Epigenetic Safety of Assisted Reproductive Technology

Infertility Clinical Trial

Official title:

Epigenetic Safety of Various Protocols in Assisted Reproductive Technology

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04065945
• Other study ID #: 2018YFC1005003
• Status: Not yet recruiting
• Start date: September 15, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2019
• Source: Women's Hospital School Of Medicine Zhejiang University
• Contact: Dan Zhang, M.D, Ph.D
• Phone: 86-571-87061501-1008
• Email: zhangdan[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15000
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility

Intervention

Other:
• Completion questionnaires/providing biological samples
Participant completes baseline interview at enrollment, then completes questionnaires and provides biological samples at each scheduled study visit.

Locations

Country	Name	City	State
China	Women's Hospital School of Medicine Zhejiang University	Hangzhou	Zhejiang

Sponsors (3)

Lead Sponsor	Collaborator
Women's Hospital School Of Medicine Zhejiang University	Changhai Hospital, International Peace Maternity and Child Health Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	birth weight	Weight of newborns at delivery.	1 day after delivery
Primary	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
Primary	clinical pregnancy rate	Clinical pregnancy was defined as an observation of gestational sac via ultrasonography.	6 weeks after embryo transfer
Primary	congenital anomalies rate	Congenital anomaly included deformity and development abnormality of any organs or systems.	1 day after delivery
Primary	weight	the weight of offspring	Change from the date of delivery up to 4 years after delivery
Primary	height	the height of offspring	Change from the date of delivery up to 4 years after delivery
Primary	Incidence of mental diseases and metabolic dysfunction		4 years after delivery
Secondary	biochemical pregnancy rate	Biochemical pregnancy is defined as numbers of women with an elevated serum ß-hCG level of more than 10 mIU/ml.	2 weeks after embryo transfer
Secondary	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
Secondary	ectopic pregnancy rate	Ectopic pregnancy is defined as an embryo implanted outside the uterine.	12 gestational weeks in maximum
Secondary	preterm birth rate	preterm birth is defined as gestational weeks between 28 to 37.	28 gestational weeks to 37 gestational weeks
Secondary	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
Secondary	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