The Clinical Cohort Study of Reproductive Health

Fertility Disorders Clinical Trial

Official title:

The Clinical Cohort Study of Reproductive Health

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05164029
• Other study ID #: CSRH
• Status: Not yet recruiting
• Start date: January 1, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: December 2021
• Source: Women's Hospital School Of Medicine Zhejiang University
• Contact: Dan Zhang, M.D, Ph.D
• Phone: 13735808888
• Email: zhangdan[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 3000
• Est. completion date: December 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Assisted Reproductive Technology
• Fertility Disorders

Intervention

Other:
• Completion questionnaires/providing biological samples
Participant completes baseline interview at enrollment, then completes questionnaires and provides biological samples at each scheduled study visit.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Women's Hospital School Of Medicine Zhejiang University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	live birth rate	Number of women with live births / number of women randomized to the specific group.	1 day after delivery
Primary	birth weight	Weight of newborns at delivery.	1 day after delivery
Primary	weight	the weight of offspring	Change from the date of delivery up to 2 years after delivery
Primary	height	the height of offspring	Change from the date of delivery up to 2 years after delivery
Primary	Incidence of mental diseases and metabolic dysfunction		from the date of delivery up to 2 years after delivery
Secondary	implantation rate	Implantation rate was defined as the percentage of fetal heart beat among total transferred embryos at 12 weeks' gestational age.	11-12 weeks after embryo transfer
Secondary	clinical pregnancy rate	Clinical pregnancy was defined as an observation of gestational sac via ultrasonography.	6 weeks after embryo transfer
Secondary	preterm birth rate	preterm birth is defined as gestational weeks between 28 to 37.	28 gestational weeks to 37 gestational weeks
Secondary	neonatal complication rate	Neonatal complication includes neonatal respiratory disorders, neonatal cerebral palsy, neonatal encephalopathy and other disease that should been sent into neonatal ICU.	1 day after delivery