InfertilityNCT07641387
A Large-scale, Prospective Cohort Study Was Conducted to Explore the Association Between Environmental Exposure and Behavioral Factors and Infertility (the Success Rate of Assisted Reproductive Technology)
A study testing Life Style Intervention and Environmental exposure in people with Infertility and Infertility Assisted Reproductive Technology, run by The Third Xiangya Hospital of Central South University at 1 site in China.
Trial summary
The aim is to explore the reasons for the failure of assisted reproductive technology (ART) in infertile patients in Hunan Province and seek ways to improve the success rate of ART. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Infertility, Infertility Assisted Reproductive Technology, Infertility (IVF Patients)
- What is being tested?
- Life Style Intervention and Environmental exposure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2025to 1 Apr 2035
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1. Women aged 18 to 46 who use their own eggs or men aged 18 to 55 who use their own sperm; 2. Patients who meet the diagnostic criteria for infertility; 3. Clarify the medical history of persistent infertility for a certain period of time; 4. Voluntarily participate in the project and sign the informed consent form.
Who cannot join
- 1. Artificial insemination population with any of the following ARTs contraindications: a. Impairment of sperm and egg combination caused by fallopian tube factors on the female side. b. The female side suffers from acute infection of the reproductive and urinary system or sexually transmitted diseases. c. The female side suffers from genetic diseases, serious physical diseases, and mental and psychological disorders. d. There is a history of birth of babies with congenital defects and it is confirmed that it is caused by female factors. e. The female side is exposed to teratogenic radiation, poisons, and drugs and is in the period of action. f. The female side has bad habits such as alcoholism and drug abuse.
- 2. First-generation test-tube baby and second-generation test-tube baby population with any of the following ARTs contraindications: a. Any party who provides gametes suffers from acute infection of the reproductive and urinary systems and sexually transmitted diseases or has bad habits such as alcoholism and drug abuse. b. Any party who provides gametes is exposed to teratogenic radiation, poisons, and drugs and is in the period of action. c. The couple who received embryo donation/egg donation suffers from acute infection of reproductive and urinary system and sexually transmitted diseases, or has bad habits such as alcoholism and drug abuse. d. The woman's uterus is not capable of pregnancy or has a serious physical disease that cannot withstand pregnancy.
- 3. No embryo transfer after egg retrieval; 4. Frozen embryo transfer is received more than 180 days after egg retrieval.
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
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013
Xingping Zhao, +86 13327215012
About this study
The aim is to explore the reasons for the failure of assisted reproductive technology (ART) in infertile patients in Hunan Province and seek ways to improve the success rate of ART. The study will focus on how environmental exposure (such as environmental pollutants related to plastic products) and lifestyle and social factors affect the success rate of ART in infertile patients.
In order to explore these issues in depth, the study plans to collect 5,000 samples (male: female ratio 1:1), screen the research subjects from infertile patients who visited Xiangya Third Hospital in Changsha, Hunan Province, and establish a large-scale, prospective infertility patient cohort. By collecting multi-faceted information of the research subjects, including sociodemographic characteristics, lifestyle, basic health status, etc., and conducting long-term follow-up observations, the ART live birth situation of infertile patients is analyzed.
Read more
In terms of research methods, a multivariate analysis method will be used to explore the association between various factors and ART success rate, and a risk prediction model will be constructed. In addition, the study also hopes to clarify the specific reasons for the failure of infertile patients to receive ART, provide a scientific basis for clinical decision-making, and provide guidance for the formulation of environmental protection policies and the improvement of public reproductive health literacy.
In general, this study, through a large-scale, prospective cohort study, deeply explores the various factors that affect the success rate of ART in infertile patients, and strives to build a risk prediction model in order to improve the success rate of ART and bring more hope to infertile families.
Read the detailed description
Purpose of the study: This study aims to clarify the reasons for the failure of assisted reproductive technology (ART) in infertile patients in Hunan Province, to achieve early identification and prediction of risk factors, and thus improve the success rate of ART.
Experimental design:
Prospective cohort study, 5,000 people are planned to be collected (male-female ratio 1:1).
Experimental process:
- Establish a large-scale, prospective infertility patient cohort to provide basic data for studying the relationship between environmental factors, biological factors and social factors and ART success rate.
- Analyze the relationship between exposure (internal exposure) to environmental factors (such as environmental pollutants related to plastic products) and infertility (ART success rate), and provide a scientific basis for the formulation of environmental protection policies.
- Explore the impact of lifestyle and social factors on the ART success rate of infertile patients, and provide guidance for improving the public's reproductive health literacy.
- Construct a prediction model for adverse pregnancy outcomes of infertility ART, and provide new ideas for improving the ART success rate of infertile patients.
Inclusion criteria:
(1) A. Women aged 18 to 46 years old using their own eggs or men aged 18 to 55 years old using their own sperm; B. Patients who meet the diagnostic criteria for infertility; C. A clear history of persistent infertility; D. Voluntary participation in the project and signing of the informed consent form;
Exclusion criteria:
(1) A. People with any of the following contraindications to ARTs: a. Impairment of sperm and egg combination caused by fallopian tube factors in the female. b. Acute infection of the reproductive and urinary system or sexually transmitted diseases in the female. c. Genetic diseases, serious physical diseases, and mental and psychological disorders in the female. d. History of birth of babies with congenital defects confirmed to be caused by the female. e. The female is exposed to teratogenic radiation, poisons, and drugs and is in the period of action. f. The female has bad habits such as alcoholism and drug abuse. B. People who have any of the following contraindications to ARTs for first-generation and second-generation test-tube babies: a. Any party who provides gametes suffers from acute infection of the reproductive and urinary systems and sexually transmitted diseases, or has bad habits such as alcoholism and drug abuse. b. Any party who provides gametes is exposed to teratogenic radiation, poisons, and drugs and is in the period of action. c. The couple who receive embryo donation/egg donation suffers from acute infection of the reproductive and urinary systems and sexually transmitted diseases, or has bad habits such as alcoholism and drug abuse. d. The woman's uterus does not have the function of pregnancy or has a serious physical disease that cannot withstand pregnancy. C. No embryo transfer is performed after egg retrieval; D. Frozen embryo transfer is received more than 180 days after egg retrieval;
- Being tested
- Life Style Intervention, Environmental exposure
- Keywords
- environmental pollutants, Assisted Reproductive Technology, prospective cohort, life-style, risk factor, social factor
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Life Style InterventionBehavioural
- Diet and nutrition: Food frequency questionnaire + whether there is a habit of packing food in plastic bags + usage of disposable tableware, etc.
- Daily routine: Physical exercise (frequency, duration); Daily time spent using electronic products Sleep quality (start and end time), nap habits (duration of short naps); c. Working environment: Whether there are conditions unfavorable for fertility, such as being unable to sit still frequently, high temperatures, environmental pollution, radiation, chemical reagents, etc.
- Living environment: Exposure to chemicals, pesticides, radiation or toxins such as lead, especially frequent exposure; Exposure to kitchen fumes Have you been living in a house with new furniture or new decoration recently? Whether there are garbage stations or transportation hubs nearby; e. Personal care: Use of skin care products, cosmetics, etc. (frequency, types of products used); Annual frequency of perming, dyeing and manicure.
Environmental exposureBiological
Also called Lifestyle, Behavioral patterns
Environmental factors include:
- Traditional air pollutants: Data of six traditional air pollutants (PM2.5, PM10, SO2, CO, NO2 and O3);
- Environmental pollutants related to plastic products;
- Whether there are any decoration conditions in the living environment or whether there are any environmental influencing factors such as petrochemical plants or waste incineration stations around
Lifestyle behavior patterns include:
- Dietary nutrition: Food frequency questionnaire + whether there is a habit of packing food in plastic bags + usage of disposable tableware, etc.
- Daily routine: Physical exercise (frequency, duration), etc.
- Working environment: Whether there are frequent sitting, high temperatures, environmental pollution, radiation, chemical reagents, etc.
- Living environment: Exposure to toxins, etc.
- Personal care: Frequency of using cosmetics, etc.
| Study group | Role | What they receive |
|---|---|---|
| Environmental exposure and behavioral factors | Experimental | Environmental factors include: traditional air pollutants, plastic products, decoration conditions, and the vicinity of petrochemical plants or waste incineration stations Behavioral factors include: diet and nutrition, daily routine, working environment, living environment, and personal care. Receives: Behavioral: Life Style Intervention; Biological: Environmental exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Live Birth Following Assisted Reproductive Technology (ART) Treatment
Live birth is defined as the delivery of any viable infant (≥24 weeks of gestation) resulting from ART treatment.
Measured: From embryo transfer to delivery (up to 42 weeks post-transfer)
Number of Participants with ART Treatment Failure (Composite Outcome)
ART failure is defined as failure to achieve a live birth, including: no pregnancy, biochemical pregnancy loss, clinical miscarriage (pregnancy loss before 20 weeks), stillbirth (fetal death at ≥20 weeks), or neonatal death within 28 days of birth.
Measured: From the start of ART treatment to 42 weeks after embryo transfer
Secondary outcomes (5)
Number of Participants with Clinical Pregnancy Following ART Treatment
Clinical pregnancy is defined as the presence of at least one intrauterine gestational sac confirmed by transvaginal ultrasound.
Measured: At 4-6 weeks after embryo transfer
Number of Participants with Miscarriage Following ART Treatment
Miscarriage (spontaneous abortion) is defined as pregnancy loss before 20 completed weeks of gestation.
Measured: From confirmation of clinical pregnancy to before 20 weeks of gestation
Number of Participants with Preterm Birth Following ART Treatment
Preterm birth is defined as delivery before 37 completed weeks of gestation.
Measured: At delivery
Number of Participants with Low Birth Weight Infant Following ART Treatment
Low birth weight is defined as birth weight <2500 g.
Measured: At delivery
Number of Participants with Congenital Anomalies in Newborns Following ART Treatment
Congenital anomalies include major structural or functional disorders present at birth, diagnosed prenatally or within 28 days after birth.
Measured: From birth up to 28 days postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start1 Apr 2025
- Primary completion1 Apr 2030 (estimated)
- Study completion1 Apr 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Third Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07641387
- Sponsor's protocol ID
- xy3-SHE-Peng
- Status last verified
- Jun 2026
- First submitted
- 15 May 2025
- Last updated
- 11 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Large-scale, Prospective Cohort Study Was Conducted to Explore the Association Between Environmental Exposure and Behavioral Factors and Infertility (the Success Rate of Assisted Reproductive Technology)
- ClinicalTrials.gov ID
- NCT07641387
- Acronym / sponsor ID
- xy3-SHE-Peng
- Keywords
- environmental pollutants, Assisted Reproductive Technology, prospective cohort, life-style, risk factor, social factor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- The Third Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Apr 2030 (estimated)
- Study completion
- 1 Apr 2035 (estimated)
- First posted
- 11 Jun 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.
The aim is to explore the reasons for the failure of assisted reproductive technology (ART) in infertile patients in Hunan Province and seek ways to improve the success rate of ART. The study will focus on how environmental exposure (such as environmental pollutants related to plastic products) and lifestyle and social factors affect the success rate of ART in infertile patients.
In order to explore these issues in depth, the study plans to collect 5,000 samples (male: female ratio 1:1), screen the research subjects from infertile patients who visited Xiangya Third Hospital in Changsha, Hunan Province, and establish a large-scale, prospective infertility patient cohort. By collecting multi-faceted information of the research subjects, including sociodemographic characteristics, lifestyle, basic health status, etc., and conducting long-term follow-up observations, the ART live birth situation of infertile patients is analyzed.
In terms of research methods, a multivariate analysis method will be used to explore the association between various factors and ART success rate, and a risk prediction model will be constructed. In addition, the study also hopes to clarify the specific reasons for the failure of infertile patients to receive ART, provide a scientific basis for clinical decision-making, and provide guidance for the formulation of environmental protection policies and the improvement of public reproductive health literacy.
In general, this study, through a large-scale, prospective cohort study, deeply explores the various factors that affect the success rate of ART in infertile patients, and strives to build a risk prediction model in order to improve the success rate of ART and bring more hope to infertile families.
Detailed description
Purpose of the study: This study aims to clarify the reasons for the failure of assisted reproductive technology (ART) in infertile patients in Hunan Province, to achieve early identification and prediction of risk factors, and thus improve the success rate of ART.
Experimental design:
Prospective cohort study, 5,000 people are planned to be collected (male-female ratio 1:1).
Experimental process:
- Establish a large-scale, prospective infertility patient cohort to provide basic data for studying the relationship between environmental factors, biological factors and social factors and ART success rate.
- Analyze the relationship between exposure (internal exposure) to environmental factors (such as environmental pollutants related to plastic products) and infertility (ART success rate), and provide a scientific basis for the formulation of environmental protection policies.
- Explore the impact of lifestyle and social factors on the ART success rate of infertile patients, and provide guidance for improving the public's reproductive health literacy.
- Construct a prediction model for adverse pregnancy outcomes of infertility ART, and provide new ideas for improving the ART success rate of infertile patients.
Inclusion criteria:
(1) A. Women aged 18 to 46 years old using their own eggs or men aged 18 to 55 years old using their own sperm; B. Patients who meet the diagnostic criteria for infertility; C. A clear history of persistent infertility; D. Voluntary participation in the project and signing of the informed consent form;
Exclusion criteria:
(1) A. People with any of the following contraindications to ARTs: a. Impairment of sperm and egg combination caused by fallopian tube factors in the female. b. Acute infection of the reproductive and urinary system or sexually transmitted diseases in the female. c. Genetic diseases, serious physical diseases, and mental and psychological disorders in the female. d. History of birth of babies with congenital defects confirmed to be caused by the female. e. The female is exposed to teratogenic radiation, poisons, and drugs and is in the period of action. f. The female has bad habits such as alcoholism and drug abuse. B. People who have any of the following contraindications to ARTs for first-generation and second-generation test-tube babies: a. Any party who provides gametes suffers from acute infection of the reproductive and urinary systems and sexually transmitted diseases, or has bad habits such as alcoholism and drug abuse. b. Any party who provides gametes is exposed to teratogenic radiation, poisons, and drugs and is in the period of action. c. The couple who receive embryo donation/egg donation suffers from acute infection of the reproductive and urinary systems and sexually transmitted diseases, or has bad habits such as alcoholism and drug abuse. d. The woman's uterus does not have the function of pregnancy or has a serious physical disease that cannot withstand pregnancy. C. No embryo transfer is performed after egg retrieval; D. Frozen embryo transfer is received more than 180 days after egg retrieval;
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Environmental exposure and behavioral factors | Experimental | Behavioral: Life Style Intervention, Biological: Environmental exposureEnvironmental factors include: traditional air pollutants, plastic products, decoration conditions, and the vicinity of petrochemical plants or waste incineration stations Behavioral factors include: diet and nutrition, daily routine, working environment, living environment, and personal care. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. Women aged 18 to 46 who use their own eggs or men aged 18 to 55 who use their own sperm; 2. Patients who meet the diagnostic criteria for infertility; 3. Clarify the medical history of persistent infertility for a certain period of time; 4. Voluntarily participate in the project and sign the informed consent form.
Key exclusion criteria (3 listed)
- 1. Artificial insemination population with any of the following ARTs contraindications: a. Impairment of sperm and egg combination caused by fallopian tube factors on the female side. b. The female side suffers from acute infection of the reproductive and urinary system or sexually transmitted diseases. c. The female side suffers from genetic diseases, serious physical diseases, and mental and psychological disorders. d. There is a history of birth of babies with congenital defects and it is confirmed that it is caused by female factors. e. The female side is exposed to teratogenic radiation, poisons, and drugs and is in the period of action. f. The female side has bad habits such as alcoholism and drug abuse.
- 2. First-generation test-tube baby and second-generation test-tube baby population with any of the following ARTs contraindications: a. Any party who provides gametes suffers from acute infection of the reproductive and urinary systems and sexually transmitted diseases or has bad habits such as alcoholism and drug abuse. b. Any party who provides gametes is exposed to teratogenic radiation, poisons, and drugs and is in the period of action. c. The couple who received embryo donation/egg donation suffers from acute infection of reproductive and urinary system and sexually transmitted diseases, or has bad habits such as alcoholism and drug abuse. d. The woman's uterus is not capable of pregnancy or has a serious physical disease that cannot withstand pregnancy.
- 3. No embryo transfer after egg retrieval; 4. Frozen embryo transfer is received more than 180 days after egg retrieval.
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 |
|---|---|---|
| Life Style InterventionA. Diet and nutrition: Food frequency questionnaire + whether there is a habit of packing food in plastic bags + usage of disposable tableware, etc. b. Daily routine: Physical exercise (frequency, duration); Daily time spent using electronic products Sleep quality (start and end time), nap habits (duration of short naps); c. Working environment: Whether there are conditions unfavorable for fertility, such as being unable to sit still frequently, high temperatures, environmental pollution, radiation, chemical reagents, etc. d. Living environment: Exposure to chemicals, pesticides, radiation or toxins such as lead, especially frequent exposure; Exposure to kitchen fumes Have you been living in a house with new furniture or new decoration recently? Whether there are garbage stations or transportation hubs nearby; e. Personal care: Use of skin care products, cosmetics, etc. (frequency, types of products used); Annual frequency of perming, dyeing and manicure. | Behavioural | Environmental exposure and behavioral factors |
| Environmental exposureAlso: Lifestyle, Behavioral patternsEnvironmental factors include: 1. Traditional air pollutants: Data of six traditional air pollutants (PM2.5, PM10, SO2, CO, NO2 and O3); 2. Environmental pollutants related to plastic products; 3. Whether there are any decoration conditions in the living environment or whether there are any environmental influencing factors such as petrochemical plants or waste incineration stations around Lifestyle behavior patterns include: 1. Dietary nutrition: Food frequency questionnaire + whether there is a habit of packing food in plastic bags + usage of disposable tableware, etc. 2. Daily routine: Physical exercise (frequency, duration), etc. 3. Working environment: Whether there are frequent sitting, high temperatures, environmental pollution, radiation, chemical reagents, etc. 4. Living environment: Exposure to toxins, etc. 5. Personal care: Frequency of using cosmetics, etc. | Biological | Environmental exposure and behavioral factors |
Primary outcome
Number of Participants with Live Birth Following Assisted Reproductive Technology (ART) Treatment
Time frame: From embryo transfer to delivery (up to 42 weeks post-transfer)
Live birth is defined as the delivery of any viable infant (≥24 weeks of gestation) resulting from ART treatment.
Number of Participants with ART Treatment Failure (Composite Outcome)
Time frame: From the start of ART treatment to 42 weeks after embryo transfer
ART failure is defined as failure to achieve a live birth, including: no pregnancy, biochemical pregnancy loss, clinical miscarriage (pregnancy loss before 20 weeks), stillbirth (fetal death at ≥20 weeks), or neonatal death within 28 days of birth.
5 secondary outcomes
Number of Participants with Clinical Pregnancy Following ART Treatment
Time frame: At 4-6 weeks after embryo transfer
Number of Participants with Miscarriage Following ART Treatment
Time frame: From confirmation of clinical pregnancy to before 20 weeks of gestation
Number of Participants with Preterm Birth Following ART Treatment
Time frame: At delivery
Number of Participants with Low Birth Weight Infant Following ART Treatment
Time frame: At delivery
Number of Participants with Congenital Anomalies in Newborns Following ART Treatment
Time frame: From birth up to 28 days postpartum
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 11 Jun 2026.
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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?
A study testing Life Style Intervention and Environmental exposure in people with Infertility and Infertility 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 3 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 11 Jun 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 (+86 13327215012, zxp8846@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Live Birth Following Assisted Reproductive Technology (ART) Treatment (time frame: From embryo transfer to delivery (up to 42 weeks post-transfer)). 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 11 Jun 2026.