Madjunkov Mitko, Sharma Prati, Baratz Ari, Glass Karen, Abramov Rina, Logan Nicole, Madjunkova Svetlana, Librach Clifford
CReATe Fertility Centre, Toronto, Ontario, Canada; Department of Obstetrics and Gynecology, University of Toronto, Toronto, Ontario, Canada.
CReATe Fertility Centre, Toronto, Ontario, Canada.
Fertil Steril. 2024 Dec;122(6):1105-1113. doi: 10.1016/j.fertnstert.2024.07.029. Epub 2024 Jul 27.
To evaluate the positive predictive value (PPV) of prenatal cell-free DNA (cfDNA) screening for chromosomal aneuploidies in pregnancies achieved either after single euploid transfer in in vitro fertilization or Preimplantation Genetic Testing for Aneuploidy (PGT-A) cycles or transfer of single untested embryo, and to assess the concordance of prenatal-cfDNA-screening and PGT-A results.
Single center retrospective cohort study.
Fertility clinic.
PATIENT(S): A total of 2,973 prenatal-cfDNA-screening results for the most common trisomies (T13, T18, T21, X, and Y) and microdeletions (1p36, 4p16.3, 5p15.2, 15q11.2, and 22q11.2) from singleton pregnancies allocated into two groups: PGT-A group (n = 1,204) pregnant after single euploid transfer and non-PGT-A group (n = 1769) pregnant after transfer of single untested embryo, between 2016 and 2023.
INTERVENTION(S): Not applicable.
MAIN OUTCOME MEASURE(S): The primary outcome measure was the accuracy of prenatal-cfDNA screening. Positive and negative prenatal-cfDNA-screening results and subsequent prenatal or postnatal diagnostic testing were used to classify each positive prenatal-cfDNA-screening result as a true or a false positive. Secondary endpoints were to evaluate the concordance of PGT-A and prenatal-cfDNA-screening results and to assess the differences in the fetal fraction of cfDNA used for prenatal-cfDNA-screening reports between the study groups.
RESULT(S): Prenatal-cfDNA screening was performed at a mean 11.3 ± 1.8 weeks gestational age, and yielded results in 99.9% of the patients (0.1% cancellation rate). There was no difference in the fetal fraction between PGT-A tested and not tested pregnancies (9.5% ± 4% vs. 10.3% ± 4%). 13 positive prenatal-cfDNA-screening results (two T21, two X0, four XXX, one XYY, one indeterminate sex, two 22q11 del/dup, and one 15q11.2del) were received for PGT-A group. Only one (22q11 dup) was confirmed with amniocentesis and fetal autopsy, giving a PPV for an abnormal prenatal-cfDNA screening of 7.7%, the rest had results concordant with PGT-A. Sex chromosomes were 100% concordant between prenatal-cfDNA-screening and PGT-A results, giving a 100% PPV for PGT-A for sex chromosomes and 100% negative predictive value for aneuploidies. Positive prenatal-cfDNA-screening results were received for 27 pregnancies from untested embryos (1.5%), follow-up testing was electively performed for 21, and 8 had confirmed the prenatal-cfDNA-screening result, giving a PPV for the non-PGT-A group of 38%.
CONCLUSION(S): This study demonstrates that patients undergoing in vitro fertilization/PGT-A and single euploid embryo transfer can reliably do prenatal-cfDNA screening during their first trimester. Fetal fraction in singleton pregnancies after PGT-A tested embryos is not different from pregnancies with untested embryos. Positive predictive value for an abnormal prenatal-cfDNA-screening result after euploid embryo transfer was reassuringly low (7.7%). PGT-A reliably selects against aneuploidy with 100% concordance with fetal sex.
评估在体外受精单倍体胚胎移植或植入前非整倍体基因检测(PGT-A)周期后受孕,或单未检测胚胎移植后的妊娠中,无创产前游离DNA(cfDNA)筛查染色体非整倍体的阳性预测值(PPV),并评估无创产前cfDNA筛查与PGT-A结果的一致性。
单中心回顾性队列研究。
生殖医学中心。
共纳入2973例单胎妊娠的无创产前cfDNA筛查结果,这些妊娠针对最常见的三体综合征(T13、T18、T21、X和Y)及微缺失(1p36、4p16.3、5p15.2、15q11.2和22q11.2)分为两组:PGT-A组(n = 1204),为单倍体胚胎移植后受孕;非PGT-A组(n = 1769),为单未检测胚胎移植后受孕,时间跨度为2016年至2023年。
不适用。
主要观察指标为无创产前cfDNA筛查的准确性。根据无创产前cfDNA筛查的阳性和阴性结果以及随后的产前或产后诊断检测,将每个阳性无创产前cfDNA筛查结果分类为真阳性或假阳性。次要终点是评估PGT-A与无创产前cfDNA筛查结果的一致性,并评估研究组之间用于无创产前cfDNA筛查报告的cfDNA胎儿分数差异。
无创产前cfDNA筛查在平均孕龄11.3±1.8周时进行,99.9%的患者获得了结果(取消率0.1%)。PGT-A检测和未检测妊娠的胎儿分数无差异(9.5%±4%对10.3%±4%)。PGT-A组有13例无创产前cfDNA筛查结果为阳性(2例T21、2例X0、4例XXX、1例XYY、1例性别不确定、2例22q11缺失/重复、1例15q11.2缺失)。只有1例(22q11重复)经羊膜穿刺术和胎儿尸检证实,异常无创产前cfDNA筛查的PPV为7.7%,其余结果与PGT-A一致。无创产前cfDNA筛查与PGT-A结果在性染色体方面100%一致,PGT-A对性染色体的PPV为100%,非整倍体的阴性预测值为100%。未检测胚胎的妊娠中有27例(1.5%)无创产前cfDNA筛查结果为阳性,21例进行了选择性随访检测,8例证实了无创产前cfDNA筛查结果,非PGT-A组的PPV为38%。
本研究表明,接受体外受精/PGT-A和单倍体胚胎移植的患者在孕早期可可靠地进行无创产前cfDNA筛查。PGT-A检测胚胎后的单胎妊娠胎儿分数与未检测胚胎的妊娠无差异。整倍体胚胎移植后异常无创产前cfDNA筛查结果的阳性预测值低得令人放心(7.7%)。PGT-A能可靠地筛选出非整倍体,与胎儿性别100%一致。