Plastic Detox During IVF Treatment
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Abigail Mancuso, MD
- Telefoonnummer: 319-356-1767
- E-mail: abigail-mancuso@uiowa.edu
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Plastic Detox
All participants recruited
|
All patients will be provided education on environmental pollutants and provide practical steps to reduce exposure.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Concentration of Bisphenol in urine
Tijdsspanne: 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
Tijdsspanne: 12 weeks
|
Concentration of PFAS will be measured in blood for each participant at 0, 6, and 12 weeks.
|
12 weeks
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Baseline environmental exposure questionnaire
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 202606064
- Environmental Fellows Award (Ander subsidie-/financieringsnummer: American Society for Reproductive Medicine)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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