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临床试验/NCT03319654
NCT03319654已完成不适用

Impact of DNA Fragmentation in Sperm on Pregnancy Outcome After Intra-uterine Insemination in a Spontaneous Cycle

University Hospital, Antwerp2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2017年10月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
2
主要终点
DNA Fragmentation as a Predictor of Live Birth Rate

研究概览

简要总结

Infertility affects about 10% of all couples and is defined by a failure to achieve a clinical pregnancy within a year of regular unprotected sexual intercourse. Up to one third of these couples will not have an identifiable cause after routine investigation, id est idiopathic infertility. The current diagnosis of male infertility relies on the World Health Organization (WHO) 2010 criteria which focus on concentration, motility and morphology in comparison to cut-off values of a fertile population. Alas, the relevance of the conventional semen analysis for the choice of treatment and the predictive value for an infertile couple with idiopathic or mild male infertility embarking on medically assisted reproduction (MAR) remains questionable. In other words, there is a strong clinical need to distinguish fertile from infertile men through new sperm function testing and to be able to select both the patient population who will benefit from MAR as well as the type of treatment.

Numerous studies utilizing different techniques for assessing sperm DNA fragmentation support the existence of a significant association between sperm DNA damage and pregnancy outcomes.

In this prospective cohort study the investigators aim to study the role of sperm DNA fragmentation analysis in selecting the patient who will benefit from intra-uterine insemination (IUI) therapy since IUI is still considered the first step in MAR and is performed at a large scale in Belgium and worldwide.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Couples seeking fertility treatment after at least 12 months of unprotected intercourse are eligible. All couples underwent basic fertility investigations which included semen analysis, evaluation of menstrual cycle, and tubal patency testing.

排除标准

  • Double sided tubal disease, severe endometriosis (classified as revised American Society for Reproductive Medicine stage III or IV), premature ovarian failure, and known endocrine disorders (such as Cushing's syndrome or adrenal hyperplasia), azoö- or necrozoospermia

结局指标

主要结局

DNA Fragmentation as a Predictor of Live Birth Rate

时间窗: up to 36 months

The odds ratio on live birth per unit increase in % total Sperm DNA Fragmentation of the diagnostic sample.

次要结局

  • % SDF in the Total Fraction After Density Gradient in the Diagnostic Sample (Pre-IUI)(up to 3 months)
  • % SDF in the Vital Fraction After Density Gradient in the Diagnostic Sample (Pre-IUI)(up to 3 months)
  • % SDF in the Total Fraction in the Ejaculate of the IUI- Sample(36 months)
  • % SDF in the Vital Fraction in the Ejaculate of the IUI- Sample(36 months)
  • % SDF in the Total Fraction After Density Gradient in the IUI Sample(36 months)
  • % SDF in the Vital Fraction After Density Gradient in the IUI Sample(36 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alessa Sugihara

ASugihara

University Hospital, Antwerp

研究点 (2)

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