A second dose of kisspeptin-54 improves oocyte maturation in women at high risk of ovarian hyperstimulation syndrome: a Phase 2 randomized controlled trial.

摘要: Study question Can increasing the duration of LH-exposure with a second dose kisspeptin-54 improve oocyte maturation in women at high risk ovarian hyperstimulation syndrome (OHSS)? Summary answer A 10 h following first improves yield OHSS. What is known already Kisspeptin acts hypothalamus to stimulate release an endogenous pool GnRH from hypothalamus. We have previously reported that single results LH-surge ~12-14 duration, which safely triggers design, size, Phase-2 randomized placebo-controlled trial 62 OHSS recruited between August 2015 and May 2016. Following controlled stimulation, all patients (n = 62) received subcutaneous injection (9.6 nmol/kg) 36 prior retrieval. Patients were 1:1 receive either (D; Double, n 31), or saline (S; Single, 31) thereafter. Patients, embryologists, IVF clinicians remained blinded dosing allocation. Participants/materials, setting, methods participants: Sixty-two aged 18-34 years (antral follicle count ≥23 anti-Mullerian hormone level ≥40 pmol/L). Setting: Single centre study carried out Hammersmith Hospital unit, London, UK. Primary outcome: Proportion achieving (percentage mature oocytes retrieved follicles ≥14 mm on morning trigger administration) least 60%. Secondary outcomes: Reproductive levels, implantation rate occurrence. Main role chance induced further LH-secretion 4 after administration. higher proportion achieved ≥60% (Single: 14/31, 45%, Double: 21/31, 71%; absolute difference +26%, CI 2-50%, P 0.042). receiving two doses had variable LH-response kisspeptin dose, appeared be dependent injection. who lower LH-rise more substantial 'rescue' kisspeptin. The resulted greater ≥60%, but without also frequency over-response moderate 1/31, 3.2%, 0/31, 0%). Limitations, reasons for caution Further studies are warranted directly compare established maturation. Wider implications findings Triggering final novel therapeutic option enable use fresh embryo transfer even woman funding/competing interest(s) was designed, conducted, analysed entirely by authors. Medical Research Council (MRC), Wellcome Trust & National Institute Health (NIHR) provided research funding carry studies. There no competing interests declare. Trial registration number Clinicaltrial.gov identifier NCT01667406. date 8 2012. Date patient's enrolment 2015.