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)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorThe Third Xiangya Hospital of Central South University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

    Biological/Vaccine

    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.

Treatment groups

5,000 Participants
are divided into 1 treatment group
Group A: Environmental exposure and behavioral factorsExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
From embryo transfer to delivery (up to 42 weeks post-transfer)
2

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.

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

Secondary outcomes

1

Number of Participants with Clinical Pregnancy Following ART Treatment

Clinical pregnancy is defined as the presence of at least one intrauterine gestational sac confirmed by transvaginal ultrasound.

Time frame
At 4-6 weeks after embryo transfer
2

Number of Participants with Miscarriage Following ART Treatment

Miscarriage (spontaneous abortion) is defined as pregnancy loss before 20 completed weeks of gestation.

Time frame
From confirmation of clinical pregnancy to before 20 weeks of gestation
3

Number of Participants with Preterm Birth Following ART Treatment

Preterm birth is defined as delivery before 37 completed weeks of gestation.

Time frame
At delivery
4

Number of Participants with Low Birth Weight Infant Following ART Treatment

Low birth weight is defined as birth weight \<2500 g.

Time frame
At delivery

Other outcomes

Sponsors and contacts

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