与每日重组促卵泡素相比，用于接受卵胞浆内单精子注射患者的科丽福（重组促卵泡素β）：临床试验研究
Corifollitropin- compared to daily r-FSH in for patients undergoing intracytoplasmic sperm injection: Clinical trial study.
作者信息
Zahiri Sorouri Ziba, Pourmarzi Davoud, Safar Khah Niloufar
机构信息
Reproductive Health Research Center, Department of Obstetrics & Gynecology, Al-zahra Hospital, School of Medicine, Guilan University of Medical Sciences, Rasht, Iran.
Epidemiology, Reproductive Health Research Center, Gilan University of Medical Sciences, Rasht, Iran.
出版信息
Int J Reprod Biomed. 2019 Mar 3;17(1):23-32. doi: 10.18502/ijrm.v17i1.3817. eCollection 2019 Jan.
BACKGROUND
The current treatment regimen for ovarian stimulation in Intracytoplasmic sperm injection (ICSI) patients is daily injections of Gonadotropins. Recombinant DNA technologies have produced a new recombinant molecule that is a long-acting Follicle Stimulating Hormone (FSH), named corifollitropin alfa. A single injection of long-acting FSH can replace seven daily FSH injections during the first week of controlled ovarian stimulation (COS) and can make assisted reproduction more patients-friendly. There is limited data with different results in this area.
OBJECTIVE
To compare the effectiveness of long-acting FSH vs. daily r-FSH in terms of pregnancy and safety outcomes in women undergoing ICSI cycles.
MATERIALS AND METHODS
In this clinical trial study, 109 women who were the candidates for ICSI at azzahra hospital were divided in two groups. The first group received 150 units of daily Gonal-f from second or third day of menstruation. The second group received a 150IU corifollitropin alfa on the second or third day of mensuration, and the treatment continued from day eighth of stimulation with Gonal-f based on the ultrasound finding. Both the groups received GnRH antagonist from fifth day of stimulation. Two groups were compared in terms of number of dominant follicles, number of oocytes, stimulation duration, total number of embryos, number of transferred embryos, and success rate of pregnancy.
RESULTS
No significant difference was found between the two groups in terms of stimulation duration, number of follicles, number of oocytes, total number of embryos, and number of transferred embryos. Moreover, pregnancy outcomes including chemical pregnancy rate (positive pregnancy test), clinical pregnancy rate (detection of fetal heart), the rate of ovarian hyper-stimulation syndrome, multiple-pregnancy, ectopic pregnancy, and miscarriage didn't have a significant difference between the two groups.
CONCLUSION
As corifollitropin alfa was as effective as r-FSH, it could be used as an alternative to ovulation stimulation method in patients undergoing ICSI.
背景
目前，卵胞浆内单精子注射（ICSI）患者的卵巢刺激治疗方案是每日注射促性腺激素。重组DNA技术产生了一种新的重组分子，即长效促卵泡激素（FSH），名为注射用重组人促卵泡激素α。单次注射长效FSH可在控制性卵巢刺激（COS）的第一周替代七次每日FSH注射，并且可使辅助生殖对患者更友好。该领域的数据有限且结果各异。
目的
比较长效FSH与每日重组FSH在接受ICSI周期治疗的女性的妊娠及安全结局方面的有效性。
材料与方法
在这项临床试验研究中，109名在阿扎赫拉医院接受ICSI治疗的女性被分为两组。第一组从月经周期的第二天或第三天开始每日注射150单位果纳芬。第二组在月经周期的第二天或第三天注射150IU注射用重组人促卵泡激素α，并根据超声检查结果从刺激的第八天开始继续使用果纳芬治疗。两组均从刺激的第五天开始使用GnRH拮抗剂。比较两组的优势卵泡数量、卵母细胞数量、刺激持续时间、胚胎总数、移植胚胎数量及妊娠成功率。
结果
两组在刺激持续时间、卵泡数量、卵母细胞数量、胚胎总数及移植胚胎数量方面均未发现显著差异。此外，两组在妊娠结局方面，包括化学妊娠率（妊娠试验阳性）、临床妊娠率（检测到胎心）、卵巢过度刺激综合征发生率、多胎妊娠、异位妊娠及流产率方面均无显著差异。
结论
由于注射用重组人促卵泡激素α与重组FSH效果相同，它可作为接受ICSI治疗患者排卵刺激方法的替代方案。
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