目的:在36.6°C或37.1°C稳定培养的情况下,在第5天单胚胎移植(SET)后的良好预后患者的临床妊娠率(CPRs)是否存在差异?
结论:在36.6°C或37.1°C培养后,囊胚移植后的CPR(在7周时有心跳)没有差异。
背景:自从IVF开始以来,胚胎培养已在37.0°C进行;然而,最佳培养温度仍然未知。培养箱类型的变化导致温度控制的显著改善。稳定的温度控制,即与最大的温差。室间0.1°C,在一些孵化器中是可能的。先前的前瞻性试点研究表明,当胚胎在36.6°C或37.1°C的稳定温度下培养时,第5/6天的胚胎发育不会受到影响,但与36.6°C培养相比,37.1°C培养导致CPR增加(74.2%vs46.4%)。
方法:一项前瞻性随机对照试验于2017年2月至2022年11月26日在三级生育中心进行。使用具有连续性校正的双侧z检验,需要89/89例具有新鲜单胚胎移植(SET)的患者的样本量达到80%的能力以在0.05的显著性水平下检测到组比例之间的0.22的差异(0.43-0.65)。
方法:根据纳入标准,在取卵当天招募患者,一旦出现6个成熟卵母细胞,则在剥脱后进行最终随机分组。主要终点是CPR(7周时的心跳);次要终点是受精率,囊胚发育,生化妊娠率,活产率(LBR),和累计活产率(CLBR)。
结果:共有304名患者符合研究条件;其中268名患者签署了同意书,将234(意向治疗)随机化,并在第5天将181(按照方案)接受SET:在36.6°C下接受90培养,在37.1°C下接受91培养。患者平均年龄为32.4±3.5岁和32.5±4.2岁,分别。在36.6°C和37.1°C的培养之间,每个周期的胚胎结局没有观察到差异:12.0±3.8vs12.1±3.8COC(P=0.88),10.0±3.1和9.9±2.9成熟卵母细胞授精(P=0.68),成熟率为84.2%(901/1083)对83.5%(898/1104)(P=0.87);8.0±3.1对7.9±2.7正常受精卵母细胞的受精率为79.7%(720/901)对80.5%(718/898)(P=0.96),分别。分别在第5天和第6天玻璃化平均1.5±1.7对1.4±1.9(P=0.25)和1.1±1.1对0.9±1.0(P=0.45)的多余胚泡。每个受精卵母细胞的利用率为41.5%,分别为46.1%和41.5%(P=0.14)。对181名患者进行了SET检查,生化妊娠率为72.2%(65/90)与62.7%(57/91)(P=0.17),分别。每个新鲜转移周期的CPR分别为51.1%(46/90)和48.4%(44/91)[OR(95%CI)1.11(0.59-2.08),P=0.710]。迄今为止,观察到的CLBR为73.3%(66/90)和67.0%(61/91)(P=0.354),分别。在每一组中,没有活产的7例患者剩余的囊胚被冷冻。意向治疗组的CPR分别为38.3%和38.6%[OR(95%CI)0.98(0.56-1.73),P=0.967],分别,在36.6°C与37.1°C下培养。
结论:只有选定的预期预后良好的患者才有资格参加本研究。
结论:胚胎在培养至胚泡期期间倾向于耐受温度偏差的微小变化,在两个略微不同的温度下,它们具有相似的植入潜力。
背景:没有资金或利益冲突需要申报。
背景:NCT03548532。
■2017年10月23日。
■2017年11月10日。
OBJECTIVE: Is there a difference in clinical pregnancy rates (CPRs) in good prognosis patients after single embryo transfer (SET) on Day 5, in case of stable culture at 36.6°C or 37.1°C?
CONCLUSIONS: CPR (with heartbeat at 7 weeks) after blastocyst transfer do not differ after culturing at 36.6°C or 37.1°C.
BACKGROUND: Since the beginning of IVF, embryo culture has been performed at 37.0°C; however, the optimal culture temperature remains unknown. Changes in incubator types have led to significant improvements in temperature control. Stable temperature control, i.e. with temperature differences of max. 0.1°C between chambers, is possible in some incubators. A previous prospective pilot study showed that embryo development on Day 5/6 was not affected when embryos were cultured at a stable temperature of 36.6°C or 37.1°C, but culture at 37.1°C resulted in an increased CPR when compared to culture at 36.6°C (74.2% vs 46.4%).
METHODS: A prospective randomized controlled trial was performed in a tertiary fertility centre between February 2017 and November 26, 2022. A sample size of 89/89 patients with fresh single embryo transfer (SET) was required to achieve 80% power to detect a difference of 0.22 between group proportions (0.43-0.65) at a significance level of 0.05 using a two-sided z-test with continuity correction.
METHODS: Patients were recruited on the day of oocyte retrieval based on inclusion criteria with final randomization after denudation once six mature oocytes were present. The primary endpoint was CPR (heartbeat at 7 weeks); secondary endpoints were fertilization rate, blastocyst development, biochemical pregnancy rate, live birth rate (LBR), and cumulative live birth rate (CLBR).
RESULTS: A total of 304 patients were eligible for the study; of these 268 signed the consent, 234 (intention-to-treat) were randomized and 181 (per-protocol) received a SET on Day 5: 90 received culture at 36.6°C and 91 at 37.1°C. Patients were on average 32.4 ± 3.5 versus 32.5 ± 4.2 years old, respectively. No differences were observed in embryological outcomes per cycle between culture at 36.6°C versus 37.1°C: 12.0 ± 3.8 vs 12.1 ± 3.8 COCs retrieved (P = 0.88), 10.0 ± 3.1 versus 9.9 ± 2.9 mature oocytes inseminated (P = 0.68), with a maturation rate of 84.2% (901/1083) versus 83.5% (898/1104) (P = 0.87); and 8.0 ± 3.1 versus 7.9 ± 2.7 normally fertilized oocytes with a fertilization rate of 79.7% (720/901) vs 80.5% (718/898) (P = 0.96), respectively. On average 1.5 ± 1.7 versus 1.4 ± 1.9 (P = 0.25) and 1.1 ± 1.1 versus 0.9 ± 1.0 (P = 0.45) supernumerary blastocysts were vitrified on Day 5 and Day 6, respectively. The utilization rate per fertilized oocyte was 46.1% vs 41.5% (P = 0.14). A SET was performed for 181 patients, leading to a biochemical pregnancy rate of 72.2% (65/90) versus 62.7% (57/91) (P = 0.17), respectively. The CPR per fresh transfer cycle was 51.1% (46/90) versus 48.4% (44/91) [OR (95% CI) 1.11 (0.59-2.08), P = 0.710]. To date, a CLBR of 73.3% (66/90) versus 67.0% (61/91) (P = 0.354) has been observed, respectively. In each group, seven patients without live birth have remaining blastocysts frozen. The CPR for the intention-to-treat groups were 38.3% vs 38.6% [OR (95% CI) 0.98 (0.56-1.73), P = 0.967], respectively, for culture at 36.6°C versus 37.1°C.
CONCLUSIONS: Only selected patients with expected good prognosis were eligible for the study.
CONCLUSIONS: Embryos tend to tolerate small changes in temperature deviations during culture to the blastocyst stage, as demonstrated by their similar implantation potential at two slightly different temperatures.
BACKGROUND: There is no funding or conflicts of interest to declare.
BACKGROUND: NCT03548532.
UNASSIGNED: 23 October 2017.
UNASSIGNED: 10 November 2017.