Efficacy of Kisspeptin-54 to Trigger Oocyte Maturation in Women at High Risk of Ovarian Hyperstimulation Syndrome (OHSS) During In Vitro Fertilization (IVF) Therapy.
Efficacy of Kisspeptin-54 to Trigger Oocyte Maturation in Women at High Risk of Ovarian Hyperstimulation Syndrome (OHSS) During In Vitro Fertilization (IVF) Therapy.
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DOI：
10.1210/jc.2015-2332
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发表时间：
2015-09
期刊：
影响因子：
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通讯作者：
Dhillo WS
中科院分区：
文献类型：
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作者：
Abbara A;Jayasena CN;Christopoulos G;Narayanaswamy S;Izzi-Engbeaya C;Nijher GM;Comninos AN;Peters D;Buckley A;Ratnasabapathy R;Prague JK;Salim R;Lavery SA;Bloom SR;Szigeti M;Ashby DA;Trew GH;Dhillo WS
体外受精（IVF）治疗是不孕症的有效治疗方法，但可能导致潜在的危及生命的并发症，卵巢过度刺激综合征（OHSS）。本研究旨在研究kisspeptin-54是否可以用于有效和安全地触发接受IVF治疗的OHSS高危女性的卵母细胞成熟。这是一项在英国伦敦Hammersmith医院IVF中心于2013-2014年期间对60名OHSS高风险女性进行的II期、多剂量、开放标签、随机临床试验。按照标准重组FSH/GnRH拮抗剂方案，患者被随机分配接受Kisspeptin-54单次注射，以使用剂量分配的适应性设计（3.2 nmol/kg，n = 5; 6.4 nmol/kg，n = 20; 9.6 nmol/kg，n = 15; 12.8 nmol/kg，n = 20）触发卵母细胞成熟。在kisspeptin-54给药后36 h取出卵母细胞，评估其成熟情况，并通过胞浆内单精子注射受精，随后移植1个或2个胚胎。对妇女进行常规筛查，以了解OHSS的发展情况。通过卵母细胞产率（超声检查从≥ 14 mm卵泡中取出的成熟卵母细胞百分比）测量卵母细胞成熟度。次要结局包括OHSS和妊娠率。95%的女性发生卵母细胞成熟。在12.8 nmol/kg kisspeptin-54后观察到最高的卵母细胞产量（121%），比3.2 nmol/kg高+69%（置信区间，-16-153%）。在所有剂量的kisspeptin-54，生化妊娠，临床妊娠和活产率每次转移（n = 51）分别为63，53和45%。在9.6 nmol/kg kisspeptin-54后观察到最高妊娠率（分别为85、77和62%）。没有女性发生中度、重度或临界OHSS。Kisspeptin-54是一种有前途的方法，可以有效和安全地触发接受IVF治疗的OHSS高风险女性的卵母细胞成熟。
In vitro fertilization (IVF) treatment is an effective therapy for infertility, but can result in the potentially life-threatening complication, ovarian hyperstimulation syndrome (OHSS). This study aimed to investigate whether kisspeptin-54 can be used to effectively and safely trigger oocyte maturation in women undergoing IVF treatment at high risk of developing OHSS. This was a phase 2, multi-dose, open-label, randomized clinical trial of 60 women at high risk of developing OHSS carried out during 2013–2014 at Hammersmith Hospital IVF unit, London, United Kingdom. Following a standard recombinant FSH/GnRH antagonist protocol, patients were randomly assigned to receive a single injection of kisspeptin-54 to trigger oocyte maturation using an adaptive design for dose allocation (3.2 nmol/kg, n = 5; 6.4 nmol/kg, n = 20; 9.6 nmol/kg, n = 15; 12.8 nmol/kg, n = 20). Oocytes were retrieved 36 h after kisspeptin-54 administration, assessed for maturation, and fertilized by intracytoplasmic sperm injection with subsequent transfer of one or two embryos. Women were routinely screened for the development of OHSS. Oocyte maturation was measured by oocyte yield (percentage of mature oocytes retrieved from follicles ≥ 14 mm on ultrasound). Secondary outcomes include rates of OHSS and pregnancy. Oocyte maturation occurred in 95% of women. Highest oocyte yield (121%) was observed following 12.8 nmol/kg kisspeptin-54, which was +69% (confidence interval, −16–153%) greater than following 3.2 nmol/kg. At all doses of kisspeptin-54, biochemical pregnancy, clinical pregnancy, and live birth rates per transfer (n = 51) were 63, 53, and 45%, respectively. Highest pregnancy rates were observed following 9.6 nmol/kg kisspeptin-54 (85, 77, and 62%, respectively). No woman developed moderate, severe, or critical OHSS. Kisspeptin-54 is a promising approach to effectively and safely trigger oocyte maturation in women undergoing IVF treatment at high risk of developing OHSS.