ARTLifeLine: Assisted Reproduction Technology (ART) Family Health and Development Trajectory Cohort (ARTLL)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Development, Infant; Reproductive Techniques, Assisted; Family; Reproductive Issues; Cohort Studies
• Intervention / Treatment: Procedure: IVF treatment

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.

• Study Type: Observational
• Enrollment (Estimated): 100000

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Peking University Third Hospital
    • Beijing, Beijing, China, 100191
      • Peking University Third Hospital, Beijing, China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Couples who have had or plan IVF fertility treatment and their offsprings; Have performed or plan to undergo IVF fertility treatment; Paper or electronic medical records during fertility treatment are available; Obtain informed consent from the research subject or guardian of the minor	Procedure: IVF treatment; Methods or procedures for the in vitro processing of human oocytes, sperm, or embryos for fertility purposes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health outcomes	Health outcomes for parents and children at different stages(assisted reproduction Treatment stage, pregnancy and childbirth, childhood, adolescence) and dimensions(physiological, psychological, individual and family development) after receiving assisted reproduction treatment.	20 years

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Study Chair: Jie Qiao, PhD, Peking University Third Hospital; Study Director: Rong Li, PhD, Peking University Third Hospital; Principal Investigator: Wei Yuan, PhD, Peking University Third Hospital; Principal Investigator: Tongyan Han, PhD, Peking University Third Hospital; Study Director: Liying Yan, PhD, Peking University Third Hospital; Principal Investigator: Yuanyuan Wang, PhD, Peking University Third Hospital; Principal Investigator: Rui / Yang, PhD, Peking University Third Hospital; Principal Investigator: Xiaohui / Zhu, PhD, Peking University Third Hospital; Principal Investigator: Lian / Chen, PhD, Peking University Third Hospital; Principal Investigator: Meihua / Piao, PhD, Peking University Third Hospital; Principal Investigator: Yunpu / Cui, PhD, Peking University Third Hospital; Principal Investigator: Yanan / Tang, PhD, Peking University Third Hospital; Principal Investigator: Chunling / Huang, PhD, Peking University Third Hospital; Principal Investigator: Chunmei / Zhang, PhD, Peking University Third Hospital; Principal Investigator: Linlin / Wang, PhD, Peking University Third Hospital; Principal Investigator: Ningning / Pan, PhD, Peking University Third Hospital; Principal Investigator: Huifeng Shi, PhD, Peking University Third Hospital; Principal Investigator: Tianchen / Wu, PhD, Peking University Third Hospital; Principal Investigator: Wanning / Qiu, PhD, Peking University Third Hospital; Principal Investigator: Jinfang / Yuan, PhD, Peking University Third Hospital; Principal Investigator: Hui / Zhang, MD, Peking University Third Hospital; Principal Investigator: Qingqing Wang, Peking University Third Hospital; Principal Investigator: Meng Qin, Peking University Third Hospital; Principal Investigator: Ying Kuo, Peking University Third Hospital; Principal Investigator: Wenxi Zhang, Peking University Third Hospital; Principal Investigator: Shuo Guan, Peking University Third Hospital; Principal Investigator: Siming Jiang, Peking University Third Hospital; Principal Investigator: Fei Kong, Peking University Third Hospital; Principal Investigator: Tian Tian, PhD, Peking University Third Hospital; Principal Investigator: Lixue Chen, Peking University Third Hospital; Principal Investigator: Yu Fu, Peking University Third Hospital; Principal Investigator: Fang Liu, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 20, 2025
• Primary Completion (Estimated): December 31, 2043
• Study Completion (Estimated): December 31, 2043

Study Registration Dates

• First Submitted: June 20, 2023
• First Submitted That Met QC Criteria: January 19, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 19, 2025
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: M2023095

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No