首页> 外文OA文献 >The M-OVIN study: does switching treatment to FSH and / or IUI lead to higher pregnancy rates in a subset of women with world health organization type II anovulation not conceiving after six ovulatory cycles with clomiphene citrate - a randomised controlled trial
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The M-OVIN study: does switching treatment to FSH and / or IUI lead to higher pregnancy rates in a subset of women with world health organization type II anovulation not conceiving after six ovulatory cycles with clomiphene citrate - a randomised controlled trial

机译:M-OVIN研究:在接受了柠檬酸克罗米芬的六个排卵周期后,将治疗改为FSH和/或IUI是否会导致一部分具有世界卫生组织II型无排卵症的女性子集的怀孕率更高-一项随机对照试验

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摘要

Clomiphene citrate (CC) is first line treatment in women with World Health Organization (WHO) type II anovulation and polycystic ovary syndrome (PCOS). Whereas 60% to 85% of these women will ovulate on CC, only about one half will have conceived after six cycles. If women do not conceive, treatment can be continued with gonadotropins or intra-uterine insemination (IUI). At present, it is unclear for how many cycles ovulation induction with CC should be repeated, and when to switch to ovulation induction with gonadotropins and/or IUI. We started a multicenter randomised controlled trial in the Netherlands comparing six cycles of CC plus intercourse or six cycles of gonadotrophins plus intercourse or six cycles of CC plus IUI or six cycles of gonadotrophins plus IUI.Women with WHO type II anovulation who ovulate but did not conceive after six ovulatory cycles of CC with a maximum of 150 mg daily for five days will be included.Our primary outcome is birth of a healthy child resulting from a pregnancy that was established in the first eight months after randomisation. Secondary outcomes are clinical pregnancy, miscarriage, multiple pregnancy and treatment costs. The analysis will be performed according to the intention to treat principle. Two comparisons will be made, one in which CC is compared to gonadotrophins and one in which the addition of IUI is compared to ovulation induction only. Assuming a live birth rate of 40% after CC, 55% after addition of IUI and 55% after ovulation induction with gonadotrophins, with an alpha of 5% and a power of 80%, we need to recruit 200 women per arm (800 women in total).An independent Data and Safety Monitoring Committee has criticized the data of the first 150 women and concluded that a sample size re-estimation should be performed after including 320 patients (i.e. 80 per arm). The trial will provide evidence on the most effective, safest and most cost effective treatment in women with WHO type II anovulation who do not conceive after six ovulatory cycles with CC with a maximum of 150 mg daily for five days. This evidence could imply the need for changing our guidelines, which may cause a shift in large practice variation to evidence based primary treatment for these women. Netherlands Trial register NTR1449
机译:柠檬酸克罗米芬(CC)是世界卫生组织(WHO)II型无排卵和多囊卵巢综合征(PCOS)妇女的一线治疗。尽管这些女性中有60%至85%会通过CC排卵,但在六个周期后只有大约一半会受孕。如果妇女不怀孕,可以继续用促性腺激素或子宫内授精(IUI)进行治疗。目前,尚不清楚应将CC排卵诱导重复多少个周期,以及何时转换为促性腺激素和/或IUI的排卵诱导。我们在荷兰开始了一项多中心随机对照试验,比较了CC的六个周期加上性交或性腺的六个周期加上性交或CC的六个周期加上IUI的性交或六个周期的促性腺激素和IUI的六个周期。 CC的六个排卵周期后,每天最多150 mg,连续五天的怀孕将包括在内。我们的主要结局是,在随机分组后的前八个月内,因怀孕而出生了一个健康的孩子。次要结果是临床妊娠,流产,多次妊娠和治疗费用。将根据治疗原则进行分析。将进行两种比较,一种将CC与促性腺激素进行比较,另一种将IUI的添加仅与排卵诱导进行比较。假设CC后活产率为40%,加入IUI后活产率为55%,促性腺激素诱导排卵后为55%,α值为5%,功效为80%,我们每人需要招募200名女性(800名女性)一个独立的数据和安全监控委员会对前150名妇女的数据提出了批评,并得出结论,在包括320名患者(即每只手臂80名)之后,应重新进行样本量估计。该试验将提供证据,证明在六个排卵周期后,每天服用最多150 mg CC的六个排卵周期后未怀孕的WHO II型无排卵妇女,最有效,最安全和最具成本效益的治疗。这些证据可能意味着需要更改我们的指南,这可能导致大量的实践变化转向这些妇女基于证据的主要治疗。荷兰审判登记册NTR1449

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