The Clinical Cohort Study of Reproductive Health

NCT ID: NCT05164029

Last Updated: 2021-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2024-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fertility Disorders Assisted Reproductive Technology Offspring Health

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ART couples

Couples in reproductive age undergoing ART treatment

Completion questionnaires/providing biological samples

Intervention Type OTHER

Participant completes baseline interview at enrollment, then completes questionnaires and provides biological samples at each scheduled study visit.

natural pregnancy couples

Couples who get pregnant naturally

Completion questionnaires/providing biological samples

Intervention Type OTHER

Participant completes baseline interview at enrollment, then completes questionnaires and provides biological samples at each scheduled study visit.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Completion questionnaires/providing biological samples

Participant completes baseline interview at enrollment, then completes questionnaires and provides biological samples at each scheduled study visit.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Women's Hospital School Of Medicine Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dan Zhang

Vice president

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Dan Zhang, M.D, Ph.D

Role: CONTACT

Phone: 13735808888

Email: [email protected]

Ruixue Chen, M.D, Ph.D

Role: CONTACT

Phone: 18868103449

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CSRH

Identifier Type: -

Identifier Source: org_study_id