Vuong N L, Pham D T, Phung H T, Giang H N, Huynh G B, Nguyen T T L, Ho M T
Department of Obstetrics and Gynaecology, University of Medicine and Pharmacy at Ho Chi Minh City, 217 Hong Bang Street, District 5, Ho Chi Minh City, Vietnam.
IVFMD, My Duc Hospital, 4 Nui Thanh Street, District Tan Binh, Ho Chi Minh City, Vietnam.
Hum Reprod Open. 2017 Nov 28;2017(3):hox023. doi: 10.1093/hropen/hox023. eCollection 2017.
Is corifollitropin alfa 150 μg equivalent to follitropin beta 300 IU/day for controlled ovarian hyperstimulation (COS) in older women weighing ≥50 kg undergoing IVF and/or ICSI in Vietnam?
Corifollitropin alfa 150 μg was equivalent to follitropin beta 300 IU/day with respect to the number of oocytes retrieved, the ongoing, cumulative and live birth rates and obstetric outcomes.
Corifollitropin alfa is a recombinant FSH (rFSH) preparation with slow absorption and a long half-life allowing administration of a single dose for COS lasting 7 days. Several randomized, controlled clinical trials have reported that COS with corifollitropin alfa is associated with similar outcomes compared with COS using daily rFSH. However, limited data are available in Asian patients.
This randomized controlled trial was conducted at a single large IVF centre in Vietnam from June 2015 to August 2016. A total of 400 patients were included, 200 in each treatment group. The primary outcome measure was the number of oocytes retrieved. Patients were followed for 1 year after randomization.
PARTICIPANTS /MATERIALS SETTING METHODS: Participants aged 35-42 years with a body weight ≥50 kg who were undergoing an IVF cycle were randomized to undergo COS with a single dose of corifollitropin alfa 150 μg on Day 2 or 3 of the menstrual cycle, or follitropin beta 300 IU/day for 7 days starting on Day 2 or 3 of the menstrual cycle. All underwent ICSI according to standard institutional protocols. A beta hCG test was performed 17 days after ovum pick-up, and positive tests were confirmed on vaginal and/or abdominal ultrasound at 5-6 weeks after embryo transfer (clinical pregnancy) and at ≥10 weeks (ongoing pregnancy). Rates of ovarian hyperstimulation syndrome, and maternal and foetal outcomes after one cycle of ICSI were monitored over 12 months.
Patients in the corifollitropin alfa and follitropin beta groups were well matched at baseline (mean age 37.5 ± 1.9 vs 37.7 ± 2.0 years, mean body weight 53.7 ± 5.4 vs 52.5 ± 4.8 kg). There was no significant difference between the corifollitropin alfa and follitropin beta groups in the number of oocytes retrieved (11.4 ± 5.9 vs 10.8 ± 5.8; = 0.338). The ongoing pregnancy rate (31.5 vs 32.0%; = 0.99) and live birth rate (30.5 vs 32.0%; = 0.83) (both per initiated cycle at 12 months after randomization) were also similar in the two treatment groups. Complication rates were low and similar in the corifollitropin alfa and follitropin beta groups, and there were no significant between-group differences in obstetric outcomes.
This study had an open-label design, and therefore, the potential for bias cannot be excluded. The findings are only applicable to patient populations with similar characteristics to those enroled in the study.
This study adds to the body of evidence supporting the equivalence of corifollitropin alfa and follitropin beta for COS in a variety of patients undergoing IVF and/or ICSI. The ability to provide COS with corifollitropin alfa has the potential to reduce the burden of treatment for patients.
STUDY FUNDING/COMPETING INTERESTS: This study was supported by Merck Sharp and Dohme. The authors state that they have no financial or commercial conflicts of interest.
The trial was registered with clinicaltrials.gov (NCT02466204).
2 June 2015.
DATE OF FIRST PATIENT’S ENROLMENT: 19 June 2015.
对于越南体重≥50kg且接受体外受精（IVF）和/或卵胞浆内单精子注射（ICSI）的老年女性，150μg的注射用重组促卵泡素α与300IU/天的重组促卵泡素β在控制性卵巢刺激（COS）中是否等效？
就获卵数、持续妊娠率、累积妊娠率、活产率及产科结局而言，150μg的注射用重组促卵泡素α与300IU/天的重组促卵泡素β等效。
注射用重组促卵泡素α是一种重组促卵泡激素（rFSH）制剂，吸收缓慢，半衰期长，可单次给药用于持续7天的COS。多项随机对照临床试验报告称，与每日使用rFSH进行COS相比，使用注射用重组促卵泡素α进行COS的结局相似。然而，亚洲患者的数据有限。
本随机对照试验于2015年6月至2016年8月在越南一家大型IVF中心进行。共纳入400例患者，每个治疗组200例。主要结局指标为获卵数。随机分组后对患者随访1年。
参与者/材料设置方法：年龄35 - 42岁、体重≥50kg且正在接受IVF周期的参与者被随机分为两组，一组在月经周期第2或3天接受单剂量150μg的注射用重组促卵泡素α进行COS，另一组从月经周期第2或3天开始每天接受300IU的重组促卵泡素β共7天进行COS。所有患者均根据标准机构方案接受ICSI。取卵后17天进行β - hCG检测，在胚胎移植后5 - 6周（临床妊娠）及≥10周（持续妊娠）时通过阴道和/或腹部超声确认阳性检测结果。在12个月内监测ICSI一个周期后的卵巢过度刺激综合征发生率以及母婴结局。
注射用重组促卵泡素α组和重组促卵泡素β组患者在基线时匹配良好（平均年龄37.5±1.9岁对37.7±2.0岁，平均体重53.7±5.4kg对52.5±4.8kg）。注射用重组促卵泡素α组和重组促卵泡素β组之间的获卵数无显著差异（11.4±5.9对10.8±5.8；P = 0.338）。两个治疗组的持续妊娠率（31.5%对32.0%；P = 0.99）和活产率（30.5%对32.0%；P = 0.83）（均为随机分组后12个月时每个启动周期的情况）也相似。注射用重组促卵泡素α组和重组促卵泡素β组的并发症发生率较低且相似，产科结局在组间无显著差异。
本研究采用开放标签设计，因此不能排除偏倚的可能性。研究结果仅适用于与研究纳入患者特征相似的人群。
本研究增加了支持注射用重组促卵泡素α和重组促卵泡素β在各种接受IVF和/或ICSI患者中进行COS等效性的证据。使用注射用重组促卵泡素α进行COS的能力有可能减轻患者的治疗负担。
研究资金/利益冲突：本研究由默克雪兰诺公司资助。作者声明他们没有财务或商业利益冲突。
该试验在clinicaltrials.gov注册（NCT02466204）。
2015年6月2日。
2015年6月19日。
