NCT06786871

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. 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. 2.Build a disease risk prediction model for pregnant women and children with assisted reproduction.
  3. 3.Delineate the growth curve and neurobehavioral development trajectory of assisted reproductive offspring at different stages.
  4. 4.Evaluate the adolescent fertility potential and risk factors of assisted reproductive offspring.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100,000

participants targeted

Target at P75+ for all trials

Timeline
215mo left

Started Jan 2025

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Jan 2025Dec 2043

First Submitted

Initial submission to the registry

June 20, 2023

Completed
1.6 years until next milestone

Study Start

First participant enrolled

January 20, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 22, 2025

Completed
19 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2043

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2043

Last Updated

January 22, 2025

Status Verified

June 1, 2024

Enrollment Period

19 years

First QC Date

June 20, 2023

Last Update Submit

January 19, 2025

Conditions

Reproductive Techniques, AssistedFamilyCohort StudiesDevelopment, InfantReproductive Issues

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

Interventions

IVF treatmentPROCEDURE

Methods or procedures for the in vitro processing of human oocytes, sperm, or embryos for fertility purposes

Couples who have had or plan IVF fertility treatment and their offsprings

Eligibility Criteria

Age0 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability 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

You may qualify if:

  • (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.

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Peking University Third Hospital, Beijing, China

Beijing, Beijing Municipality, 100191, China

Location

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Helping Behavior

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • Jie Qiao, PhD

    Peking University Third Hospital

    STUDY CHAIR

  • Rong Li, PhD

    Peking University Third Hospital

    STUDY DIRECTOR

  • Wei Yuan, PhD

    Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

  • Tongyan Han, PhD

    Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

  • Liying Yan, PhD

    Peking University Third Hospital

    STUDY DIRECTOR

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2023

First Posted

January 22, 2025

Study Start

January 20, 2025

Primary Completion (Estimated)

December 31, 2043

Study Completion (Estimated)

December 31, 2043

Last Updated

January 22, 2025

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)