Newborns From Patients Treated With ART (Assisted Reproductive Technology)

June 19, 2019 updated by: Yingpu Sun, The First Affiliated Hospital of Zhengzhou University

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

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 450052
        • Recruiting
        • Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All newborns from patients treated with ART in our center.

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Birth weight
Time Frame: At delivery
Weight of newborns recorded in Kilogram
At delivery
Number of newborns with Congenital malformations
Time Frame: At delivery
Any newborns with Congenital malformations will be recorded
At delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Height development of newborns
Time Frame: at age of 1 month, 3 months, 6months, 1 year, 3 years and 6 years
Record the height changes (in centimeters)
at age of 1 month, 3 months, 6months, 1 year, 3 years and 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Zhengzhou University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2010

Primary Completion (Anticipated)

December 31, 2050

Study Completion (Anticipated)

December 31, 2050

Study Registration Dates

First Submitted

June 18, 2019

First Submitted That Met QC Criteria

June 19, 2019

First Posted (Actual)

June 20, 2019

Study Record Updates

Last Update Posted (Actual)

June 20, 2019

Last Update Submitted That Met QC Criteria

June 19, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • RMCZZU-Birth cohort study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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