Clinical trial NCT04065945: Epigenetic Safety of Assisted Reproductive Technology
Official title: Epigenetic Safety of Various Protocols in Assisted Reproductive Technology
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility
Lead sponsor: Women's Hospital School Of Medicine Zhejiang University
Sponsor class: OTHER
Collaborators: name: International Peace Maternity and Child Health Hospital
name: Changhai Hospital
First posted: 2019-08-22
Enrollment: 15000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: Inclusion Criteria:

1. 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.
2. Men 22-55 years old
3. Women 20 - 45 years old

Exclusion Criteria:

1. Any individual or couple who is outside of age range .
2. 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.

Primary outcomes:
measure: live birth rate
timeFrame: 1 day after delivery
measure: birth weight
timeFrame: 1 day after delivery
measure: implantation rate
timeFrame: 11-12 weeks after embryo transfer
measure: clinical pregnancy rate
timeFrame: 6 weeks after embryo transfer
measure: congenital anomalies rate
timeFrame: 1 day after delivery
measure: weight
timeFrame: Change from the date of delivery up to 4 years after delivery
measure: height
timeFrame: Change from the date of delivery up to 4 years after delivery
measure: Incidence of mental diseases and metabolic dysfunction
timeFrame: 4 years after delivery
Secondary outcomes:
measure: biochemical pregnancy rate
timeFrame: 2 weeks after embryo transfer
measure: pregnancy loss rate
timeFrame: 28 gestational weeks in maximum
measure: ectopic pregnancy rate
timeFrame: 12 gestational weeks in maximum
measure: preterm birth rate
timeFrame: 28 gestational weeks to 37 gestational weeks
measure: Incidence of moderate to severe ovarian hyperstimulation syndrome(OHSS)
timeFrame: 3 months after controlled ovarian hyperstimulation
measure: neonatal complication rate
timeFrame: 1 day after delivery
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Women's Hospital School of Medicine Zhejiang University
state: Zhejiang
Study officials:
affiliation: Women's Hospital School Of Medicine Zhejiang University
name: Dan Zhang, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: