Infertility, Infertility Assisted Reproductive Technology, Infertility (IVF Patients)
Conditions
Keywords
environmental pollutants, Assisted Reproductive Technology, prospective cohort, life-style, risk factor, social factor
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.
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;
Interventions
BEHAVIORALLife 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.
BIOLOGICALEnvironmental 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.
Sponsors
The Third Xiangya Hospital of Central South University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Live Birth Following Assisted Reproductive Technology (ART) Treatment | 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. |
| Number of Participants with ART Treatment Failure (Composite Outcome) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Clinical Pregnancy Following ART Treatment | 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. |
| Number of Participants with Miscarriage Following ART Treatment | 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. |
| Number of Participants with Preterm Birth Following ART Treatment | At delivery | Preterm birth is defined as delivery before 37 completed weeks of gestation. |
| Number of Participants with Low Birth Weight Infant Following ART Treatment | At delivery | Low birth weight is defined as birth weight \<2500 g. |
| Number of Participants with Congenital Anomalies in Newborns Following ART Treatment | 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. |
Countries
China
Contacts
CONTACTXingping Zhao
Outcome results
None listed