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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Abigail Mancuso, MD
- Telefonnummer: 319-356-1767
- E-Mail: abigail-mancuso@uiowa.edu
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Plastic Detox
All participants recruited
|
All patients will be provided education on environmental pollutants and provide practical steps to reduce exposure.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Concentration of Bisphenol in urine
Zeitfenster: 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
Zeitfenster: 12 weeks
|
Concentration of PFAS will be measured in blood for each participant at 0, 6, and 12 weeks.
|
12 weeks
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Baseline environmental exposure questionnaire
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 202606064
- Environmental Fellows Award (Andere Zuschuss-/Finanzierungsnummer: American Society for Reproductive Medicine)
Plan für individuelle Teilnehmerdaten (IPD)
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Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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