Clinical trial NCT02190422: Effect of Assisted Reproductive Technology on Cardiac Development in Childhood Assessed by Echocardiography
Official title: Effect of Assisted Reproductive Technology on Cardiac Development in Childhood Assessed by Echocardiography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Assisted Reproductive Technology
Keywords: reproductive technologies, assisted
echocardiography
cardiology
pediatrics
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2014-07-15
Enrollment: 200
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ART group will be ART children conceived in Clinical Centre of Reproductive Medicine and born in Maternal-Fetal Medicine Unit (MFMU). The controls will be the spontaneous conception children born in the MFMU during the same period as ART group for prenatal screening and subsequent delivery.

Brief summary: Assisted reproductive technology (ART) has extensively allowed pregnancy for infertile couples. However, the long-term effect of ART exposure on cardiovascular development and potential association with ART procedure and parental factors is confused. The aim is to shed more light on the pattern and extent of cardiovascular developmental alteration among ART children and its association with potential confounders.

Detailed description: A historic cohort study was designed with prospective follow-up of ART children conceived in the Clinical Centre of Reproductive Medicine (CCRM) and born in Maternal-Fetal Medicine Unit (MFMU) of First Affiliated Hospital of Nanjing Medical University (FAHNMU) from 1 January 2002 to 31 December 2012.

The present design is a prospective single-center study in FAHNMU. ART group will be recruited by a non-random, consecutive sample on the basis of the unique personal identification number assigned to ART children conceived in CCRM and born in MFMU.

The controls will be recruited by a non-random, consecutive sample on the basis of the spontaneous conception population attending the MFMU of FAHNMU during the same period as ART group for prenatal screening and subsequent delivery considering their age.

Eligibility criteria: Inclusion Criteria:

* the capability of complete examination of transthoracic echocardiography
* the absence of complex cardiac malformations and systematic diseases.

Exclusion Criteria:

* the presence of a history of systemic diseases, frequent arrhythmias, and critical acquired heart diseases,
* the presence of the background of familiar cardiomyopathy in their family,
* limited acquisitions of echocardiographic imaging
* poor image quality for assessment.

Primary outcomes:
measure: cardiovascular geometric morphology between controls and ART children
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Secondary outcomes:
measure: cardiac function between controls and ART children
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Philips Ultrasound
state: Jiangsu
Study officials:
References:
citation: Liu H, Zhang Y, Gu HT, Feng QL, Liu JY, Zhou J, Yan F. Association between assisted reproductive technology and cardiac alteration at age 5 years. JAMA Pediatr. 2015 Jun;169(6):603-5. doi: 10.1001/jamapediatrics.2015.0214. No abstract available.