NCT07802691

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
17mo left

Started Oct 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Oct 2026Feb 2028

First Submitted

Initial submission to the registry

August 20, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 3, 2026

Completed
28 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2028

Last Updated

September 3, 2026

Status Verified

August 1, 2026

Enrollment Period

9 months

First QC Date

August 20, 2026

Last Update Submit

August 31, 2026

Conditions

Infertility (IVF Patients)

Outcome Measures

Primary Outcomes (2)

  • Concentration of Bisphenol in urine

    Concentration of bisphenol will be measured in urine for each participant at 0, 6, and 12 weeks.

    12 weeks

  • Concentration of PFAS in blood

    Concentration of PFAS will be measured in blood for each participant at 0, 6, and 12 weeks.

    12 weeks

Secondary Outcomes (7)

  • Baseline environmental exposure questionnaire

    1 week

  • Participant perception of educational material questionnaire

    1 week

  • Weekly Questionnaire to measure compliance with implementation strategies

    12 weeks

  • Concentration of bisphenol in follicular fluid and seminal fluid

    12 weeks

  • Concentration of PFAS in follicular fluid and seminal fluid

    12 weeks

  • +2 more secondary outcomes

Study Arms (1)

Plastic Detox

EXPERIMENTAL

All participants recruited

Behavioral: Environmental Pollutant Detox

Interventions

Environmental Pollutant DetoxBEHAVIORAL

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

Plastic Detox

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Central Study Contacts

Abigail Mancuso, MD

CONTACT

319-356-1767abigail-mancuso@uiowa.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

August 20, 2026

First Posted

September 3, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

February 28, 2028

Last Updated

September 3, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share