Seroepidemiologic Study of Spermatozoal Transmission of Hepatitis B Virus (HBV)
A Fetal Seroepidemiologic Study in Hepatitis B Virus Transmitted Via Male Germ Line
1 other identifier
observational
407
1 country
1
Brief Summary
Animal experiments demonstrated that father might transmit HBV vertically via male germ line, however, whether it is really existed in human remains to be determined. Since HBV is a blood-borne virus, the unvaccinated pregnant women would be at risk for HBV exposure if their fetuses carried the virus from fathers. If women had been vaccinated for HBV before conception, what would happen to a maternal immune system if her fetus carried HBV from spermatozoa? However, the literature on transmission of HBV by spermatozoa in vivo is rare, the viral replicating status and fetal immune response in uterus are unknown. The aim of study was to detect father-to-fetus transmission of hepatitis B virus (HBV) in uterus.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2008
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 8, 2012
CompletedFirst Posted
Study publicly available on registry
April 10, 2012
CompletedApril 10, 2012
April 1, 2012
2.9 years
April 8, 2012
April 9, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
positive rate of HBV in uterus
HBV infection confirmed by serological makers(HBsAg, HBeAg, anti-HBs, anti-HBe anti-HBc)and HBVDNA. Samples were assessed by enzyme immunoassays and FQ-PCR
one year
Secondary Outcomes (1)
response rate of postnatal vaccination
half a year after immunization series
Study Arms (3)
Only father carrier
fetuses whose fathers were HBV carriers whereas mothers negatively.
only mother carrier
fetuses whose mothers were HBV carriers whereas fathers negatively.
both parents carriers
fetuses whose both parents were HBV carriers
Eligibility Criteria
The research consisted of the pregnant women who visited for prenatal diagnosis during the January 2008 and June 2010.
You may qualify if:
- one or both of pregnant Woman and her husband were HBV carriers
- indicated for amniocentesis or cordocentesis
You may not qualify if:
- indicated for chorionic villous sampling
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- YiYang Zhulead
Study Sites (1)
Taizhou Hospital of Zhejiang Province
Linhai, Zhejiang, 317000, China
Biospecimen
whole blood, serum,amniotic fluid
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yi-Yang Zhu, MD
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Center for Prenatal Diagnosis
Study Record Dates
First Submitted
April 8, 2012
First Posted
April 10, 2012
Study Start
January 1, 2008
Primary Completion
December 1, 2010
Study Completion
December 1, 2011
Last Updated
April 10, 2012
Record last verified: 2012-04