The Clinical Cohort Study of Reproductive Health
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Fertility Disorders
- Sponsor
- Women's Hospital School Of Medicine Zhejiang University
- Enrollment
- 3000
- Primary Endpoint
- birth weight
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
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
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.
Investigators
Dan Zhang
Vice president
Women's Hospital School Of Medicine Zhejiang University
Eligibility Criteria
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.
Outcomes
Primary Outcomes
birth weight
Time Frame: 1 day after delivery
Weight of newborns at delivery.
height
Time Frame: Change from the date of delivery up to 2 years after delivery
the height of offspring
Incidence of mental diseases and metabolic dysfunction
Time Frame: from the date of delivery up to 2 years after delivery
weight
Time Frame: Change from the date of delivery up to 2 years after delivery
the weight of offspring
live birth rate
Time Frame: 1 day after delivery
Number of women with live births / number of women randomized to the specific group.
Secondary Outcomes
- clinical pregnancy rate(6 weeks after embryo transfer)
- preterm birth rate(28 gestational weeks to 37 gestational weeks)
- implantation rate(11-12 weeks after embryo transfer)
- neonatal complication rate(1 day after delivery)