The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013, China
Location status: Recruiting
NCT Number: NCT07641387
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.
Interested in participating?
Request Info18 year–55 year
All sexes
Interventional
Not applicable
Changsha, Hunan, 410013, China
Location status: Recruiting
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:
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;
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 factors include:
Lifestyle behavior patterns include:
Other names: Lifestyle, Behavioral patterns
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.
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.
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.
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.
Time frame: At delivery
Preterm birth is defined as delivery before 37 completed weeks of gestation.
Time frame: At delivery
Low birth weight is defined as birth weight <2500 g.
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.
Contact information is provided by the study sponsor or research team.
The Third Xiangya Hospital of Central South University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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