人群队列。PCOS女性促排卵的最低初始FSH剂量根据临床经验设定为112.5IU/天，以防止卵泡不生长及促排周期取消。在获卵数等于15个的PCOS患者中，我们应用此模型预测的FSH起始用量与实际用量几乎相同。当获卵数少于15个时，临床实际用量明显低于预测用量。同样地，当获卵数超过15个时，实际用量明显高于预测用量，实验结果如图2所示。这些结果进一步验证了本研究预测模型的可靠性。
以上描述了本发明优选实施方式，然其并非用以限定本发明。本领域技术人员对在此公开的实施方案可进行并不偏离本发明范畴和精神的改进和变化。
Claims (8)
1.一种用于确定多囊卵巢综合征FSH起始剂量的标记物，其包括BMI、bFSH、bLH、AMH和AFC。
2.根据权利要求1所述的标记物，所述多囊卵巢综合征的患者年龄为20-40岁。
3.根据权利要求1所述的标记物，所述FSH起始剂量是体外受精(IVF)/卵胞浆内单精子注射(ICSI)-胚胎移植(ET)治疗中的FSH起始剂量。
4.一种确定多囊卵巢综合征FSH起始剂量的方法，所述方法包括检测患者的BMI、bFSH、bLH、AMH和AFC。
5.根据权利要求4所述的方法，所述FSH起始剂量为FSH＝(0.491×BMI+1.312×bFSH-0.291×bLH-0.455×AMH-0.075×AFC-8.576)/0.042，其中FSH的单位是IU/天，BMI的单位是kg/m2，bFSH的单位是IU/L，bLH的单位是IU/L，AMH的单位是ng/ml，AFC的单位是个。
6.一种用于确定多囊卵巢综合征FSH起始剂量的试剂盒，所述试剂盒包括定量检测BMI、bFSH、bLH、AMH和AFC的试剂。
7.权利要求1-3任意一项所述标记物在制备确定多囊卵巢综合征FSH起始剂量的诊断试剂中的应用。
8.权利要求6所述试剂盒在制备确定多囊卵巢综合征FSH起始剂量的诊断试剂中的应用。
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