NCT03993158

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
299mo left

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress40%
Jan 2010Dec 2050

Study Start

First participant enrolled

January 1, 2010

Completed
9.5 years until next milestone

First Submitted

Initial submission to the registry

June 18, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 20, 2019

Completed
31.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2050

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2050

Last Updated

May 27, 2026

Status Verified

May 1, 2026

Enrollment Period

41 years

First QC Date

June 18, 2019

Last Update Submit

May 24, 2026

Conditions

Health Related

Outcome Measures

Primary Outcomes (2)

  • Birth weight

    Weight of newborns recorded in Kilogram

    At delivery

  • Number of newborns with Congenital malformations

    Any newborns with Congenital malformations will be recorded

    At delivery

Secondary Outcomes (1)

  • Height development of newborns

    at age of 1 month, 3 months, 6months, 1 year, 3 years and 6 years

Eligibility Criteria

Age0 Weeks - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All newborns from patients treated with ART in our center.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

Related 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.

    PMID: 29164811BACKGROUND

  • 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: 18550992BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood serum; follicular fluid

Central Study Contacts

Zhiqin Bu, M.D.

CONTACT

037167967161rmczzu@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor of Reproductive Medical Center

Study Record Dates

First Submitted

June 18, 2019

First Posted

June 20, 2019

Study Start

January 1, 2010

Primary Completion (Estimated)

December 31, 2050

Study Completion (Estimated)

December 31, 2050

Last Updated

May 27, 2026

Record last verified: 2026-05

Locations

CN(1)