NCT05966883进行中（未招募）不适用
SpermQT Prospective Observational Trial
Inherent Biosciences6 个研究点 分布在 1 个国家目标入组 1,000 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
- 进行中（未招募）
- 发起方
- 入组人数
- 1,000
- 试验地点
- 6
- 主要终点
- Number of patients that have and have not achieved pregnancy during rounds 1 and 2 of intrauterine insemination (IUI)
研究概览
简要总结
The goal of the study is to validate the ability of the Epigenetic Sperm Quality Test (SpermQT) to assess a man's sperm quality and corresponding success of infertility treatments.
详细描述
This prospective study will consist of analyzing a man's semen sample to determine the patient's SpermQT score and following the success of each fertility treatment to produce a pregnancy and live birth. Physicians and patients will be blinded to SpermQT results.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subjects have been recommended to pursue IUI, or they have recently completed an IUI (regardless of outcome)
- •Male partner is under 45 years of age
- •Female partner is under 38 years of age
- •The total motile sperm count from the raw semen analysis must be greater than or equal to 10 million
排除标准
- •The female or male partner have a BMI equal to or greater than 40
- •The male partner has undergone male testosterone replacement therapy in the last 6 months
- •Either the female or male partner have a history of recurrent pregnancy loss, defined as 2 or more consecutive clinical/ultrasound pregnancy losses
- •There are any known factors contributing to female factor infertility, such as but not limited to:
- •Severe Endometriosis (stage 3 or higher, endometrioma on ovaries)
- •Multiple uterine fibroids 5cm or larger
- •Severe Asherman's Syndrome
- •Severe Mullerian anomaly
- •Lack of tubal patency in at least one fallopian tubes
结局指标
主要结局
Number of patients that have and have not achieved pregnancy during rounds 1 and 2 of intrauterine insemination (IUI)
时间窗: 6 months
Number of patients that have and have not achieved pregnancy during rounds 1 and 2 of IUI in each bracket of SpermQT score (Poor, Normal, and Excellent)
次要结局
- Number of patients that have and have not achieved a live birth(18 months)
- Number of patients that have and have not achieved pregnancy during subsequent rounds of intrauterine insemination (IUI) and in vitro fertilization (IVF)(18 months)
研究者
研究点 (6)
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