Reproductive Techniques, AssistedNCT06786871
ARTLifeLine: Assisted Reproduction Technology (ART) Family Health and Development Trajectory Cohort (ARTLL)
An observational study of Reproductive Techniques, Assisted and Family, run by Peking University Third Hospital at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 50 years
- Conditions the study is for
- Reproductive Techniques, Assisted, Family, Cohort Studies
- What is being tested?
- IVF treatment
- Type of treatment
- Surgery or procedure
- How many people
- 100,000 participants
- Where
- 2 sitesChina
- Study dates
- 20 Jan 2025to 31 Dec 2043
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Peking University Third Hospital, Beijing, China
Beijing, Beijing Municipality, 100191
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
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:
- 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.
- Build a disease risk prediction model for pregnant women and children with assisted reproduction.
- Delineate the growth curve and neurobehavioral development trajectory of assisted reproductive offspring at different stages.
- Evaluate the adolescent fertility potential and risk factors of assisted reproductive offspring.
Read the detailed description
- 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.
- 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.
- Conditions
- Reproductive Techniques, Assisted, Family, Cohort Studies, Development, Infant, Reproductive Issues
- Being tested
- IVF treatment
- Medical subject headings
- Helping Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVF treatmentProcedure or surgery
Methods or procedures for the in vitro processing of human oocytes, sperm, or embryos for fertility purposes
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: IVF treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start20 Jan 2025 (estimated)
- Primary completion31 Dec 2043 (estimated)
- Study completion31 Dec 2043 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reproductive Techniques, AssistedStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jie Qiao, PhD, Study chair, Peking University Third HospitalRong Li, PhD, Study director, Peking University Third HospitalWei Yuan, PhD, Principal investigator, Peking University Third HospitalTongyan Han, PhD, Principal investigator, Peking University Third HospitalLiying Yan, PhD, Study director, Peking University Third HospitalYuanyuan Wang, PhD, Principal investigator, Peking University Third HospitalRui / Yang, PhD, Principal investigator, Peking University Third HospitalXiaohui / Zhu, PhD, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06786871
- Sponsor's protocol ID
- M2023095
- Status last verified
- Jun 2024
- First submitted
- 20 Jun 2023
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ARTLifeLine: Assisted Reproduction Technology (ART) Family Health and Development Trajectory Cohort (ARTLL)
- ClinicalTrials.gov ID
- NCT06786871
- Acronym / sponsor ID
- M2023095
- Conditions
- Reproductive Techniques, Assisted, Family, Cohort Studies, Development, Infant, Reproductive Issues
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 20 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2043 (estimated)
- Study completion
- 31 Dec 2043 (estimated)
- First posted
- 22 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- Build a disease risk prediction model for pregnant women and children with assisted reproduction.
- Delineate the growth curve and neurobehavioral development trajectory of assisted reproductive offspring at different stages.
- Evaluate the adolescent fertility potential and risk factors of assisted reproductive offspring.
Detailed description
- 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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Couples who have had or plan IVF fertility treatment and their offsprings | – | Procedure: IVF treatmentHave 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 |
Who may qualify
- Ages
- 0 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IVF treatmentMethods or procedures for the in vitro processing of human oocytes, sperm, or embryos for fertility purposes | Procedure or surgery | Couples who have had or plan IVF fertility treatment and their offsprings |
Primary outcome
Health outcomes
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jie Qiao, PhD study chair
Peking University Third Hospital
Rong Li, PhD study director
Peking University Third Hospital
Wei Yuan, PhD principal investigator
Peking University Third Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Reproductive Techniques, Assisted and Family, run by Peking University Third Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health outcomes (time frame: 20 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.