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临床试验/NCT06920797
NCT06920797已完成不适用

Evaluation of New Strategies in the Analysis of the Reproductive Tract Microbiome: A Descriptive Pilot Study

Igenomix2 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2025年6月9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
Igenomix
入组人数
57
试验地点
2
主要终点
Evaluation of minimally invasive techniques for the analysis of the endometrial microbiome

研究概览

简要总结

The goal of this observational study is to evaluate alternative less invasive sampling methods for the analysis of the endometrial microbiome. For that, vaginal swab and endometrial fluid samples will be assessed in comparison with the standard sampling method (an endometrial biopsy), in women aged 18-50 years on an oocyte donation program and/or who attend the clinic for routine gynecological controls, and whose samples will be collected during the secretory phase of a natural menstrual cycle. The study aims to:

  • Evaluate the pontential of the less invasive techniques to assess the endometrial microbiome, compared to the endometrial biopsy, as well as their safety.
  • Evaluate the microbiome's stability in a period of 1 to 3 months.

Participants will undergo a sampling round (of the 3 sampling methods), and then a second round 1, 2 or 3 months later, as assigned by the investigator.

详细描述

The endometrium plays a pivotal role in reproductive health, influencing processes such as implantation and pregnancy. Although the endometrium has generally been considered a tissue free of bacteria, numerous studies have documented the presence of an endometrial microbiome mainly composed of different species from the Lactobacillus genus. The presence of pathogenic bacteria has been shown to disrupt the uterine environment, affecting implantation rates and pregnancy success.

Traditional and emerging sampling methods allow for the study of the microbial profile of the endometrium, but the efficiency and representativeness of these techniques vary. Therefore, this study aims to compare the effectiveness, accuracy, and usefulness of three different sampling methods for microbiome analysis: endometrial biopsy, endometrial fluid, and vaginal swab. Additionally, it seeks to compare the endometrial microbial profiles with the vaginal microbiome to assess whether it may provide indirect information about the upper reproductive tract.

Endometrial biopsy is a gynecological procedure routinely performed in the clinical practice to provide the patient with an analysis of their microbiome before embryo transfer, ensuring that it is carried out in a non-pathological endometrium, especially in patients with previous implantation failures. It is considered the standard for uterine lining sampling but is an invasive technique that, due to the discomfort associated with the procedure itself, may not always be feasible. Endometrial fluid is a less invasive method that offers a potential alternative by collecting cells from the endometrial surface. On the other hand, studying the vaginal microbiome, although it may provide insight into reproductive outcomes, may not accurately reflect the microbiome of the uterine cavity, a key location where implantation and pregnancy occur. By using comprehensive microbiome analysis techniques, this study will assess the microbial populations collected by each method and determine the efficiency and usefulness of each sampling technique.

Through direct comparison, this research aims to establish a clearer understanding of how sampling techniques can impact microbiome analysis in the context of reproductive health. The results obtained could have significant implications for clinical practice, potentially offering less invasive and more accurate methods to evaluate the endometrial microbiome. This study aims not only to redirect our approach to sampling the endometrial microbiome but also to improve our understanding of its role in female reproductive health. Furthermore, it would facilitate the assessment of potential correlations between the endometrial and vaginal microbiomes.

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
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women, between 18 and 50 years, coming form the donor program and/or patients from the General Gynaecology Unit who attend to routine gynaecological controls to the clinic and who voluntarily accept to participate and sign the corresponding informed consent approved by the Ethics Committee, once they have been dully informed of the study's nature and knoe the potential risks, benefits and discomforts.

排除标准

  • Ongoing pregnancy.
  • Samples not obtained during the secretory phase of a natural cycle.
  • Intake of any antibiotic, probiotic and/or antifungal in the 7 days prior to the sample collection of the first cycle.

研究组 & 干预措施

Endometrial and vaginal microbiome description

Participants in this group will undergo two rounds of samples collection, 1, 2 or 3 months apart, as assigned by the investigator.

干预措施: Reproductive tract microbiome analysis (Diagnostic Test)

结局指标

主要结局

Evaluation of minimally invasive techniques for the analysis of the endometrial microbiome

时间窗: From enrollment to the second sampling round (1 to 3 months, depending on the study assigned group))

Assessment of the viability and technical reliability of the new sampling techniques (endometrial fluid -EF- and vaginal swab -VS-) to evaluate the endometrial microbiome, compared with the standard sampling technique, the endometrial biopsy - EB-. The endometrial microbiome composition will be determined by DNA extraction and bacterial profiling from the three samples (endometrial biopsy -EB-, endometrial fluid -EF- and vaginal swab -VS-). The EB microbiome will serve as reference and it will be compared with the EF's and VS's microbiome to determine whether they are equivalent.

次要结局

  • Safety evaluation of the sampling techniques (EB, EF and VS)(From enrollment to the end of the study (from 1 to 3 months, depending on the assigned group))
  • Evaluation of the inter-cycle consistency of the microbial profile in a period of 1 to 3 months(From enrollment to the second sampling round (1 to 3 months, depending on the study assigned group)))

研究者

发起方
Igenomix
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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