Newborns From Patients Treated With ART (Assisted Reproductive Technology)

Recruiting

• Conditions: Health Related

• Registration Number: NCT03993158
• Lead Sponsor: The First Affiliated Hospital of Zhengzhou University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2010-01-01
• Status Verified: 2019-06
• Study First Submitted: 2019-06-18
• Study First Submitted QC: 2019-06-19
• Last Update Submitted: 2019-06-19
• Study First Posted: 2019-06-20
• Last Update Posted: 2019-06-20
• Primary Completion: 2050-12-31
• Study Completion: 2050-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

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

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Birth weight	At delivery	Weight of newborns recorded in Kilogram
Number of newborns with Congenital malformations	At delivery	Any newborns with Congenital malformations will be recorded

Secondary Outcome Measures

Name	Time	Method
Height development of newborns	at age of 1 month, 3 months, 6months, 1 year, 3 years and 6 years	Record the height changes (in centimeters)

Trial Locations

Locations (1)

Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China