Environmental ExposureNCT07384676
Environmental and Behavioral Factors in Infertility and ART Outcomes
An observational study of Environmental Exposure and Assisted Reproductive Technology, run by The Third Xiangya Hospital of Central South University at 1 site in China.
Trial summary
This large-scale study aims to understand how everyday environment and lifestyle may affect the success of fertility treatments like IVF. The main idea is that exposure to certain environmental chemicals (e.g., from plastics or air pollution) and personal habits (e.g., diet, stress) could be linked to whether these… Read more about this study
- Who is it for?
- Ages 18 to 46 yearsHealthy volunteers can take part
- Conditions the study is for
- Environmental Exposure, Assisted Reproductive Technology, Prospective Study
- What is being tested?
- plastic products and None exposure
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 31 Dec 2034
- How long will I take part?
- 18 Months
- Phase
- Observational
- 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 46 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: This study aims to establish a cohort of infertility patients in Hunan Province. Patients with infertility who visited Xiangya Third Hospital in Changsha, Hunan Province from December 2024 to December 2034 will be included. The research subjects will be selected based on clear inclusion and exclusion criteria. Baseline data covering social demographic characteristics, lifestyle behaviors, basic health status, physiological and biochemical indicators, and exposure measurements of environmental factors will be collected from the start of the study to follow-up until the time of childbirth, pregnancy, delivery, and postpartum care, to observe the live birth situation of infertility patients through ART. This will provide data support for the research on identifying risk factors, early prediction, intervention and prevention of infertility patients' ART.
Who may be able to join
- A. Women aged 18 to 46 who use their own eggs; Men aged 18 to 55 who use their own sperm; B. Patients meeting the diagnostic criteria for infertility; C. Medical history clearly indicating the duration of persistent infertility; D. Voluntarily participating in the project and signing the informed consent form;
Who cannot join
- A. The groups of artificial insemination patients with any of the following ARTs contraindications: a. The female has a sperm-egg combination disorder caused by tubal factors. b. The female has acute infections of the reproductive and urinary systems or sexually transmitted diseases. c. The female has genetic diseases, severe physical illnesses, or mental and psychological disorders. d. There is a history of giving birth to infants with congenital defects and it has been confirmed that the defect was caused by the female. e. The female has been exposed to teratogenic doses of radiation, toxins, or drugs and is in the active period. f. The female has bad habits such as alcoholism or drug abuse. B. The groups of first-generation and second-generation IVF patients with any of the following ARTs contraindications: a. Either of the parties providing gametes has acute infections of the reproductive and urinary systems and sexually transmitted diseases or has bad habits such as alcoholism or drug abuse. b. Either of the parties providing gametes has been exposed to teratogenic doses of radiation, toxins, or drugs and is in the active period. c. The female partner of the recipient who provides eggs or embryos has acute infections of the reproductive and urinary systems and sexually transmitted diseases, or has bad habits such as alcoholism or drug abuse. d. The female has an unviable uterus or severe physical illnesses that cannot withstand pregnancy. C. No embryo transfer was performed after egg retrieval; D. More than 180 days have passed since egg retrieval and frozen embryo transfer was performed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Reproductive Medicine Center of Xiangya Third Hospital of Central South University
Changsha, Hunan, 410013
Xingping Zhao, 13327215012, pengena@163.com
About this study
Official title: A Large-Scale Prospective Cohort Study on the Association of Environmental Exposures and Behavioral Factors With Infertility and Assisted Reproductive Technology (ART) Success Rates
This large-scale study aims to understand how everyday environment and lifestyle may affect the success of fertility treatments like IVF. The main idea is that exposure to certain environmental chemicals (e.g., from plastics or air pollution) and personal habits (e.g., diet, stress) could be linked to whether these treatments result in a successful pregnancy and live birth.
The study will follow approximately 5,000 couples undergoing fertility treatment in Hunan, China. Participants will answer questionnaires about their health, lifestyle, and environment and provide small biological samples (like blood and urine) during their standard treatment process. Their treatment outcomes will be tracked anonymously.The goal is to identify factors that might lower the chances of treatment success. This knowledge could help future patients and doctors make informed decisions and could guide public health advice on reducing potential risks. The study has received ethical approval, and all participant information will be kept strictly confidential.
- Being tested
- plastic products, None exposure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plastic productsBehavioural
Environmental pollutants related to plastic products
None exposureBehavioural
No environmental pollutants related to plastic products
| Study group | Role | What they receive |
|---|---|---|
| Exposure group | Not described Receives: Behavioral: plastic products | |
| Non-exposure group | Not described Receives: Behavioral: None exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth rate following the first ART cycle
The proportion of participants achieving at least one live birth (gestational age ≥ 28 weeks) after the initiation of their first ART treatment cycle.
Measured: Within 24 months from the initiation of the first ART cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start1 Dec 2024
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Environmental ExposureStudies of the same condition, open and under way.
- More trials run by The Third Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 18 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peng enuo, The Third Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07384676
- Sponsor's protocol ID
- xy3-Peng-ENV
- Status last verified
- Jan 2026
- First submitted
- 26 Jan 2026
- Last updated
- 3 Feb 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 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Large-Scale Prospective Cohort Study on the Association of Environmental Exposures and Behavioral Factors With Infertility and Assisted Reproductive Technology (ART) Success Rates
- ClinicalTrials.gov ID
- NCT07384676
- Acronym / sponsor ID
- xy3-Peng-ENV
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- The Third Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2034 (estimated)
- First posted
- 3 Feb 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.
This large-scale study aims to understand how everyday environment and lifestyle may affect the success of fertility treatments like IVF. The main idea is that exposure to certain environmental chemicals (e.g., from plastics or air pollution) and personal habits (e.g., diet, stress) could be linked to whether these treatments result in a successful pregnancy and live birth.
The study will follow approximately 5,000 couples undergoing fertility treatment in Hunan, China. Participants will answer questionnaires about their health, lifestyle, and environment and provide small biological samples (like blood and urine) during their standard treatment process. Their treatment outcomes will be tracked anonymously.The goal is to identify factors that might lower the chances of treatment success. This knowledge could help future patients and doctors make informed decisions and could guide public health advice on reducing potential risks. The study has received ethical approval, and all participant information will be kept strictly confidential.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposure group | – | Behavioral: plastic products |
| Non-exposure group | – | Behavioral: None exposure |
Who may qualify
- Ages
- 18 to 46 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This study aims to establish a cohort of infertility patients in Hunan Province. Patients with infertility who visited Xiangya Third Hospital in Changsha, Hunan Province from December 2024 to December 2034 will be included. The research subjects will be selected based on clear inclusion and exclusion criteria. Baseline data covering social demographic characteristics, lifestyle behaviors, basic health status, physiological and biochemical indicators, and exposure measurements of environmental factors will be collected from the start of the study to follow-up until the time of childbirth, pregnancy, delivery, and postpartum care, to observe the live birth situation of infertility patients through ART. This will provide data support for the research on identifying risk factors, early prediction, intervention and prevention of infertility patients' ART.
Key inclusion criteria (1 listed)
- A. Women aged 18 to 46 who use their own eggs; Men aged 18 to 55 who use their own sperm; B. Patients meeting the diagnostic criteria for infertility; C. Medical history clearly indicating the duration of persistent infertility; D. Voluntarily participating in the project and signing the informed consent form;
Key exclusion criteria (1 listed)
- A. The groups of artificial insemination patients with any of the following ARTs contraindications: a. The female has a sperm-egg combination disorder caused by tubal factors. b. The female has acute infections of the reproductive and urinary systems or sexually transmitted diseases. c. The female has genetic diseases, severe physical illnesses, or mental and psychological disorders. d. There is a history of giving birth to infants with congenital defects and it has been confirmed that the defect was caused by the female. e. The female has been exposed to teratogenic doses of radiation, toxins, or drugs and is in the active period. f. The female has bad habits such as alcoholism or drug abuse. B. The groups of first-generation and second-generation IVF patients with any of the following ARTs contraindications: a. Either of the parties providing gametes has acute infections of the reproductive and urinary systems and sexually transmitted diseases or has bad habits such as alcoholism or drug abuse. b. Either of the parties providing gametes has been exposed to teratogenic doses of radiation, toxins, or drugs and is in the active period. c. The female partner of the recipient who provides eggs or embryos has acute infections of the reproductive and urinary systems and sexually transmitted diseases, or has bad habits such as alcoholism or drug abuse. d. The female has an unviable uterus or severe physical illnesses that cannot withstand pregnancy. C. No embryo transfer was performed after egg retrieval; D. More than 180 days have passed since egg retrieval and frozen embryo transfer was performed.
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 |
|---|---|---|
| plastic productsEnvironmental pollutants related to plastic products | Behavioural | Exposure group |
| None exposureNo environmental pollutants related to plastic products | Behavioural | Non-exposure group |
Primary outcome
Live birth rate following the first ART cycle
Time frame: Within 24 months from the initiation of the first ART cycle
The proportion of participants achieving at least one live birth (gestational age ≥ 28 weeks) after the initiation of their first ART treatment cycle.
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 Feb 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Environmental Exposure and Assisted Reproductive Technology, run by The Third Xiangya Hospital of Central South University at 1 site in China.
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 1 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: looking for participants now, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Xingping Zhao (13327215012, pengena@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live birth rate following the first ART cycle (time frame: Within 24 months from the initiation of the first ART cycle). 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 Feb 2026.