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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

Clinical Study on the Effect of IVF-ET on Mother-to-child Transmission of Hepatitis B Virus

Clinicaltrials.gov identifier NCT03932851

Recruitment Status Recruiting

First Posted May 1, 2019

Last update posted May 1, 2019

Study Description

Brief summary:

This study is intended to retrospectively collect HBV-infected pregnant women and non-HBV-infected pregnant women who have been born in IVF in the investigators' hospital, collect pregnant women's data during pregnancy, newborn birth data, and hepatitis B virus in July after birth of newborns born to HBV-infected pregnant women. Infection, explore the impact of HBV infection on IVF outcomes and whether IVF operations increase the risk of mother-to-child transmission of HBV.

  • Condition or Disease:Pregnancy
  • Intervention/Treatment: Other: IVF-ET
  • Phase: N/A
Detailed Description

This study is a retrospective study that only retrospectively collects a variety of patient data and does not perform any treatment or examination on the patient. The research design is as follows: 1. All patients with HBV-infected pregnant women and non-HBV-infected pregnant women who had undergone IVF operation were retrospectively collected from the investigators' hospital HIS system. 2.Collecting pregnant women's data from the HIS system (including age, maternal history, liver function during pregnancy, HBV DNA in early pregnancy and before delivery, complication and complications during pregnancy, antiviral use before and during pregnancy, father HBV infection Status), neonatal birth data (including body length, weight, Apgar score, feeding status, hepatitis B vaccination, hepatitis B immunoglobulin use, HBsAg at birth and 7 months after birth, HBV DNA). 3. Statistical analysis: (1) Compare the body length, body weight, Apgar score of newborns born to pregnant women with HBV infection and non-HBV infection, and understand the effect of HBV infection on IVF outcomes. (2) Newborns born to HBV-infected pregnant women were divided into HBV DNA-negative group, low-viral group, and high-viral group according to HBV DNA status. The HBV infection status of these newborns was counted in July, and the different viral loads were tested. The impact on mother-to-child transmission of HBV. (3) When discussing whether IVF operation increases the rate of mother-to-child transmission of HBV, it is more scientific and persuasive to use HBV-infected pregnant women who have not been operated with IVF, but the incidence of twins in IVF is significantly higher than that of natural pregnancy. Further lead to premature birth, postpartum hemorrhage, cesarean section rate, etc., the weight and length of newborns are also affected, so it is difficult to match the appropriate population, so this study decided to HBV infection rate of different HBV DNA load IVF Compared with the literature, the corresponding viral load of HBV infection was compared with the rate of mother-to-child transmission of IVF pregnant women.

Study Design
  • Study Type: Observational
  • Estimated Enrollment: 400 participants
  • Observational Model: Cohort
  • Time Perspective: Retrospective
  • Official Title: Clinical Study on the Effect of IVF-ET on Mother-to-child Transmission of Hepatitis B Virus
  • Actual Study Start Date: August 2018
  • Estimated Primary Completion Date: May 2019
  • Estimated Study Completion Date: May 2019
Groups and Cohorts
Groups/Cohorts Intervention/treatment
: HBsAg(+) pregnant woman
Data from pregnant women during pregnancy (including age, maternal history, liver function during pregnancy, HBV DNA in early pregnancy and before delivery, comorbidities and complications during pregnancy, antiviral use before and during pregnancy, and HBV infection status in fathers) Newborn birth data (including body length, weight, Apgar score, feeding status, hepatitis B vaccination, hepatitis B immunoglobulin use, HBsAg at birth and 7 months after birth, HBV DNA). The newborns born to HBV-infected pregnant women were divided into HBV DNA-negative group, low-viral group, and high-viral group according to HBV DNA status. The HBV infection status of these newborns was counted in July, and the different viral loads were tested. The impact of HBV mother-to-child transmission.
Other: IVF-ET
HBV-infected pregnant women and non-HBV-infected pregnant women underwent IVF operation
: HBsAg(-) pregnant woman
Data from pregnant women during pregnancy (including age, maternal history, liver function during pregnancy, HBV DNA in early pregnancy and before delivery, comorbidities and complications during pregnancy, antiviral use before and during pregnancy, and HBV infection status in fathers) Newborn birth data (including body length, weight, Apgar score, feeding status, hepatitis B vaccination, hepatitis B immunoglobulin use, HBsAg at birth and 7 months after birth, HBV DNA).
Other: IVF-ET
HBV-infected pregnant women and non-HBV-infected pregnant women underwent IVF operation
Outcome Measures
  • Primary Outcome Measures: 1. Maternal and infant block failure rate in newborns [ Time Frame: up to 28 weeks ]
    Maternal and infant block failure rate in newborns
  • Secondary Outcome Measures: 1. The weight of the newborn and the incidence of various complications during pregnancy. [ Time Frame: up to 28 weeks ]
    The weight of the newborn and the incidence of various complications during pregnancy.
  • 2. The length of the newborn and the incidence of various complications during pregnancy. [ Time Frame: up to 28 weeks ]
    The length, weight, Apgar score of the newborn and the incidence of various complications during pregnancy.
  • 3. The Apgar score of the newborn and the incidence of various complications during pregnancy. [ Time Frame: up to 28 weeks ]
    The Apgar score of the newborn and the incidence of various complications during pregnancy.
Eligibility Criteria
  • Ages Eligible for Study: 18 to 35 Years (Adult)
  • Sexes Eligible for Study: Female
  • Accepts Healthy Volunteers: Yes
  • Sampling Method: Probability Sample
  • Study Population: All HBV-infected pregnant women who have been IVF-operated and non-HBV-infected pregnant women, HBV-infected pregnant women need to be positive for HBsAg for more than half a year.
Criteria

Inclusion Criteria:

- pregnant women who have been IVF-operated

- HBV-infected pregnant women need to be positive for HBsAg for more than half a year.

Exclusion Criteria:

- Combined with pregnancy-induced hypertension, premature rupture of membranes, prenatal
bleeding and other diseases;

- history of amniocentesis during pregnancy;

- combined with other viral infections: such as HCV, HIV, CMV.

Contacts and Locations
Contacts

Contact: Wei Yi, doctor +86-13683687062 yiwei1215@163.com

Locations

China, Beijing
Pregnant women
Beijing

Sponsors and Collaborators

Beijing Ditan Hospital

More Information
  • Responsible Party: Beijing Ditan Hospital
  • ClinicalTrials.gov Identifier: NCT03932851 History of Changes
  • Other Study ID Numbers: KY2018-012
  • First Posted: May 1, 2019 Key Record Dates
  • Last Update Posted: May 1, 2019
  • Last Verified: April 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Undecided
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Hepatitis B