Infertility (IVF Patients)NCT07802691
Plastic Detox During IVF Treatment
A study testing Environmental Pollutant Detox in people with Infertility (IVF Patients), run by Abigail Mancuso.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Infertility (IVF Patients)
- What is being tested?
- Environmental Pollutant Detox
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 28 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Unexplained infertility diagnosis (no identifiable male or female causes to infertility)
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Infertility (IVF Patients)
- Being tested
- Environmental Pollutant Detox
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Environmental Pollutant DetoxBehavioural
All patients will be provided education on environmental pollutants and provide practical steps to reduce exposure.
| Study group | Role | What they receive |
|---|---|---|
| Plastic Detox | Experimental | All participants recruited Receives: Behavioral: Environmental Pollutant Detox |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of Bisphenol in urine
Concentration of bisphenol will be measured in urine for each participant at 0, 6, and 12 weeks.
Measured: 12 weeks
Concentration of PFAS in blood
Concentration of PFAS will be measured in blood for each participant at 0, 6, and 12 weeks.
Measured: 12 weeks
Secondary outcomes (7)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 45 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility (IVF Patients)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abigail Mancuso
- Sponsor type
- University, hospital or other
- Collaborators
- American Society for Reproductive Medicine
- Responsible party
- Sponsor-investigator, Abigail Mancuso, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07802691
- Sponsor's protocol ID
- 202606064
- Other IDs
- Environmental Fellows Award
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endocrine Disrupting Chemical Detox: a Practical Method to Decrease Environmental Exposures and an Evaluation of the Impact on in Vitro Fertilization Treatment
- ClinicalTrials.gov ID
- NCT07802691
- Acronym / sponsor ID
- 202606064
- Conditions
- Infertility (IVF Patients)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Abigail MancusoUniversity, hospital or other
- Collaborators
- American Society for Reproductive Medicine
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Plastic Detox | Experimental | Behavioral: Environmental Pollutant DetoxAll participants recruited |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Unexplained infertility diagnosis (no identifiable male or female causes to infertility)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Environmental Pollutant DetoxAll patients will be provided education on environmental pollutants and provide practical steps to reduce exposure. | Behavioural | Plastic Detox |
Primary outcome
Concentration of Bisphenol in urine
Time frame: 12 weeks
Concentration of bisphenol will be measured in urine for each participant at 0, 6, and 12 weeks.
Concentration of PFAS in blood
Time frame: 12 weeks
Concentration of PFAS will be measured in blood for each participant at 0, 6, and 12 weeks.
7 secondary outcomes
Baseline environmental exposure questionnaire
Time frame: 1 week
Participant perception of educational material questionnaire
Time frame: 1 week
Weekly Questionnaire to measure compliance with implementation strategies
Time frame: 12 weeks
Concentration of bisphenol in follicular fluid and seminal fluid
Time frame: 12 weeks
Concentration of PFAS in follicular fluid and seminal fluid
Time frame: 12 weeks
Seminal fluid analysis
Time frame: 12 weeks
IVF Outcomes
Time frame: 45 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Environmental Pollutant Detox in people with Infertility (IVF Patients), run by Abigail Mancuso.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abigail Mancuso, MD (319-356-1767, abigail-mancuso@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of Bisphenol in urine (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.