Clinical trial NCT05164029: The Clinical Cohort Study of Reproductive Health
Official title: The Clinical Cohort Study of Reproductive Health
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fertility Disorders
Assisted Reproductive Technology
Offspring Health
Lead sponsor: Women's Hospital School Of Medicine Zhejiang University
Sponsor class: OTHER
First posted: 2021-12-20
Enrollment: 3000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Couples undergoing treatment for infertility or getting pregnant naturally and wanting to deliver their babies in study hospitals.
2. Men 22-55 years old
3. Women 20 - 45 years old

Exclusion Criteria:

1. Any individual or couple who is outside of age range .
2. Any couple who don't plan to complete their pregnancy check-up or deliver their babies in study hospitals.
3. Any couples had participated in other clinical studies.

Primary outcomes:
measure: live birth rate
timeFrame: 1 day after delivery
measure: birth weight
timeFrame: 1 day after delivery
measure: weight
timeFrame: Change from the date of delivery up to 2 years after delivery
measure: height
timeFrame: Change from the date of delivery up to 2 years after delivery
measure: Incidence of mental diseases and metabolic dysfunction
timeFrame: from the date of delivery up to 2 years after delivery
Secondary outcomes:
measure: implantation rate
timeFrame: 11-12 weeks after embryo transfer
measure: clinical pregnancy rate
timeFrame: 6 weeks after embryo transfer
measure: preterm birth rate
timeFrame: 28 gestational weeks to 37 gestational weeks
measure: neonatal complication rate
timeFrame: 1 day after delivery
Other outcomes:
Locations:
Study officials:
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