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临床试验/NCT05173038
NCT05173038尚未招募不适用

Sun Yat-sen Memorial Hospital

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 410 人开始时间: 2022年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
410
试验地点
1
主要终点
pregnacy rate

研究概览

简要总结

The WHO operation specification requires men to maintain a 2-7-day ejaculation abstinence period before semen examination, but it does not mention the possibility of obtaining a second sample immediately after the first sample for evaluation, and the significance of the evaluation of the second sample for fertility. There is a certain fluctuation level in sperm concentration detection. Patients with normal previous detection may have lower sperm concentration on the day of IUI, resulting in the trouble of canceling IUI. It is not clear whether patients with previous oligospermia can obtain more sperm with better vitality and improve the success rate of IUI by taking sperm again. Some retrospective studies found that when the semen abstinence period of oligozoospermia men was as short as 40 minutes, the changes of sperm motility and sperm concentration were significantly improved, but there was no difference in the conclusions of other studies. A small number of assisted reproduction studies found that IUI with samples obtained during abstinence period of less than 2 days could obtain better pregnancy rate. However, the quality and sample size of these retrospective studies are limited, the repeatability is not good enough, and the conclusions are still controversial. We designed a randomized controlled study. Semen examination was performed after sperm extraction. If the sperm concentration after treatment was less than 10m, the subjects were included in the study. They were randomly divided into two groups. Group 1 received IUI for pregnancy assistance directly, and group 2 received IUI for pregnancy assistance 1 hour after the first sperm extraction. The two semen were mixed and treated. 205 subjects were included in the two groups. We tried to explore whether secondary sperm extraction in patients with low IUI concentration can improve the success rate of IUI 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
22 Years 至 80 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Male infertility (primary or secondary infertility)
  • Age 22 ~ 80 years old;
  • Body mass index < 30 kg / m2;
  • Normal levels of FSH, LH, t and PRL;
  • Semen concentration and vitality were normal or slightly abnormal (TSC ≥ 10 million / ml, PR ≥ 20%, vitality ≥ 30%), which was consistent with the indication of IUI assisted pregnancy;
  • On the day of IUI, the male side took the semen and the TSC was less than 10m / ml
  • Women's standard
  • Age 20 ~ 40 years old
  • Body mass index < 30 kg / m2;
  • 3)FSH<10U/L、AMH>1.1ng/ml
  • Bilateral fallopian tubes are unobstructed

排除标准

  • It has performed vasectomy, orchitis, unilateral orchiectomy, ejaculation difficulty, retrograde ejaculation, diabetes, cardiovascular disease, drug treatment of psychological or genetic diseases.
  • Previous history of intrauterine adhesion;
  • Hydrosalpinx;
  • B-ultrasound suggests that endometriosis cyst may be;

结局指标

主要结局

pregnacy rate

时间窗: 2021-8-20~2024.12.30

次要结局

  • proportion of immobile sperm(2021-8-20~2024.12.30)
  • Semen concentration(2021-8-20~2024.12.30)
  • Abortion rate(2021-8-20~2024.12.30)
  • forward movement rate(2021-8-20~2024.12.30)
  • semen volume(2021-8-20~2024.12.30)
  • non forward movement rate(2021-8-20~2024.12.30)
  • total number of motile sperm after treatment.(2021-8-20~2024.12.30)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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