The Clinical Cohort Study of Reproductive Health

Women's Hospital School Of Medicine Zhejiang University

Status: Not yet enrolling

Conditions: Fertility Disorders; Offspring Health; Assisted Reproductive Technology

Treatments: Other: Completion questionnaires/providing biological samples

Study type: Observational

Funder types: Other

Identifiers

NCT05164029

CSRH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

3,000 participants in 2 patient groups

ART couples

Description:

Couples in reproductive age undergoing ART treatment

Treatment:

Other: Completion questionnaires/providing biological samples

natural pregnancy couples

Description:

Couples who get pregnant naturally

Treatment:

Other: Completion questionnaires/providing biological samples