NCT07641387 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)
| NCT ID | NCT07641387 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Third Xiangya Hospital of Central South University |
| Condition | Infertility |
| Study Type | INTERVENTIONAL |
| Enrollment | 5,000 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2030-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 5,000 participants in total. It began in 2025-04-01 with a primary completion date of 2030-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07641387 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Infertility. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07641387 currently recruiting?
Yes, NCT07641387 is actively recruiting participants. Contact the research team at zxp8846@126.com for enrollment information.
Where is the NCT07641387 trial being conducted?
This trial is being conducted at Changsha, China.
Who is sponsoring the NCT07641387 clinical trial?
NCT07641387 is sponsored by The Third Xiangya Hospital of Central South University. The trial plans to enroll 5,000 participants.