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The study will conduct a multicenter prospective clinical cohort study to collect comprehensive health information and essential specimens from pre-pregnancy to postpartum offspring development. We will combine the reproductive medicine with the big data technologies and cloud computing to explore the key factors which will induce the occurrence the reproductive disorders and effect the health of women and offspring. Based on the discovery of the cohort study, we will construct a prediction model for improvement of ART,optimizing the effectiveness and safety of ART.
Safeguarding the health of women and children is an important part of The Healthy China 2030 Plan. Precisely controlling the fertility process will help to improve the quality of national population. Lots of studies have reported that environmental exposure, lifestyle, diet and other factors are related to fertility, female pregnancy and postpartum health, and offspring development. Some studies have found that assisted reproductive technology (ART) represents an increased risk of epigenetic-related diseases or birth defects.
The study will conduct a multicenter prospective clinical cohort study to collect comprehensive health information and essential specimens from pre-pregnancy to postpartum offspring development. We will combine the reproductive medicine with the big data technologies and cloud computing to explore the key factors which will induce the occurrence the reproductive disorders and effect the health of women and offspring. Based on the discovery of the cohort study, we will construct a prediction model for improvement of ART,optimizing the effectiveness and safety of ART.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ART couples | Couples in reproductive age undergoing ART treatment |
| |
| natural pregnancy couples | Couples who get pregnant naturally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Completion questionnaires/providing biological samples | Other | Participant completes baseline interview at enrollment, then completes questionnaires and provides biological samples at each scheduled study visit. |
| Measure | Description | Time Frame |
|---|---|---|
| live birth rate | Number of women with live births / number of women randomized to the specific group. | 1 day after delivery |
| birth weight | Weight of newborns at delivery. | 1 day after delivery |
| weight | the weight of offspring | Change from the date of delivery up to 2 years after delivery |
| height | the height of offspring | Change from the date of delivery up to 2 years after delivery |
| Incidence of mental diseases and metabolic dysfunction | from the date of delivery up to 2 years after delivery |
| Measure | Description | Time Frame |
|---|---|---|
| implantation rate | Implantation rate was defined as the percentage of fetal heart beat among total transferred embryos at 12 weeks' gestational age. | 11-12 weeks after embryo transfer |
| clinical pregnancy rate |
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Inclusion Criteria:
Exclusion Criteria:
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Study subjects will be recruited from couples seeking treatment of infertility or getting pregnant naturally and wanting to deliver their babies in the study hospitals. Men must be at least 22 years old and women must be at least 20 years to participate in the study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dan Zhang, M.D, Ph.D | Contact | 13735808888 | zhangdan@zju.edu.cn | |
| Ruixue Chen, M.D, Ph.D | Contact | 18868103449 | 12018294@zju.edu.cn |
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All data relevant to the study will be generated in the article or uploaded as supplementary information. Deidentified participant data will be available from Dr. Dan Zhang (zhangdan@zju.edu.cn) on a reasonable request. Protocols and statistical analysis plans will be included as supplementary information.
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Clinical pregnancy was defined as an observation of gestational sac via ultrasonography.
| 6 weeks after embryo transfer |
| preterm birth rate | preterm birth is defined as gestational weeks between 28 to 37. | 28 gestational weeks to 37 gestational weeks |
| neonatal complication rate | Neonatal complication includes neonatal respiratory disorders, neonatal cerebral palsy, neonatal encephalopathy and other disease that should been sent into neonatal ICU. | 1 day after delivery |