An interventional study of Environmental Pollutant Detox in Infertility (IVF Patients), sponsored by Abigail Mancuso. Recruiting at 1 site in United States. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Abigail Mancuso · Not applicable, Interventional, and Other
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.
2,085 studies on the registry are indexed under Infertility; 357 are open to participants now.
This study's planned enrollment of 60 is below the median of 135 across 1,412 interventional studies indexed under Infertility.
Browse Infertility studies →This is the only study on the registry with Abigail Mancuso as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
- Unexplained infertility diagnosis (no identifiable male or female causes to infertility)
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants recruited
Behavioral: Environmental Pollutant Detox
All patients will be provided education on environmental pollutants and provide practical steps to reduce exposure.
Concentration of Bisphenol in urine
Concentration of bisphenol will be measured in urine for each participant at 0, 6, and 12 weeks.
Time frame: 12 weeks
Concentration of PFAS in blood
Concentration of PFAS will be measured in blood for each participant at 0, 6, and 12 weeks.
Time frame: 12 weeks
Baseline environmental exposure questionnaire
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.
Time frame: 1 week
Participant perception of educational material questionnaire
Participants will assess the effectiveness of the educational material provided in the intervention. Questionnaire adapted from the Patient Education Materials Assessment Tool (PEMAT).
Time frame: 1 week
Weekly Questionnaire to measure compliance with implementation strategies
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.
Time frame: 12 weeks
Concentration of bisphenol in follicular fluid and seminal fluid
Participants follicular fluid and seminal fluid bisphenol concentration will be compared to a sample of previously banked control specimens.
Time frame: 12 weeks
Concentration of PFAS in follicular fluid and seminal fluid
Participants follicular fluid and seminal fluid PFAS concentration will be compared to a sample of previously banked control specimens.
Time frame: 12 weeks
Seminal fluid analysis
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.
Time frame: 12 weeks
IVF Outcomes
Compare oocyte yield, fertilization rate, blastulation rate, clinical pregnancy rate, live birth rate to matched patients that did not undergo environmental pollutant detox.
Time frame: 45 weeks
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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