CClinicalTrials.gg
RecruitingNCT07384676Updated Feb 3, 2026

Environmental and Behavioral Factors in Infertility and ART Outcomes

An observational study in Environmental Exposure, Assisted Reproductive Technology and Prospective Study, sponsored by The Third Xiangya Hospital of Central South University. Recruiting at 1 site in China. Open to participants aged 18 Years to 46 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-03.

Sponsored by The Third Xiangya Hospital of Central South University · Observational

From the registry’s dates

  • Started Dec 2024; still recruiting 1 year 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5,000
Ages
18 Years to 46 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Environmental Exposure
  • Assisted Reproductive Technology
  • Prospective Study
03

In context

Lead sponsor

The Third Xiangya Hospital of Central South University is the lead sponsor of 95 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 46 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Inclusion criteria

  • 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;

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5,000 participants (estimated)
Target follow-up
18 Months
Patient registry
Yes

Groups and cohorts

  • Exposure group

    Behavioral: plastic products

  • Non-exposure group

    Behavioral: None exposure

Interventions

  • Behavioralplastic products

    Environmental pollutants related to plastic products

  • BehavioralNone exposure

    No environmental pollutants related to plastic products

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Within 24 months from the initiation of the first ART cycle

07

Study locations

1 of 1 sites recruiting
  • Reproductive Medicine Center of Xiangya Third Hospital of Central South University
    Changsha, Hunan 410013, China
    Recruiting
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Jul 1, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07384676
Lead sponsor
The Third Xiangya Hospital of Central South University
Responsible party
Peng enuo (Department Director, The Third Xiangya Hospital of Central South University) — Principal investigator
First posted
Feb 3, 2026
Start date
Dec 1, 2024
Primary completion
Dec 31, 2029 (estimated)
Completion
Dec 31, 2034 (estimated)
Last update
Feb 3, 2026

Study contacts

Xingping Zhao
Contact
pengena@163.com
13327215012

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion