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Plastic Detox During IVF Treatment

2026年8月31日 更新者:Abigail Mancuso

Endocrine Disrupting Chemical Detox: a Practical Method to Decrease Environmental Exposures and an Evaluation of the Impact on in Vitro Fertilization Treatment

Environmental pollutants are present in many aspects of everyday life. Exposures to common household products, such as food packaging and cookware, may affect reproductive health. Many of these environmental toxicants are known as "endocrine disrupting chemicals" because they can interfere with the body's hormone systems. Our study aims to create a guide that explains common sources of environmental toxicants and offer practical steps to reduce exposure. The investigators will evaluate how well participants understand this information and how consistently the intervention is maintained over time.

To assess whether these changes reduce environmental pollutant exposure, the investigators will measure levels of two classes of toxicants within the urine and blood at the beginning, middle and end of the study in patients struggling with infertility that are planning in vitro fertilization (IVF) treatment. The investigators will also measure the same chemicals in follicular fluid (fluid which surrounds developing eggs in the ovary) and seminal fluid (fluid which surrounds the sperm in semen) and compare these levels to samples from similar patients who did not receive the education or make environmental changes. The goal of this project is to determine whether simple changes to reduce exposure to environmental pollutants can lower chemical levels of toxicants in the body and whether this may ultimately impact outcomes for patients undergoing in vitro fertilization.

研究概览

研究类型

介入性

注册 (估计的)

60

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

描述

Inclusion criteria:

- Unexplained infertility diagnosis (no identifiable male or female causes to infertility)

Exclusion criteria:

  • Female age 38 years and older
  • Male age 45 and older
  • Diagnosis of diminished ovarian reserve
  • Diagnosis of PCOS/PMOS
  • Smoking or drug use in either male and/or female partner
  • BMI >40 in either partner
  • Patients using donor oocytes/donor sperm/donor embryos

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:其他
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Plastic Detox
All participants recruited
All patients will be provided education on environmental pollutants and provide practical steps to reduce exposure.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Concentration of Bisphenol in urine
大体时间:12 weeks
Concentration of bisphenol will be measured in urine for each participant at 0, 6, and 12 weeks.
12 weeks
Concentration of PFAS in blood
大体时间:12 weeks
Concentration of PFAS will be measured in blood for each participant at 0, 6, and 12 weeks.
12 weeks

次要结果测量

结果测量
措施说明
大体时间
Baseline environmental exposure questionnaire
大体时间:1 week
Participants will provide information to quantify their environmental exposures prior to the intervention in the form of a questionnaire. Questions have been adapted from PACeQ (plastic associated chemicals exposure questionnaire) to assess exposure to diet/food preparation practices, physical environment, and personal care products. The questionnaire will be delivered electronically.
1 week
Participant perception of educational material questionnaire
大体时间:1 week
Participants will assess the effectiveness of the educational material provided in the intervention. Questionnaire adapted from the Patient Education Materials Assessment Tool (PEMAT).
1 week
Weekly Questionnaire to measure compliance with implementation strategies
大体时间:12 weeks
Participants in this study will choose implementation strategies to decrease their environmental exposure based on options provided in the education. The participants will then provide a weekly summary of their compliance with their chosen implementation strategies in the form of a questionnaire administered electronically.
12 weeks
Concentration of bisphenol in follicular fluid and seminal fluid
大体时间:12 weeks
Participants follicular fluid and seminal fluid bisphenol concentration will be compared to a sample of previously banked control specimens.
12 weeks
Concentration of PFAS in follicular fluid and seminal fluid
大体时间:12 weeks
Participants follicular fluid and seminal fluid PFAS concentration will be compared to a sample of previously banked control specimens.
12 weeks
Seminal fluid analysis
大体时间:12 weeks
Semen sample will be analyzed prior to participants undergoing education on environmental toxins and methods to decrease exposure. This baseline semen sample will then be compared to semen samples following the 12 week environmental pollutant detox. Seminal fluid components that will be compared include concentration, motility, morphology, total motile sperm count.
12 weeks
IVF Outcomes
大体时间:45 weeks
Compare oocyte yield, fertilization rate, blastulation rate, clinical pregnancy rate, live birth rate to matched patients that did not undergo environmental pollutant detox.
45 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月1日

初级完成 (估计的)

2027年6月30日

研究完成 (估计的)

2028年2月28日

研究注册日期

首次提交

2026年8月20日

首先提交符合 QC 标准的

2026年8月31日

首次发布 (实际的)

2026年9月3日

研究记录更新

最后更新发布 (实际的)

2026年9月3日

上次提交的符合 QC 标准的更新

2026年8月31日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 202606064
  • Environmental Fellows Award (其他赠款/资助编号:American Society for Reproductive Medicine)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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