Bordewijk E M, Mol F, van der Veen F, Van Wely M
Academic Medical Center, Center for Reproductive Medicine, Amsterdam, The Netherlands.
Hum Reprod Open. 2019 Jun 1;2019(3):hoz008. doi: 10.1093/hropen/hoz008. eCollection 2019.
In women undergoing IVF or ICSI cycles, do recombinant gonadotrophins differ from urinary-derived highly purified human menopausal gonadotropin (HP-hMG) or highly purified follicle-stimulating hormone (HP-FSH) in the total amount of gonadotrophins required to reach a live birth?
The difference between recombinant and urinary-derived HP-hMG or HP-FSH in the required amount to reach a live birth in IVF/ICSI cycles appears small.
At present, gynecologists can choose between recombinant FSH (rFSH), urinary-derived HP-hMG and HP-FSH. These products are equally effective and safe, but it is unknown how these gonadotrophins compare in terms of IU required to reach a live birth.
We conducted a search in Medline, Embase and CINAHL up to July 2018. We included randomized controlled trials (RCTs) that compared rFSH with HP-hMG or HP-FSH for ovarian stimulation in couples scheduled for IVF or ICSI treatment. From each randomized trial, we extracted the outcome data and information on participants, methods, interventions and funding.
PARTICIPANTS/MATERIALS SETTING AND METHODS: Women undergoing ovarian stimulation with rFSH, HP-hMG or HP-FSH were included. We extracted data for the mean amount of gonadotrophins with SD, clinical pregnancy rate, live birth rate and cumulative live birth rate per woman from the included RCTs. We summarized these outcomes by calculating the individual and pooled mean difference (MD) or relative risk (RR) with 95% CI. We used the Review Manager software to perform the meta-analyses. We applied a random effect model to pool the data. We estimated the total amount of gonadotrophins used per extra live birth by STATA 14.2 and R software.
A total of 28 studies with 7553 women were included in this review, of which 24 studies provided information on the total amount of gonadotrophins per woman who started an IVF/ICSI cycle. The total amount of gonadotrophins varied significantly between studies. The MDs in total amount were -37 IU (seven studies; = 3220; 95% CI, -115 to 41; = 68%) for rFSH versus HP-hMG and -31 IU (17 studies; = 3629; 95% CI, -290 to 228; = 97%) for rFSH versus HP-FSH. For rFSH versus HP-hMG, the RR for clinical pregnancy, live birth and cumulative live birth were 0.90 (95% CI, 0.81-1.00), 0.88 (95% CI, 0.78-0.99) and 0.91 (95% CI, 0.80-1.04), respectively. For rFSH versus HP-FSH, the RR for clinical pregnancy and live birth were 1.03 (95% CI, 0.94-1.13) and 1.03 (95% CI, 0.90-1.18), respectively; the data on cumulative live birth rate were lacking. The estimated difference in mean gonadotrophin amount per extra live birth was 789 IU (95% CI, -9.5 to 1570) for rFSH versus HP-hMG and -365 IU (95% CI, -2675 to 1945) for rFSH versus HP-FSH.
There was severe heterogeneity in the total amount of gonadotrophins between studies. A small fraction of women did not start gonadotrophin treatment; this was usually not accounted for in the provided mean amount of gonadotrophins per study and might have affected the averaged total amount of gonadotrophins but is unlikely to have affected the differences in the amount between rFSH and HP-hMG or HP-FSH.
The differences in the required amount to reach a live birth between rFSH, HP-hMG and HP-FSH appear to be small. Decision-making should be based on convenience, availability, actual costs and patient preferences.
STUDY FUNDING/COMPETING INTERESTS: The authors declare no conflict of interest. No external funding was either sought or obtained for this study.
Prospero CRD42016038238.
在接受体外受精（IVF）或卵胞浆内单精子注射（ICSI）周期治疗的女性中，重组促性腺激素与尿源性高纯度人绝经期促性腺激素（HP-hMG）或高纯度促卵泡生成素（HP-FSH）相比，在实现活产所需的促性腺激素总量上是否存在差异？
在IVF/ICSI周期中，重组促性腺激素与尿源性HP-hMG或HP-FSH在实现活产所需剂量方面的差异似乎很小。
目前，妇科医生可以在重组促卵泡生成素（rFSH）、尿源性HP-hMG和HP-FSH之间进行选择。这些产品同样有效且安全，但在实现活产所需的国际单位（IU）方面，这些促性腺激素之间的比较情况尚不清楚。
研究设计、规模与持续时间：我们检索了截至2018年7月的Medline、Embase和CINAHL数据库。我们纳入了将rFSH与HP-hMG或HP-FSH进行比较的随机对照试验（RCT），这些试验用于对计划接受IVF或ICSI治疗的夫妇进行卵巢刺激。从每个随机试验中，我们提取了结局数据以及关于参与者、方法、干预措施和资金来源的信息。
参与者/材料、设置与方法：纳入接受rFSH、HP-hMG或HP-FSH卵巢刺激的女性。我们从纳入的RCT中提取了每位女性促性腺激素的平均用量及标准差、临床妊娠率、活产率和累积活产率的数据。我们通过计算个体及合并的平均差（MD）或相对风险（RR）及95%置信区间（CI）来总结这些结局。我们使用Review Manager软件进行荟萃分析。我们应用随机效应模型来汇总数据。我们使用STATA 14.2和R软件估计每多一例活产所使用的促性腺激素总量。
本综述共纳入28项研究，涉及7553名女性，其中24项研究提供了开始IVF/ICSI周期的每位女性促性腺激素总量的信息。不同研究之间促性腺激素总量差异显著。rFSH与HP-hMG相比，总量的MD为-37 IU（7项研究；n = 3220；95% CI，-115至41；I² = 68%）；rFSH与HP-FSH相比，总量的MD为-31 IU（17项研究；n = 3629；95% CI，-290至228；I² = 97%）。rFSH与HP-hMG相比，临床妊娠、活产和累积活产的RR分别为0.90（95% CI，0.81 - 1.00）、0.88（95% CI，0.78 - 0.99）和0.91（95% CI，0.80 - 1.04）。rFSH与HP-FSH相比，临床妊娠和活产的RR分别为1.03（95% CI，0.94 - 1.13）和1.03（95% CI，0.90 - 1.18）；缺乏累积活产率的数据。rFSH与HP-hMG相比，每多一例活产促性腺激素平均用量的估计差异为789 IU（95% CI，-9.5至1570）；rFSH与HP-FSH相比，每多一例活产促性腺激素平均用量的估计差异为-365 IU（95% CI，-2675至1945）。
局限性、谨慎原因：不同研究之间促性腺激素总量存在严重异质性。一小部分女性未开始促性腺激素治疗；这在每项研究提供的促性腺激素平均用量中通常未被考虑，可能影响了促性腺激素的平均总量，但不太可能影响rFSH与HP-hMG或HP-FSH之间用量的差异。
rFSH、HP-hMG和HP-FSH在实现活产所需剂量方面的差异似乎很小。决策应基于便利性、可获得性、实际成本和患者偏好。
研究资金/利益冲突：作者声明无利益冲突。本研究未寻求或获得外部资金。
Prospero CRD42016038238
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