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临床试验/NCT07676682
NCT07676682已完成不适用

INVESTIGATİON OF THE EFFECT OF PASSIVE UTERINE STRAIGHTENING WITH A FULL BLADDER IN COMBINATION WITH TRANSABDOMINAL ULTRASONOGRAPHY ON PREGNANCY RATES IN INTRAUTERINE INSEMINATION: A PROSPECTIVE COHORT STUDY

Firat University1 个研究点 分布在 1 个国家目标入组 340 人开始时间: 2021年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
340
试验地点
1
主要终点
Clinical Pregnancy

研究概览

简要总结

In this prospective study, we aimed to compare the pregnancy outcomes of a classic blind IUI procedure with an empty bladder with a transabdominal ultrasound-guided IUI procedure where the cervicouterine angle was flattened by using a full bladder.

详细描述

Intrauterine artificial insemination (IUI) is a procedure in which prepared sperm is placed into the uterine cavity via a catheter to help couples undergoing treatment for unexplained infertility to conceive. Many factors influence the success of IUI. In this prospective study, we aimed to compare the pregnancy outcomes of a classic blind IUI procedure with an empty bladder with a transabdominal ultrasound-guided IUI procedure where the cervicouterine angle was flattened by using a full bladder. This prospective study was conducted at the Firat University Infertility Clinic between 2021 and November 2022. The study included a total of 340 cases diagnosed with unexplained infertility who underwent gonadotropin induction and completed the study. Group 1 (n=169) = Group that underwent blind IUI with an empty bladder, Group 2 (n=171) = Group that underwent IUI with a full bladder under transabdominal ultrasound guidance. Demographic, laboratory, radiological, ovulation induction procedure, and pregnancy outcomes were compared between the two groups. When comparing the two groups, there were no significant differences in age, body mass index (BMI), basal hormone levels, total antral and dominant follicle count, total motile sperm count, and total gonadotropin dose. The amount of insemination fluid that overflowed from the uterine cavity was significantly greater in the full bladder group than in the empty bladder group. However, clinical pregnancy rates were similar in both groups. Performing the intrauterine insemination procedure with a full bladder under transabdominal ultrasound guidance does not positively affect clinical pregnancy rates, except in terms of ease of procedure.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 39 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •The woman is aged between 18 and 39 inclusive.
  • •Cases with infertility lasting at least 12 months
  • •The presence of known medical indications for IUI.
  • •Cases with mild to moderate male factor infertility (cases with a total motile sperm count greater than 5 x 10⁶).
  • •Cases with ovulatory disorders
  • •Cases diagnosed with unexplained infertility
  • •Mixed infertility due to the known causes listed above.
  • •Patients who have started primary infertility treatment and those who have started secondary infertility treatment.
  • •Cases where ovarian stimulation was performed with gonadotropins.
  • •The ability to communicate with the couple verbally or in writing.

排除标准

  • •Cases where unilateral or bilateral tubal passage is absent
  • •Cases with acute pelvic inflammatory disease
  • •Male partners who have fewer than 1 million motile sperm in semen analysis
  • •Endometriosis.

研究组 & 干预措施

Empty bladder

In the full bladder group, patients were asked to fill their bladders by drinking water until they felt the need to urinate, thus passively flattening the uterus. Uterine flattening was determined by transabdominal ultrasonography when the angle was ≥120°.

干预措施: filling bladder (Other)

Full bladder

Patients undergoing blind IUI with an empty bladder were asked to empty their bladders by urinating prior to the procedure.

干预措施: filling bladder (Other)

结局指标

主要结局

Clinical Pregnancy

时间窗: two weeks after IUI

Women were instructed to perform a blood pregnancy test two weeks after IUI and send the result to our infertility clinic. If the result was positive, clinical pregnancy was confirmed by transvaginal ultrasound in the seventh week of amenorrhoea to verify the development of an appropriate intrauterine pregnancy.

次要结局

未报告次要终点

研究者

发起方
Firat University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mustafa YILMAZ

Prof. Dr

Firat University

研究点 (1)

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