Epigenetic Safety of Assisted Reproductive Technology

Not yet recruiting

• Conditions: Infertility
• Interventions: Other: Completion questionnaires/providing biological samples

• Registration Number: NCT04065945
• Lead Sponsor: Women's Hospital School Of Medicine Zhejiang University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-08
• Study First Submitted: 2019-08-12
• Study First Submitted QC: 2019-08-21
• Last Update Submitted: 2019-08-21
• Study First Posted: 2019-08-22
• Last Update Posted: 2019-08-22
• Study Start: 2019-09-15
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 15000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Couples getting pregnant naturally	Completion questionnaires/providing biological samples	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.
Couples undergoing ART treatment	Completion questionnaires/providing biological samples	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.

Primary Outcome Measures

Name	Time	Method
live birth rate	1 day after delivery	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.
birth weight	1 day after delivery	Weight of newborns at delivery.
implantation rate	11-12 weeks after embryo transfer	Implantation rate was defined as the percentage of fetal heart beat among total transferred embryos at 12 weeks' gestational age.
congenital anomalies rate	1 day after delivery	Congenital anomaly included deformity and development abnormality of any organs or systems.
weight	Change from the date of delivery up to 4 years after delivery	the weight of offspring
Incidence of mental diseases and metabolic dysfunction	4 years after delivery
clinical pregnancy rate	6 weeks after embryo transfer	Clinical pregnancy was defined as an observation of gestational sac via ultrasonography.
height	Change from the date of delivery up to 4 years after delivery	the height of offspring

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Women's Hospital School of Medicine Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China