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临床试验/NCT06231589
NCT06231589已完成不适用

Next Generation Sequencing of Embryos for Testing the Efficacy of Advanced Sperm Selection Techniques in Males With High Teratozoospermia Index

Ganin Fertility Center2 个研究点 分布在 1 个国家目标入组 264 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
264
试验地点
2
主要终点
Aneuploidy rate

研究概览

简要总结

In this study of 264 couples, sperm selection techniques in males with high teratozoospermia index and sperm DNA fragmentation significantly increased fertilization, blastocyst development rates, and maintained comparable embryo euploidy rates through preimplantation genetic testing, suggesting the efficiency of these techniques in improving assisted reproductive outcomes.

详细描述

Couples seeking infertility treatment are becoming more frequent. Paternal factor shows one of the infertility causes which may have a negative impact on reproductive outcomes. Intracytoplasmic sperm injection (ICSI) is thought to be the most effective way to treat infertility. Sperm morphology evaluation is a reliable predictor of male fertility while teratozoospermia index (TZI) is a unique expression of sperm morphological assessment. A higher rate of abnormal sperm morphology tends to have higher sperm chromosomal abnormality rates. The choice of high-quality sperm through sperm selection techniques is expected to improve ICSI outcomes. In this study, a total number of 264 couples were included and divided into 3 groups: (1) Males have normal TZI (Control group: 111 males have TZI <1.6), (2) Males with high TZI and no sperm selection techniques are performed (NO-SS group: 63 males have TZI >1.8), and (3) Males with high TZI and sperm selection techniques are performed (SS-group: 90 males have TZI >1.8). The TZI was significantly (P<0.000) higher in the NO-SS and SS-group as compared to the control group. The percentage of sperm DNA fragmentation SDF in the males of the SS group was significantly higher than the controls and NO-SS group (P=0.000). The fertilization (P=0. 039) and blastocyst development rates (P= 0. 041) are significantly higher in the SS group as compared to the NO-SS group in females aged <35. A total of 1072 embryos were tested for preimplantation genetic testing for aneuploidy using NGS, although higher SDF in the males of the SS group, the embryo euploidy rates show that there is no significant difference between the SS group (56.35±3.46%) as compared to the control group (54.54±3.24%) and the NO-SS group (57.45±4.57%). In general, we found that sperm selection techniques are efficient techniques in increasing fertilization, blastocyst development rates, and euploidy rate in males with high teratozoospermia index and sperm DNA fragmentation combined.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Males diagnosed with normal and high teratozoospermia index.
  • Males with Mild to moderate OTA (oligoteratoasthenozoospermia).
  • Males aged 18-60 years.
  • Female aged 18-40 years.
  • Case must have PGT-A for all of her blastocysts.
  • Normo responder (> 5 mature oocytes).
  • Male will have to refrain from ejaculation no less than 1 day but no greater than 3 days prior semen specimen production on day of ICSI.

排除标准

  • Leukocytospermia.
  • Presence of varicocele.
  • Known genetic abnormality.
  • Use of sperm or oocyte donors.
  • Use of gestational carrier.
  • Presence of any of the endometrial factors that affect embryo implantation such as hydrosalpings, adenomyosis or previous uterine infection.
  • Any contradictions to undergoing in vitro fertilization or gonadotropin stimulation.

结局指标

主要结局

Aneuploidy rate

时间窗: 15 days post ICSI

Defined as the proportion of aneuploid blastocysts

Fertilization rate

时间窗: 1 day

Defined as the proportion of fertilizaed oocytes

Blastocyst development rate

时间窗: 5-6 days

Defined as the proportion of blastocysts formed on day 5 or 6

Euploidy rate

时间窗: 15 days post ICSI

Defined as the proportion of euploid blastocysts

次要结局

  • Blastocyst quality rate(5-6 days)
  • Low mosaic rate(15 days post ICSI)
  • High mosaic rate(15 days post ICSI)

研究者

发起方
Ganin Fertility Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Nasreldin Abdelmagied Ali

Clinical Embryologist

Ganin Fertility Center

研究点 (2)

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