Epigenetic Safety of Assisted Reproductive Technology
Epigenetic Safety of Various Protocols in Assisted Reproductive Technology
1 other identifier
observational
15,000
1 country
1
Brief Summary
The primary purpose of the study is to investigate the relationship between different protocols of assisted reproductive technology and the epigenetic safety of the offspring. Different interventions of assisted reproductive technology include controlled ovarian hyperstimulation (COH), in vitro embryo culture, in vitro fertilization(IVF), intracytoplasmic sperm injection(ICSI), frozen-thawed embryo transfer(FET), preimplantation genetic testing(PGT). The investigators are also interested in the relationship between pregnancy outcomes in ART or natural conception and environmental, nutritional and lifestyle factors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 12, 2019
CompletedFirst Posted
Study publicly available on registry
August 22, 2019
CompletedStudy Start
First participant enrolled
September 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedAugust 22, 2019
August 1, 2019
5.3 years
August 12, 2019
August 21, 2019
Conditions
Outcome Measures
Primary Outcomes (8)
live birth rate
Number of women with live births / number of women randomized to the specific group.Live birth is defined as the delivery of any viable infant at 28 weeks or more of gestation after our interventions.
1 day after delivery
birth weight
Weight of newborns at delivery.
1 day after delivery
implantation rate
Implantation rate was defined as the percentage of fetal heart beat among total transferred embryos at 12 weeks' gestational age.
11-12 weeks after embryo transfer
clinical pregnancy rate
Clinical pregnancy was defined as an observation of gestational sac via ultrasonography.
6 weeks after embryo transfer
congenital anomalies rate
Congenital anomaly included deformity and development abnormality of any organs or systems.
1 day after delivery
weight
the weight of offspring
Change from the date of delivery up to 4 years after delivery
height
the height of offspring
Change from the date of delivery up to 4 years after delivery
Incidence of mental diseases and metabolic dysfunction
4 years after delivery
Secondary Outcomes (6)
biochemical pregnancy rate
2 weeks after embryo transfer
pregnancy loss rate
28 gestational weeks in maximum
ectopic pregnancy rate
12 gestational weeks in maximum
preterm birth rate
28 gestational weeks to 37 gestational weeks
Incidence of moderate to severe ovarian hyperstimulation syndrome(OHSS)
3 months after controlled ovarian hyperstimulation
- +1 more secondary outcomes
Study Arms (2)
Couples undergoing ART treatment
Couples in reproductive age undergoing ART treatment in Women's Hospital School of Medicine Zhejiang University, The International Peace Maternity \& Child Health Hospital, and Changhai Hospital of Shanghai.
Couples getting pregnant naturally
Couples who get pregnant naturally and want to deliver the babies in Women's Hospital School of Medicine Zhejiang University, The International Peace Maternity \& Child Health Hospital, and Changhai Hospital of Shanghai.
Interventions
Participant completes baseline interview at enrollment, then completes questionnaires and provides biological samples at each scheduled study visit.
Eligibility Criteria
Study subjects will be recruited from couples seeking treatment of infertility or getting pregnant naturally and wanting to deliver their babies at the Women's Hospital School of Medicine Zhejiang University. Men must be at least 22 years old and women must be at least 20 years to participate in the study.
You may qualify if:
- Couples undergoing treatment for infertility or getting pregnant naturally and wanting to deliver their babies in Women's Hospital School of Medicine Zhejiang University, The International Peace Maternity \& Child Health Hospital, and Changhai Hospital of Shanghai.
- Men 22-55 years old
- Women 20 - 45 years old
You may not qualify if:
- Any individual or couple who is outside of age range .
- Any couple who don't plan to complete their pregnancy check-up or deliver their babies in Women's Hospital School of Medicine Zhejiang University, The International Peace Maternity \& Child Health Hospital, or Changhai Hospital of Shanghai.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Women's Hospital School of Medicine Zhejiang University
Hangzhou, Zhejiang, China
Biospecimen
Whole blood, urine, granulosa cells, follicular fluid , sperm and semen ,abandoned egg or embryo,villi, decidua, placenta, amniotic fluid, umbilical cord blood, and buccal swabs of the offspring.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dan Zhang, M.D, Ph.D
Women's Hospital School Of Medicine Zhejiang University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 12, 2019
First Posted
August 22, 2019
Study Start
September 15, 2019
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
August 22, 2019
Record last verified: 2019-08