The Clinical Cohort Study of Reproductive Health

NCT05164029 | Unknown DMC

• 1 other identifier: CSRH
• Study Type: observational
• Target: 3,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Fertility Disorders; Assisted Reproductive Technology; Offspring Health

Outcome Measures

Primary Outcomes (5)

• live birth rate

  Number of women with live births / number of women randomized to the specific group.

  1 day after delivery

• birth weight

  Weight of newborns at delivery.

  1 day after delivery

• weight

  the weight of offspring

  Change from the date of delivery up to 2 years after delivery

• height

  the height of offspring

  Change from the date of delivery up to 2 years after delivery

• Incidence of mental diseases and metabolic dysfunction

  from the date of delivery up to 2 years after delivery

Secondary Outcomes (4)

• implantation rate

  11-12 weeks after embryo transfer

• clinical pregnancy rate

  6 weeks after embryo transfer

• preterm birth rate

  28 gestational weeks to 37 gestational weeks

• neonatal complication rate

  1 day after delivery

Study Arms (2)

ART couples

Couples in reproductive age undergoing ART treatment

Other: Completion questionnaires/providing biological samples

natural pregnancy couples

Couples who get pregnant naturally

Other: Completion questionnaires/providing biological samples

Interventions

Completion questionnaires/providing biological samples OTHER

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

ART couples; natural pregnancy couples

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Women's Hospital School Of Medicine Zhejiang University: lead

Central Study Contacts

Dan Zhang, M.D, Ph.D

CONTACT

13735808888; zhangdan@zju.edu.cn

Ruixue Chen, M.D, Ph.D

CONTACT

18868103449; 12018294@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice president

Study Record Dates

• First Submitted: December 9, 2021
• First Posted: December 20, 2021
• Study Start: January 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 20, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share