The Clinical Cohort Study of Reproductive Health
- Conditions
- Fertility DisordersOffspring HealthAssisted Reproductive Technology
- Interventions
- Other: Completion questionnaires/providing biological samples
- Registration Number
- NCT05164029
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 3000
- 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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description ART couples Completion questionnaires/providing biological samples Couples in reproductive age undergoing ART treatment natural pregnancy couples Completion questionnaires/providing biological samples Couples who get pregnant naturally
- Primary Outcome Measures
Name Time Method birth weight 1 day after delivery Weight of newborns at delivery.
height Change from the date of delivery up to 2 years after delivery the height of offspring
Incidence of mental diseases and metabolic dysfunction from the date of delivery up to 2 years after delivery weight Change from the date of delivery up to 2 years after delivery the weight of offspring
live birth rate 1 day after delivery Number of women with live births / number of women randomized to the specific group.
- Secondary Outcome Measures
Name Time Method clinical pregnancy rate 6 weeks after embryo transfer Clinical pregnancy was defined as an observation of gestational sac via ultrasonography.
preterm birth rate 28 gestational weeks to 37 gestational weeks preterm birth is defined as gestational weeks between 28 to 37.
neonatal complication rate 1 day after delivery Neonatal complication includes neonatal respiratory disorders, neonatal cerebral palsy, neonatal encephalopathy and other disease that should been sent into neonatal ICU.
implantation rate 11-12 weeks after embryo transfer Implantation rate was defined as the percentage of fetal heart beat among total transferred embryos at 12 weeks' gestational age.