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我的设计我做主:MedSci临床研究方案设计活动(第二轮)-立题公布(2)

2015-07-09 MedSci MedSci原创

任务目标:完成一份辅助生殖相关的临床研究设计 在发布的立题选项中,看下方 任务一(2015.7.6发布):临床研究立题(方向) 请各位从以下研究立题中选择一个,开展后续的研究设计任务: A. 卵巢低反应对于IVF妊娠结局的影响 B. OHSS发生的相关风险因素 C. XX激素水平(或者其他biomarker指标)是否可以预测IVF妊娠结局 D. 两种促排方

任务目标:完成一份辅助生殖相关的临床研究设计

在发布的立题选项中,看下方

任务一(2015.7.6发布):临床研究立题(方向)

请各位从以下研究立题中选择一个,开展后续的研究设计任务:

A. 卵巢低反应对于IVF妊娠结局的影响

B. OHSS发生的相关风险因素

C. XX激素水平(或者其他biomarker指标)是否可以预测IVF妊娠结局

D. 两种促排方案(或IVF过程中的其他方案/辅助方案)之间的比较

E. 对于肥胖或体重超标者实施体重控制或干预(减轻体重)对于IV     妊娠结局的影响

F. 二甲双胍是否有助于改善PCOS患者的IVF结局(或者对于二甲双胍相关治疗方案优化的研究)


经过昨日的投票,微信群统计出的投票结果有变化哦:



我们非常认同各位的选择,确实这些研究方向是目前辅助生殖相关研究的热点,那么今天我在这里与大家分享一下关于E选项,即“对于肥胖或体重超标者实施体重控制或干预(减轻体重)对于IVF妊娠结局的影响”。仅供参考。


对于肥胖或体重超标者实施体重控制或干预(减轻体重)对于IVF妊娠结局的影响

相关的研究成果不少(fig 1 Pubmed上粗略的检索结果),正在进行或已经结束的注册研究也有一些(fig 2 www.clinicaltrials.gov上注册的研究,fig 3 注册研究分布的国家、地区)。

此类研究在中国乃至亚洲地区均未有注册研究,因此如果本课题成立,并进行注册,也可能是国内最早注册的相关研究方案之一。

此类研究设计有一定的“规律”可循,如果最后选择这个方向,我们会在“任务二·研究类型的选择”中与大家进行探讨。

分析这个立题,我们不难发现有几个关键词,即“肥胖或体重超标”、“体重控制或干预”、“结局”。那么对于研究立题的完善或者细化,我们就应该从这三个方面进行:

1.肥胖或体重超标:需要根据“指南”、“共识”或同行标准进行定义,建议大家借此机会进行复习。

这个“定义”还有一个关键点,即何时定义为肥胖或体重超标,应该对纳入研究的对象进行体重或BMI测量,并且应该规定同一时间的测量结果进行记录。这一点一定要在方案中注明。

2.体重控制或干预:这里需要包括干预方案,如饮食、运动、药物等;还要考虑是否干预?是否都实施干预?如果不进行干预或无法干预,进行观察性研究是否可行?如果干预,如何评价干预效果?

3.结局:体重结局是一定要在本研究中进行评估的,而且也要注意测量的时间点保持一致的问题。其他的IVF结局大家可以进行选择,这个并不困难。

针对上述问题,我们可以结合一个案例,进一步的理解:

Physical activity before IVF and ICSI cycles in infertile obese women: an observational cohort study. Reprod Biomed Online. 2014 Jul;29(1):72-9.

这是一个非常简单的研究设计,而且不需要很大的样本量,很适合临床医生进行操作,值得大家借鉴。当然,这也不是一个“完美”的设计,如没有进行随机分组,干预措施制定和实施监测等细节,受限于“观察性研究”,控制得并不严格。不过这个研究的结果还是值得我们借鉴的。


Figure 1 Pubmed上粗略的检索结果(检索“(obsesity OR overweight) and IVF”,限定clinical trail)


Figure 2  www.clinicaltrials.gov上注册的研究
https://www.clinicaltrials.gov/ct2/results?term=obesity+and+IVF&Search=Search


Figure 3注册研究分布的国家、地区

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    2015-07-12 huaxipanxing

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    2015-07-10 owlhealth

    看看

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=1688747, encodeId=63be1688e47d7, content=<a href='/topic/show?id=c011e3406a8' target=_blank style='color:#2F92EE;'>#研究方案#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=77, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=73406, encryptionId=c011e3406a8, topicName=研究方案)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=13f028628303, createdName=ms8543593053280928, createdTime=Sun Nov 15 15:33:00 CST 2015, time=2015-11-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2016224, encodeId=b90c201622415, content=<a href='/topic/show?id=5fc458e751c' target=_blank style='color:#2F92EE;'>#方案设计#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58775, encryptionId=5fc458e751c, topicName=方案设计)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=395f25, createdName=爆笑小医, createdTime=Sun Dec 20 23:33:00 CST 2015, time=2015-12-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=32474, encodeId=8242324e470, content=看看, beContent=null, objectType=article, channel=null, level=null, likeNumber=154, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ee0d1618732, createdName=huaxipanxing, createdTime=Sun Jul 12 16:44:00 CST 2015, time=2015-07-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1606538, encodeId=88cb1606538e5, content=<a href='/topic/show?id=eb6b1145939' target=_blank style='color:#2F92EE;'>#Med#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=89, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11459, encryptionId=eb6b1145939, topicName=Med)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=552a19396740, createdName=ms3994565386320060, createdTime=Sat Jul 11 07:33:00 CST 2015, time=2015-07-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=32230, encodeId=9e103223059, content=看看, beContent=null, objectType=article, channel=null, level=null, likeNumber=181, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3b2c1627329, createdName=owlhealth, createdTime=Fri Jul 10 13:44:00 CST 2015, time=2015-07-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=32185, encodeId=12e3321859f, content=挺好, beContent=null, objectType=article, channel=null, level=null, likeNumber=158, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=db141627504, createdName=chenguoyan, createdTime=Fri Jul 10 05:21:00 CST 2015, time=2015-07-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=32071, encodeId=5935320e1e6, content=有意思, beContent=null, objectType=article, channel=null, level=null, likeNumber=186, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=96871613250, createdName=medcardio, createdTime=Thu Jul 09 19:53:00 CST 2015, time=2015-07-09, status=1, ipAttribution=)]
    2015-07-10 chenguoyan

    挺好

    0

  7. [GetPortalCommentsPageByObjectIdResponse(id=1688747, encodeId=63be1688e47d7, content=<a href='/topic/show?id=c011e3406a8' target=_blank style='color:#2F92EE;'>#研究方案#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=77, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=73406, encryptionId=c011e3406a8, topicName=研究方案)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=13f028628303, createdName=ms8543593053280928, createdTime=Sun Nov 15 15:33:00 CST 2015, time=2015-11-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2016224, encodeId=b90c201622415, content=<a href='/topic/show?id=5fc458e751c' target=_blank style='color:#2F92EE;'>#方案设计#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58775, encryptionId=5fc458e751c, topicName=方案设计)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=395f25, createdName=爆笑小医, createdTime=Sun Dec 20 23:33:00 CST 2015, time=2015-12-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=32474, encodeId=8242324e470, content=看看, beContent=null, objectType=article, channel=null, level=null, likeNumber=154, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ee0d1618732, createdName=huaxipanxing, createdTime=Sun Jul 12 16:44:00 CST 2015, time=2015-07-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1606538, encodeId=88cb1606538e5, content=<a href='/topic/show?id=eb6b1145939' target=_blank style='color:#2F92EE;'>#Med#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=89, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11459, encryptionId=eb6b1145939, topicName=Med)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=552a19396740, createdName=ms3994565386320060, createdTime=Sat Jul 11 07:33:00 CST 2015, time=2015-07-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=32230, encodeId=9e103223059, content=看看, beContent=null, objectType=article, channel=null, level=null, likeNumber=181, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3b2c1627329, createdName=owlhealth, createdTime=Fri Jul 10 13:44:00 CST 2015, time=2015-07-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=32185, encodeId=12e3321859f, content=挺好, beContent=null, objectType=article, channel=null, level=null, likeNumber=158, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=db141627504, createdName=chenguoyan, createdTime=Fri Jul 10 05:21:00 CST 2015, time=2015-07-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=32071, encodeId=5935320e1e6, content=有意思, beContent=null, objectType=article, channel=null, level=null, likeNumber=186, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=96871613250, createdName=medcardio, createdTime=Thu Jul 09 19:53:00 CST 2015, time=2015-07-09, status=1, ipAttribution=)]
    2015-07-09 medcardio

    有意思

    0

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