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)

NCT07641387 | Recruiting

• 1 other identifier: xy3-SHE-Peng
• Study Type: interventional
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Infertility; Infertility Assisted Reproductive Technology; Infertility (IVF Patients)

Keywords

environmental pollutants; Assisted Reproductive Technology; prospective cohort; life-style; risk factor; social factor

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  From the start of ART treatment to 42 weeks after embryo transfer

Secondary Outcomes (5)

• Number of Participants with Clinical Pregnancy Following ART Treatment

  At 4-6 weeks after embryo transfer

• Number of Participants with Miscarriage Following ART Treatment

  From confirmation of clinical pregnancy to before 20 weeks of gestation

• Number of Participants with Preterm Birth Following ART Treatment

  At delivery

• Number of Participants with Low Birth Weight Infant Following ART Treatment

  At delivery

• Number of Participants with Congenital Anomalies in Newborns Following ART Treatment

  From birth up to 28 days postpartum

Study Arms (1)

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.

Behavioral: Life Style Intervention; Biological: Environmental exposure

Interventions

Life Style Intervention BEHAVIORAL

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.

Environmental exposure and behavioral factors

Environmental exposure BIOLOGICAL

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.

Also known as: Lifestyle, Behavioral patterns

Environmental exposure and behavioral factors

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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.
• \. 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.
• \. No embryo transfer after egg retrieval; 4. Frozen embryo transfer is received more than 180 days after egg retrieval.

Sponsors & Collaborators

• The Third Xiangya Hospital of Central South University: lead

Study Sites (1)

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

RECRUITING

MeSH Terms

Conditions

Infertility

Interventions

Environmental Exposure

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Environmental Pollution; Public Health; Environment and Public Health

Central Study Contacts

Xingping Zhao

CONTACT

+86 13327215012; zxp8846@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: June 11, 2026
• Study Start: April 1, 2025
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2035
• Last Updated: June 11, 2026

Record last verified: 2026-06

Locations

CN (1)