Humanitas Fertility Center, Department of Gynaecology, Division of Gynaecology and Reproductive Medicine, Humanitas Research Hospital, 20084, Rozzano, Milan, Italy.
Department of Obstetrics, Gynaecology and Reproductive Sciences, School of Medicine, Yale University, New Haven, CT, USA.
J Assist Reprod Genet. 2018 Mar;35(3):457-465. doi: 10.1007/s10815-017-1092-2. Epub 2017 Nov 22.
Is there a difference in implantation and pregnancy rates between embryos transferred electively at cleavage or blastocyst stage in infertile women ≤ 38 years with at least four zygotes on day 1 post retrieval?
A randomized clinical trial was conducted in a single tertiary care hospital with a sample size of 194 patients in each arm for a total population of 388 women. Patients less than 39 years of age with more than three fertilized oocytes and less than four previous assisted reproductive technology (ART) attempts were inclusion criteria.
The two groups were similar for age, years of infertility, indication to treatment, basal antimüllerian hormone and FSH, number of previous ART cycles, primary or secondary infertility, type of induction protocol, days of stimulation, total gonadotrophin dose, and estradiol (E2) and progesterone (P) levels at trigger. No statistically significant differences were found in terms of number of retrieved oocytes, inseminated oocytes, fertilization rate, canceled transfers (7.73% in blastocyst and 3.61% in cleavage stage group), and cycles with frozen embryos and/or oocytes. Although a higher number of fertilized oocytes were in the blastocyst stage group (6.18 ± 1.46 vs 5.89 ± 1.54, p = 0.052), a statistically greater number of embryos/randomized cycle were transferred at cleavage stage (1.93 ± 0.371) compared with the number of transferred blastocysts (1.80 ± 0.56), probably due to the number of embryos not reaching blastocyst stage (3.09%). The implantation rate (28.37 vs 25.67%), pregnancy rate per cycle (36.06 vs38.66%), transfer (39.66 vs 40.11%), spontaneous abortions (19.72% vs 12.00%), delivery rate per cycle (27.84 vs 32.99%), and transfer (30.17 vs 34.22%) were not significantly different between the blastocyst and cleavage stage groups. The twin delivery rate was higher in the blastocyst stage group, although not significant (42.59 vs 28.12%). The mean numbers of frozen blastocyst (2.30 ± 1.40 vs 2.02 ± 1.00) and frozen oocytes (7.09 ± 3.55vs 6.79 ± 3.26) were not significantly different between the two groups.
Fresh blastocyst-stage transfer versus cleavage-stage transfer did not show any significant difference in terms of implantation and pregnancy rate in this selected group of patients. A high twin delivery rate in both groups (35.59%) was registered, and although not significant, they were higher in the blastocyst transfer group (42.59 vs 28.12%). Our conclusion supports considering single embryo transfer (SET) policy, even in cleavage stage in patients younger than 39 years with at least four zygotes.
ClinicalTrials.gov registration number NCT02639000.
在≤38 岁且至少有 4 个取卵日 1 天的受精卵的不孕女性中,与卵裂期相比,在囊胚期选择性移植胚胎是否会导致着床率和妊娠率的差异?
在一家单中心三级医院进行了一项随机临床试验,每个臂的样本量为 194 例患者,总人数为 388 例女性。纳入标准为年龄<39 岁,受精卵数>3 个,辅助生殖技术(ART)尝试次数<4 次。
两组患者的年龄、不孕年限、治疗指征、基础抗苗勒管激素和 FSH、既往 ART 周期数、原发或继发不孕、诱导方案类型、刺激天数、总促性腺激素剂量以及扳机日雌二醇(E2)和孕酮(P)水平相似。在取卵数、授精卵数、受精率、取消移植(囊胚期组 7.73%,卵裂期组 3.61%)以及冷冻胚胎和/或卵子的周期数方面无统计学差异。尽管囊胚期组有更多的受精卵(6.18±1.46 比 5.89±1.54,p=0.052),但卵裂期组移植的胚胎/随机周期数(1.93±0.371)多于囊胚期组(1.80±0.56),这可能是因为未达到囊胚期的胚胎数量较多(3.09%)。着床率(28.37%比 25.67%)、每周期妊娠率(36.06%比 38.66%)、移植率(39.66%比 40.11%)、自然流产率(19.72%比 12.00%)、每周期活产率(27.84%比 32.99%)以及移植率(30.17%比 34.22%)在囊胚期组和卵裂期组之间无显著差异。虽然差异无统计学意义,但囊胚期组的双胎分娩率较高(42.59%比 28.12%)。两组间冷冻囊胚(2.30±1.40 比 2.02±1.00)和冷冻卵母细胞(7.09±3.55 比 6.79±3.26)的平均数量无显著差异。
在这个选定的患者群体中,新鲜囊胚期移植与卵裂期移植在着床率和妊娠率方面没有显著差异。两组的双胎分娩率(35.59%)均较高,虽然差异无统计学意义,但囊胚移植组(42.59%比 28.12%)较高。我们的结论支持考虑单胚胎移植(SET)政策,即使是在 39 岁以下至少有 4 个受精卵的卵裂期患者中。
NCT02639000。