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临床试验/NCT03669276
NCT03669276已完成不适用

Effect of Gonadotropin Types and Indications on Homologous Intrauterine Insemination Success: A Study From 1251 Cycles and a Review of the Literature

Centre Hospitalier Universitaire, Amiens1 个研究点 分布在 1 个国家目标入组 1,251 人开始时间: 2014年8月1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
1,251
试验地点
1
主要终点
Success factors in the ovarian stimulation

研究概览

简要总结

In this study the investigators took the opportunity of having a large sample of IUI cycles in a single centre to try to analyse the effect of stimulation protocols and of the infertility origin on the results, taking in account the main confounding variables (female age, IUI attempt rank, and sperm quality) on the clinical outcome.

All couples had undergone a standard infertility evaluation, which included medical history, physical examination, and assessment of tubal patency by either hysterosalpingography or laparoscopy and hormonal analysis on cycle day 3. A transvaginal ultrasound scan was performed on the second day of the cycle. On the same day, ovarian stimulation was carried out with recombinant FSH (follitropinrFSH; Gonal-F, MerckSerono, France, orfollitropin;Puregon, MSD, France), urinary FSH (urofollitropin, Fostimon, France), orhMG (menotropin, Menopur, France) atastarting dose of 75 IU/day from the second day of the cycle.

The main clinical outcome measures were clinical pregnancy and live-birth rates per cycle. Clinical pregnancy was defined as the evidence of pregnancy by ultrasound examination of the gestational sac at weeks 5-7.

详细描述

Many studies have evaluated the predictive factors of IUI clinical outcomes, including the female's age, the infertility duration, the rank of the attempt, and the sperm parameters [10-16]. However, few studies have compared the pregnancy rates based on the used COS or on the infertility type.

In this study the investigators took the opportunity of having a large sample of IUI cycles in a single centre to try to analyse the effect of stimulation protocols and of the infertility origin on the results, taking in account the main confounding variables (female age, IUI attempt rank, and sperm quality) on the clinical outcome.

All couples had undergone a standard infertility evaluation, which included medical history, physical examination, and assessment of tubal patency by either hysterosalpingography or laparoscopy and hormonal analysis on cycle day 3. A transvaginal ultrasound scan was performed on the second day of the cycle. On the same day, ovarian stimulation was carried out with recombinant FSH (follitropinrFSH; Gonal-F, MerckSerono, France, orfollitropin;Puregon, MSD, France), urinary FSH (urofollitropin, Fostimon, France), orhMG (menotropin, Menopur, France) atastarting dose of 75 IU/day from the second day of the cycle.

The main clinical outcome measures were clinical pregnancy and live-birth rates per cycle. Clinical pregnancy was defined as the evidence of pregnancy by ultrasound examination of the gestational sac at weeks 5-7.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
20 Years 至 44 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • women with a failure to conceive after, ≥12 months of unprotected and regular intercourse,
  • aged 20-44 years
  • with normal ovulation reserve (basal follicle- stimulating hormone (FSH) level < 10 IU/l and estradiol (E2) level < 30ng/mL);
  • theirpartnershadtohaveatotal motile sperm (TMS) count of>1×106.

排除标准

  • TMS ≤1×106;
  • sperm donation;
  • seropositivity for human immunodeficiency virus (HIV) for any couple member;
  • inseminations performed in a natural cycle or with clomiphene citrate (CC)

结局指标

主要结局

Success factors in the ovarian stimulation

时间窗: 7 years

The objective of this study is to evaluate the level of success factors of intrauterine insemination (IUI) in controlled ovarian stimulation (COS) in order to define the type of infertility. This retrospective cohort study included 1251 couples undergoing homologous IUIs.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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