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)
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.
調査の概要
詳細な説明
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:
- 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.
- 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.
- 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.
- 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;
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Xingping Zhao
- 電話番号：+86 13327215012
- メール：zxp8846@126.com
研究場所
-
-
Hunan
-
Changsha、Hunan、中国、410013
- 募集
- The Third XIANGYA Hospital of Central South University
-
コンタクト：
- Xingping Zhao
- 電話番号：+86 13327215012
-
-
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Environmental exposure and behavioral factors
Environmental factors include: traditional air pollutants, plastic products, decoration conditions, and the vicinity of petrochemical plants or waste incineration stations Behavioral factors include: diet and nutrition, daily routine, working environment, living environment, and personal care.
|
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:
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Participants with Live Birth Following Assisted Reproductive Technology (ART) Treatment
時間枠：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.
|
From embryo transfer to delivery (up to 42 weeks post-transfer)
|
|
Number of Participants with ART Treatment Failure (Composite Outcome)
時間枠：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.
|
From the start of ART treatment to 42 weeks after embryo transfer
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Participants with Clinical Pregnancy Following ART Treatment
時間枠：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.
|
At 4-6 weeks after embryo transfer
|
|
Number of Participants with Miscarriage Following ART Treatment
時間枠：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.
|
From confirmation of clinical pregnancy to before 20 weeks of gestation
|
|
Number of Participants with Preterm Birth Following ART Treatment
時間枠：At delivery
|
Preterm birth is defined as delivery before 37 completed weeks of gestation.
|
At delivery
|
|
Number of Participants with Low Birth Weight Infant Following ART Treatment
時間枠：At delivery
|
Low birth weight is defined as birth weight <2500 g.
|
At delivery
|
|
Number of Participants with Congenital Anomalies in Newborns Following ART Treatment
時間枠：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.
|
From birth up to 28 days postpartum
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。