The Clinical Cohort Study of Reproductive Health

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Clinical Cohort Study of Reproductive Health

Conditions
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Fertility Disorders, Assisted Reproductive Technology, Offspring Health

Intervention / Treatment
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* Other: Completion questionnaires/providing biological samples


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Couples undergoing treatment for infertility or getting pregnant naturally and wanting to deliver their babies in study hospitals. Men 22-55 years old Women 20 - 45 years old Exclusion Criteria: Any individual or couple who is outside of age range . Any couple who don't plan to complete their pregnancy check-up or deliver their babies in study hospitals. Any couples had participated in other clinical studies.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ART couples<br>Couples in reproductive age undergoing ART treatment | Other: Completion questionnaires/providing biological samples<br>* Participant completes baseline interview at enrollment, then completes questionnaires and provides biological samples at each scheduled study visit.<br>|
| natural pregnancy couples<br>Couples who get pregnant naturally | Other: Completion questionnaires/providing biological samples<br>* Participant completes baseline interview at enrollment, then completes questionnaires and provides biological samples at each scheduled study visit.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |