Clinical trial NCT06786871: ARTLifeLine: Assisted Reproduction Technology (ART) Family Health and Development Trajectory Cohort (ARTLL)
Official title: ARTLifeLine: Assisted Reproduction Technology (ART) Family Health and Development Trajectory Cohort (ARTLL)
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Reproductive Techniques, Assisted
Family
Cohort Studies
Development, Infant
Reproductive Issues
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2025-01-22
Enrollment: 100000
Sex: ALL
Minimum age (years): 0
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Couples who have had or plan IVF fertility treatment and their children. Study is recruitign on a family-by-family basis, including: couples undergoing IVF for a variety of reasons, children born as a result of IVF treatment, and other children in the family

Brief summary: The goal of this observational study is to study the health status of infertile couples and their offspring using assisted reproductive technologies. The main questions it aims to answer are:

1. On the basis of the assisted reproduction birth cohort and related research established by the team in the early stage, further expand the construction of the "tracking cohort of familial health and development using assisted reproduction", combine emerging technologies such as cross-database linking and integration, multi-omics sequencing and classical cohort research design, and carry out long-term longitudinal follow-up across generations, covering the whole life cycle and health in multi-dimension.
2. Build a disease risk prediction model for pregnant women and children with assisted reproduction.
3. Delineate the growth curve and neurobehavioral development trajectory of assisted reproductive offspring at different stages.
4. Evaluate the adolescent fertility potential and risk factors of assisted reproductive offspring.

Detailed description: 1. Recent Research Objectives (Within Five Years):

   Build a risk prediction model for reproductive women and children in assisted reproduction, and identify potential molecular markers with high predictive value to provide epidemiological evidence clues for further basic mechanism research.

   Analyze the health status of natural conception versus assisted reproduction pregnant women and children, growth and developmental curves of fetuses during pregnancy, and early neurobehavioral development levels of children after birth.
2. Medium to Long-Term Research Objectives (Future Research Directions of the Cohort):

Systematically evaluate the long-term effects of infertility and assisted reproductive treatments on the physiological, psychological, individual, and family development of parents and offspring.

Collaborate and share data with other domestic and international health cohorts or databases related to assisted reproduction, to compare and analyze the long-term safety of various assisted reproductive technologies on the health of infertile couples and their offspring.

Eligibility criteria: Inclusion Criteria:

(1) Previous or planned IVF treatment; (2) paper or electronic medical records during fertility treatment are available; (3) Obtain informed consent from the research subject or guardian of the minor.

Exclusion Criteria:

(1) Other assisted reproductive treatment techniques that exclude in vitro fertilization, including guided intercourse, ovulation induction, artificial insemination, etc.; (2) refusal of enrollment; (3) withdraw or abort the study at any time and for any reason.

Primary outcomes:
measure: Health outcomes
timeFrame: 20 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital, Beijing, China
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Jie Qiao, PhD
role: STUDY_CHAIR
affiliation: Peking University Third Hospital
name: Rong Li, PhD
role: STUDY_DIRECTOR
affiliation: Peking University Third Hospital
name: Wei Yuan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Third Hospital
name: Tongyan Han, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Third Hospital
name: Liying Yan, PhD
role: STUDY_DIRECTOR
affiliation: Peking University Third Hospital
name: Yuanyuan Wang, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Third Hospital
name: Rui / Yang, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Third Hospital
name: Xiaohui / Zhu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Third Hospital
name: Lian / Chen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Third Hospital
name: Meihua / Piao, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Third Hospital
name: Yunpu / Cui, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Third Hospital
name: Yanan / Tang, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Third Hospital
name: Chunling / Huang, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Third Hospital
name: Chunmei / Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Third Hospital
name: Linlin / Wang, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Third Hospital
name: Ningning / Pan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Third Hospital
name: Huifeng Shi, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Third Hospital
name: Tianchen / Wu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Third Hospital
name: Wanning / Qiu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Third Hospital
name: Jinfang / Yuan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Third Hospital
name: Hui / Zhang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Third Hospital
name: Qingqing Wang
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Third Hospital
name: Meng Qin
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Third Hospital
name: Ying Kuo
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Third Hospital
name: Wenxi Zhang
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Third Hospital
name: Shuo Guan
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Third Hospital
name: Siming Jiang
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Third Hospital
name: Fei Kong
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Third Hospital
name: Tian Tian, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Third Hospital
name: Lixue Chen
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Third Hospital
name: Yu Fu
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Third Hospital
name: Fang Liu
role: PRINCIPAL_INVESTIGATOR
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