Epigenetic Safety of Assisted Reproductive Technology

Epigenetic Safety of Various Protocols in Assisted Reproductive Technology

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Infertility
• Intervention / Treatment: Other: Completion questionnaires/providing biological samples

• Study Type: Observational
• Enrollment (Anticipated): 15000

Contacts and Locations

• Study Contact: Name: Dan Zhang, M.D, Ph.D; Phone Number: 86-571-87061501-1008; Email: zhangdan@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Women's Hospital School of Medicine Zhejiang University
      • Contact: Dan Zhang, M.D., Ph.D; Phone Number: 86-571-87061501-1008; Email: zhangdan@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Completion questionnaires/providing biological samples; Participant completes baseline interview at enrollment, then completes questionnaires and provides biological samples at each scheduled study visit.
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.	Other: Completion questionnaires/providing biological samples; Participant completes baseline interview at enrollment, then completes questionnaires and provides biological samples at each scheduled study visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
preterm birth rate	preterm birth is defined as gestational weeks between 28 to 37.	28 gestational weeks to 37 gestational weeks
neonatal complication rate	Neonatal complication includes neonatal respiratory disorders, neonatal cerebral palsy, neonatal encephalopathy and other disease that should been sent into neonatal ICU.	1 day after delivery
pregnancy loss rate	Pregnancy loss is defined as any reason that resulted in failure of an embryo to develop, embryonic or fetal death, or spontaneous expulsion of a pregnancy.	28 gestational weeks in maximum
ectopic pregnancy rate	Ectopic pregnancy is defined as an embryo implanted outside the uterine.	12 gestational weeks in maximum
biochemical pregnancy rate	Biochemical pregnancy is defined as numbers of women with an elevated serum β-hCG level of more than 10 mIU/ml.	2 weeks after embryo transfer
Incidence of moderate to severe ovarian hyperstimulation syndrome(OHSS)	Number of cycles of moderate to severe OHSS/total number of fresh stimulation cycle.	3 months after controlled ovarian hyperstimulation

Collaborators and Investigators

• Sponsor: Women's Hospital School Of Medicine Zhejiang University
• Collaborators: Changhai Hospital; International Peace Maternity and Child Health Hospital
• Investigators: Principal Investigator: Dan Zhang, M.D, Ph.D, Women's Hospital School of Medicine Zhejiang University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 15, 2019
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: August 12, 2019
• First Submitted That Met QC Criteria: August 21, 2019
• First Posted (Actual): August 22, 2019

Study Record Updates

• Last Update Posted (Actual): August 22, 2019
• Last Update Submitted That Met QC Criteria: August 21, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: 2018YFC1005003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No