Plastic Detox During IVF Treatment

August 31, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Plastic Detox
All participants recruited
Behavioral: Environmental Pollutant Detox
All patients will be provided education on environmental pollutants and provide practical steps to reduce exposure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration of Bisphenol in urine
Time Frame: 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
Time Frame: 12 weeks
Concentration of PFAS will be measured in blood for each participant at 0, 6, and 12 weeks.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baseline environmental exposure questionnaire
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abigail Mancuso

Collaborators

American Society for Reproductive Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

February 28, 2028

Study Registration Dates

First Submitted

August 20, 2026

First Submitted That Met QC Criteria

August 31, 2026

First Posted (Actual)

September 3, 2026

Study Record Updates

Last Update Posted (Actual)

September 3, 2026

Last Update Submitted That Met QC Criteria

August 31, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202606064
  • Environmental Fellows Award (Other Grant/Funding Number: American Society for Reproductive Medicine)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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