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

• Conditions: Reproductive Techniques, Assisted; Family; Cohort Studies; Development, Infant; Reproductive Issues

• Registration Number: NCT06786871
• Lead Sponsor: Peking University Third Hospital

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.

Study Timeline

• Study First Submitted: 2023-06-20
• Status Verified: 2024-06
• Study First Submitted QC: 2025-01-19
• Last Update Submitted: 2025-01-19
• Study Start: 2025-01-20
• Study First Posted: 2025-01-22
• Last Update Posted: 2025-01-22
• Primary Completion: 2043-12-31
• Study Completion: 2043-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Health outcomes	20 years	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.

Trial Locations

Locations (2)

Peking University Third Hospital, Beijing, China; 🇨🇳 Beijing, Beijing, China

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China