Newborns From Patients Treated With ART (Assisted Reproductive Technology)

Health Related Clinical Trial

Official title:

Prospective Cohort Study for Newborns From Patients Treated With ART in Clinical Reproductive Medicine Management System/Electronic Medical Record Cohort Database (CCRM/EMRCD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03993158
• Other study ID #: RMCZZU-Birth cohort study
• Status: Recruiting
• Start date: January 1, 2010
• Est. completion date: December 31, 2050

Study information

• Verified date: June 2019
• Source: The First Affiliated Hospital of Zhengzhou University
• Contact: Lanlan Fang, M.D.
• Phone: 13673355291
• Email: fanglly[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The Prospective Cohort Study for Newborns from patients treated with ART was set up to investigate the short- and long-term health consequences in Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University, China.

Description:

Since the last twenty years, thousands of babies were born from infertile couples treated in our center. However, the short, and especially the long term prognosis of these children were barely known.

Since last decade, Clinical Reproductive Medicine Management System/Electronic Medical Record Cohort Database (CCRM/EMRCD) has been used in Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University, and Henan Province Key Laboratory for Reproduction and Genetics. Information of patients (POI, PCOS, Endometriosis, azoospermia, ect) were recorded comprehensively. In addition, information of each newborn from our center has also been kept in CCRM/EMRCD. The current project plans to recruit these newborn babies in our center. Biological samples, questionnaires and short/long term health data will be collected. The study is aimed to provide evidence for Newborns from patients treated with ART prognosis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 31, 2050
• Est. primary completion date: December 31, 2050
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 40 Years

Eligibility

Inclusion Criteria:

• All newborns from patients treated with ART in our center.

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Health Related

Locations

Country	Name	City	State
China	Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Zhengzhou University

Country where clinical trial is conducted

China, 

References & Publications (2)

Giorgione V, Parazzini F, Fesslova V, Cipriani S, Candiani M, Inversetti A, Sigismondi C, Tiberio F, Cavoretto P. Congenital heart defects in IVF/ICSI pregnancy: systematic review and meta-analysis. Ultrasound Obstet Gynecol. 2018 Jan;51(1):33-42. doi: 10.1002/uog.18932. Review. — View Citation

Wagenaar K, Huisman J, Cohen-Kettenis PT, Delemarre-van de Waal HA. An overview of studies on early development, cognition, and psychosocial well-being in children born after in vitro fertilization. J Dev Behav Pediatr. 2008 Jun;29(3):219-30. doi: 10.1097/DBP.0b013e318173a575. Review. Erratum in: J Dev Behav Pediatr. 2008 Oct;29(5):410. Adelemarre-van De Waal, Henriette [corrected to Delemarre-van de Waal, Henriette A]. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Birth weight	Weight of newborns recorded in Kilogram	At delivery
Primary	Number of newborns with Congenital malformations	Any newborns with Congenital malformations will be recorded	At delivery
Secondary	Height development of newborns	Record the height changes (in centimeters)	at age of 1 month, 3 months, 6months, 1 year, 3 years and 6 years