期刊
JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM
卷 100, 期 9, 页码 3322-3331出版社
ENDOCRINE SOC
DOI: 10.1210/jc.2015-2332
关键词
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资金
- Medical Research Council (MRC)
- Wellcome Trust
- National Institutes of Health Research
- Biotechnology and Biological Sciences Research Council
- National Institutes of Health Research (NIHR)
- NIHR
- Wellcome Translational Medicine Research Fellowship
- MRC Clinical Training Fellowship
- NIHR Academic Clinical Fellowship
- Medical Research Council [MR/M004171/1] Funding Source: researchfish
- National Institute for Health Research [ACF-2012-21-003, CL-2015-21-003, ACF-2011-21-004, NF-SI-0513-10080, RP-2014-05-001, ACF-2008-21-018, NF-SI-0507-10337, ACF-2010-21-015, CL-2014-21-003, CDF-2009-02-05, CL-2009-21-004] Funding Source: researchfish
- MRC [MR/M004171/1] Funding Source: UKRI
Context: In vitro fertilization (IVF) treatment is an effective therapy for infertility, but can result in the potentially life-threatening complication, ovarian hyperstimulation syndrome (OHSS). Objective: 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. Setting and Design: 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. Intervention: Following a standard recombinant FSH/GnRH antagonist protocol, patients were randomly assigned to receive a single injection of kisspepti n-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 kisspepti n-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. Main Outcome Measure: 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. Results: 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 kisspepti n-54 (85, 77, and 62%, respectively). No woman developed moderate, severe, or critical OHSS. Conclusion: Kisspeptin-54 is a promising approach to effectively and safely trigger oocyte maturation in women undergoing IVF treatment at high risk of developing OHSS.
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