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)

June 8, 2026 updated by: The Third Xiangya Hospital of Central South University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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:

  1. 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.
  2. 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.
  3. 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.
  4. 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 Type

Interventional

Enrollment (Estimated)

5000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410013
        • Recruiting
        • The Third Xiangya Hospital of Central South University
        • Contact:
          • Xingping Zhao
          • Phone Number: +86 13327215012

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Environmental exposure and behavioral factors
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.
Behavioral: Life Style Intervention

A. 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.

Biological: Environmental exposure

Environmental 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.
Other Names:
  • Lifestyle
  • Behavioral patterns

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From embryo transfer to delivery (up to 42 weeks post-transfer)
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.
From the start of ART treatment to 42 weeks after embryo transfer

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Clinical Pregnancy Following ART Treatment
Time Frame: At 4-6 weeks after embryo transfer
Clinical pregnancy is defined as the presence of at least one intrauterine gestational sac confirmed by transvaginal ultrasound.
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
Miscarriage (spontaneous abortion) is defined as pregnancy loss before 20 completed weeks of gestation.
From confirmation of clinical pregnancy to before 20 weeks of gestation
Number of Participants with Preterm Birth Following ART Treatment
Time Frame: At delivery
Preterm birth is defined as delivery before 37 completed weeks of gestation.
At delivery
Number of Participants with Low Birth Weight Infant Following ART Treatment
Time Frame: At delivery
Low birth weight is defined as birth weight <2500 g.
At delivery
Number of Participants with Congenital Anomalies in Newborns Following ART Treatment
Time Frame: From birth up to 28 days postpartum
Congenital anomalies include major structural or functional disorders present at birth, diagnosed prenatally or within 28 days after birth.
From birth up to 28 days postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Third Xiangya Hospital of Central South University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2025

Primary Completion (Estimated)

April 1, 2030

Study Completion (Estimated)

April 1, 2035

Study Registration Dates

First Submitted

May 15, 2025

First Submitted That Met QC Criteria

June 8, 2026

First Posted (Actual)

June 11, 2026

Study Record Updates

Last Update Posted (Actual)

June 11, 2026

Last Update Submitted That Met QC Criteria

June 8, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • xy3-SHE-Peng

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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