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临床试验/NCT06165484
NCT06165484尚未招募不适用

Evaluation of Patients of Failed in Vitro Fertilization Cycle: Prospective Cohort Study

Assiut University0 个研究点目标入组 40 人开始时间: 2024年1月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
主要终点
Improving the pregnancy outcome in patients with recurrent IVF failure.

研究概览

简要总结

Current in-vitro fertilization (IVF) consumers are enjoying better success rates than early seekers, but only about a quarter of IVF cycles result in a live birth and many patients remain infertile after multiple IVF attempts. Recurrent IVF failure is distressing to patients and challenging to clinicians. Despite interventions have been proposed to improve IVF outcome after couples of failed cycles, only a few of which are evidence based.

Laparoscopy, as the gold standard for the evaluation of the pelvis, was used to be the routine procedure for many reproductive physicians. It provides information on endometriosis, tubal patency, and pelvic adhesions and a chance to fix these lesions concurrently.

详细描述

Current in-vitro fertilization (IVF) consumers are enjoying better success rates than early seekers, but only about a quarter of IVF cycles result in a live birth and many patients remain infertile after multiple IVF attempts. Recurrent IVF failure is distressing to patients and challenging to clinicians. Despite interventions have been proposed to improve IVF outcome after couples of failed cycles, only a few of which are evidence based.

Laparoscopy, as the gold standard for the evaluation of the pelvis, was used to be the routine procedure for many reproductive physicians. It provides information on endometriosis, tubal patency, and pelvic adhesions and a chance to fix these lesions concurrently.

The role of laparoscopy, especially in women whose normal screening tests suggest that pelvic pathology seem to be unlikely. However, sometimes a "normal" pelvic imaging can be misleading, since HSG or ultrasonography cannot to rule out hydrosalpinx and endometriosis completely. Furthermore, it has been shown that HSG is insufficient for predicting tubal potency for some patients with risk of pelvic adhesions, with a sensitivity between 0.0% and83% and specificity between 50% and 90%. When initial IVF treatments fail, can we offer the couples to choose additional cycle of IVF instead of evaluation of the potential peritoneal factor? In cases of otherwise so called "Unexplained infertility", the investigation cannot be considered complete until laparoscopy has been performed.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • The patients ages ranged from 20 to 40 years.
  • menstrual cycles with a duration of 24 to 38 days and no ovulatory dysfunction.
  • normal findings of pelvic ultrasonography and HSG assessment, without visible lesions that could cause implantation failure, for example: endometrial polyps, submucosal myomas, uterine septum and intrauterine adhesions.
  • hormonal values were within the normal range.
  • Semen analyses were normal according to the World Health Organization (WHO) 2010 criteria.
  • no previous surgical treatment for endometriosis; no previous oophorectomy or salpingectomy.
  • Patients included in the study had failed to conceive after at least one cycles of IVF-ET when indicated.

排除标准

  • Couples with severe male factor infertility.
  • Premature ovarian failure.
  • Patients with a poor ovarian reserve and poor responders.
  • Contraindication to laparoscopy such as mechanical or large abdominal mass (> 24 weeks gestation size).
  • Contraindication to hysteroscopy such as recent or active pelvic inflammatory disease and active uterine bleeding.

结局指标

主要结局

Improving the pregnancy outcome in patients with recurrent IVF failure.

时间窗: 1.5 YEARS

To assess if the diagnosis and treatment of pelvic or uterine pathologies with laparoscopy and hysteroscopy is of role in improving the pregnancy outcome (live birth rate and ongoing pregnancy rate) in patients with recurrent IVF failure .

次要结局

  • Abnormal laparoscopy findings and surgery-related complications(1.5 YEARS)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ali Saber Ali

Assistant Lecturer

Assiut University

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