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临床试验/NCT06243913
NCT06243913已完成不适用

Analysis of Reproductive Outcomes Obtained in Patients Undergoing Intrauterine Insemination with Donor Sperm Previously Vitrified - Pilot Study

Clínica EUGIN1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年12月20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
30
试验地点
1
主要终点
Clinical pregnancy rate

研究概览

简要总结

The aim of this study is to assess the evaluate the effectiveness of vitrified donor semen in intrauterine insemination treatments.

详细描述

Sperm cryopreservation is an efficient procedure widely used in fertility clinics, that provides logistical flexibility and increases the potential for success in assisted reproduction. It has been demonstrated that reproductive rates are comparable when using frozen sperm or fresh semen. However, sperm freezing using standard protocols is inevitably associated with a loss of motility, membrane integrity, and other post-thaw sperm quality parameters due to what is known as cryodamage, which involves the formation of intracellular ice crystals, osmotic shock, and dehydration.

Sperm vitrification has been recently developed as an improved alternative, where freezing occurs extremely rapidly (-20,000 ºC/min). Consequently, the formation of intracellular ice crystals is reduced, leading to improvements in sperm motility, vitality, and integrity.

However, the use of vitrified semen in fertility clinics is scarce, and no study has addressed whether vitrification could affect reproductive outcomes, such as live birth.

The aim of this study is to assess the evaluate the effectiveness of vitrified donor semen in intrauterine insemination treatments through the analysis of clinical pregnancy (primary objective) and as secondary objectives the number of progressive sperm post-thaw, percentage of progressive sperm and biochemical pregnancy.

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 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing Artificial Insemination with sperm from donor.
  • Female partner's age < 35 years
  • First IUI attempt
  • Caucasian phenotype

排除标准

  • Any adverse medical condition that may significantly affect reproductive outcomes

结局指标

主要结局

Clinical pregnancy rate

时间窗: 7 weeks after procedure

Fetal heartbeat observed in the 7th week of gestation.

次要结局

  • Percentage of sperm progressive motility(Day of procedure)
  • Biochemical pregnancy rate(14 days after procedure)
  • Total number of sperm with progressive motility(Day of procedure)

研究者

发起方
Clínica EUGIN
申办方类型
Other
责任方
Sponsor

研究点 (1)

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