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NCT Number: NCT07802691

Plastic Detox During IVF 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.

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Key information

Conditions

Infertility (IVF Patients) Genital Diseases Infertility Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Environmental Pollutant Detox

Behavioral

All patients will be provided education on environmental pollutants and provide practical steps to reduce exposure.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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).

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Abigail Mancuso, MD

CONTACT

[email protected]

319-356-1767

Sponsors and collaborators

Lead sponsor

Abigail Mancuso

Other

Collaborators

  • American Society for Reproductive Medicine

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 3, 2026
Registry last updated
Sep 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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