Correlation Of Clinical Outcomes After Transfer Of Good-Quality Morphology Embryos In Patients With A Favorable Prognosis And Non-Invasive Preimplantation Genetic Testing For Aneuploidy (NiPGT-A) Results
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Ongoing Pregnancy/Live Birth Rate by NiPGT-A Result Groups
研究概览
简要总结
Non-invasive preimplantation genetic testing for aneuploidy (NiPGT-A) is an emerging approach that analyzes embryonic cell-free DNA (cfDNA) released into the spent culture medium (SCM) to assess chromosomal status without performing trophectoderm biopsy. This technique has the potential to reduce procedural invasiveness and eliminate biopsy-related risks while providing additional information for embryo selection in assisted reproductive technology (ART). However, the clinical value of NiPGT-A remains uncertain because available evidence is limited and largely derived from observational studies, with few studies reporting live birth outcomes.
This prospective observational study aims to evaluate the correlation between NiPGT-A results and clinical outcomes after single blastocyst transfer in patients with a favorable prognosis undergoing IVF/ICSI treatment. In this study, embryos with good morphological quality will undergo non-invasive sampling of spent culture medium for cfDNA analysis. NiPGT-A results will be categorized into four groups: no result, euploid, mosaic, and aneuploid. The study will compare pregnancy and birth outcomes across these groups to determine the clinical utility of NiPGT-A in embryo selection strategies.
详细描述
Background and Rationale:
Preimplantation genetic testing for aneuploidy (PGT-A) using trophectoderm biopsy has been widely used in IVF to improve embryo selection. However, the invasive nature of embryo biopsy raises concerns about potential impacts on embryo viability and limits its routine use in certain patient populations. Non-invasive preimplantation genetic testing for aneuploidy (NiPGT-A) has been proposed as an alternative approach that analyzes cell-free DNA (cfDNA) released by the embryo into the spent culture medium (SCM) during in vitro development.
Several studies have demonstrated that cfDNA in SCM can reflect embryonic chromosomal status, but the concordance between NiPGT-A results and trophectoderm biopsy remains variable and influenced by factors such as sampling timing, maternal DNA contamination, embryo mosaicism, and laboratory protocols. Additionally, cases have been reported where embryos classified as aneuploid by NiPGT-A resulted in healthy live births, raising concerns about potential misclassification and highlighting the need for further clinical validation.
Recent research has suggested that NiPGT-A may be more valuable when used as a complementary tool to embryo morphology rather than as a direct replacement for biopsy-based PGT-A. Some studies have also reported that embryos with low or undetectable cfDNA levels in the culture medium may have favorable developmental potential, suggesting that cfDNA characteristics themselves could be associated with embryo viability.
Given the limited clinical evidence, particularly regarding live birth outcomes, further prospective studies are needed to clarify the relationship between NiPGT-A results and reproductive outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 34 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women undergoing in vitro fertilization (IVF) with intracytoplasmic sperm injection (ICSI).
- •Age younger than 35 years at the time of oocyte retrieval.
- •Good ovarian response, defined as having at least four good-quality embryos (Grade 1 or Grade 2) on Day 3 or later.
- •Undergoing the first or second IVF cycle.
- •Normal semen parameters of the male partner.
- •Willing to undergo non-invasive preimplantation genetic testing for aneuploidy (NiPGT-A) using spent embryo culture media.
- •Agree to vitrification of a single morphologically best-quality blastocyst and to undergo frozen single embryo transfer.
- •Able and willing to provide written informed consent.
排除标准
- •Presence of untreated uterine abnormalities, including uterine malformations or significant intrauterine pathology.
- •History of uterine surgery.
- •History of ovarian surgery.
- •Known metabolic disorders.
- •Use of donor oocytes.
- •In vitro maturation (IVM) cycles.
- •Participation in another clinical study during the study period.
- •Patients who do not undergo frozen single embryo transfer.
研究组 & 干预措施
No Result (WGA Failure) NiPGT -A
Embryos classified as having no NiPGT-A result due to unsuccessful whole genome amplification (WGA) of cell-free DNA obtained from the spent culture medium. These embryos are selected for transfer based solely on morphological assessment. Clinical outcomes after single frozen embryo transfer will be evaluated in this group.
Euploid NiPGT-A
Embryos classified as euploid based on NiPGT-A analysis of cell-free DNA obtained from the spent culture medium. Embryo selection for transfer is based only on morphological criteria according to routine clinical practice, and NiPGT-A results are blinded during treatment. Clinical outcomes will be compared with other NiPGT-A result groups.
Mosaic NiPGT-A
Embryos classified as mosaic according to NiPGT-A analysis of cell-free DNA from the spent culture medium. As in other groups, embryo transfer decisions are based solely on morphological evaluation, and NiPGT-A results are not used for clinical decision-making during the study.
Aneuploid NiPGT-A
Embryos classified as aneuploid according to NiPGT-A analysis of cell-free DNA obtained from the spent culture medium. Embryos included in this cohort are transferred based on morphological assessment without knowledge of NiPGT-A results. Clinical outcomes will be analyzed and compared with other groups.
结局指标
主要结局
Ongoing Pregnancy/Live Birth Rate by NiPGT-A Result Groups
时间窗: Up to 12 weeks
Presence of at least one intrauterine gestational sac with fetal cardiac activity confirmed by ultrasound at 12 weeks' gestation.
次要结局
- Positive Beta-hCG Rate by NiPGT-A Result Groups(At 2 weeks after embryo placement)
- Clinical Pregnancy Rate by NiPGT-A Result Groups(At 7 weeks' gestation)
- Miscarriage Rate by NiPGT-A Result Groups(At 20 weeks of gestation)