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Recruiting NCT03993158

Newborns From Patients Treated With ART (Assisted Reproductive Technology)

Observational Health Related

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Health Related. Basic parameters: 0 Weeks — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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)

Overview

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.

Primary outcome measures

  • Birth weight [Time frame: At delivery]
  • Number of newborns with Congenital malformations [Time frame: At delivery]
Secondary outcome measures (1)
  • Height development of newborns [Time frame: at age of 1 month, 3 months, 6months, 1 year, 3 years and 6 years]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

\-

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University — Zhengzhou

Publications

  • 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. PMID 29164811
  • 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. PMID 18550992

Identifiers

NCT: NCT03993158 · RMCZZU-Birth cohort study

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗