Health TrialsbyHealthPanel

Plastic Detox During IVF Treatment

ConditionInfertility (IVF Patients)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorAbigail Mancuso

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Female age 38 years and older

Male age 45 and older

Diagnosis of diminished ovarian reserve

Diagnosis of PCOS/PMOS

Trial design

Design model

Single group

Treatments tested in this trial

  • Environmental Pollutant Detox

    Behavioral

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

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Plastic DetoxExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Abigail Mancuso

Lead sponsor

University of Iowa

Sponsor institution

American Society for Reproductive Medicine

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: