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PregnancyNCT03932851

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

An observational study of Pregnancy, run by Beijing Ditan Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy
What is being tested?
IVF-ET
Type of treatment
Vaccines
How many people
400 participants
Where
1 siteChina
Study dates
1 Aug 2018to 1 May 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

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.

Who may be able to join

  • pregnant women who have been IVF-operated
  • HBV-infected pregnant women need to be positive for HBsAg for more than half a year.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Wei Yi, doctor contact

+86-13683687062

yiwei1215@163.com

China1 site, 1 recruiting
  • Pregnant women

    Beijing, Beijing Municipality, 100015

    Wei Yi, doctor, +86-1383687062, yiwei1215@163.com

    Recruiting

Other trials in China

About this study

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.

Read the 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.

Conditions
Pregnancy
Being tested
IVF-ET

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IVF-ETOther

    HBV-infected pregnant women and non-HBV-infected pregnant women underwent IVF operation

Study groups in NCT03932851
Study groupRoleWhat they receive
HBsAg(+) pregnant womanData 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.
Receives: Other: IVF-ET
HBsAg(-) pregnant womanData 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).
Receives: Other: IVF-ET

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maternal and infant block failure rate in newborns

    Maternal and infant block failure rate in newborns

    Measured: up to 28 weeks

Secondary outcomes (3)
  1. The length of the newborn and the incidence of various complications during pregnancy.

    The length, weight, Apgar score of the newborn and the incidence of various complications during pregnancy.

    Measured: up to 28 weeks

  2. The weight of the newborn and the incidence of various complications during pregnancy.

    The weight of the newborn and the incidence of various complications during pregnancy.

    Measured: up to 28 weeks

  3. The Apgar score of the newborn and the incidence of various complications during pregnancy.

    The Apgar score of the newborn and the incidence of various complications during pregnancy.

    Measured: up to 28 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2019
  2. Study start1 Aug 2018
  3. Primary completion1 May 2019 (estimated)
  4. Study completion1 May 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03932851
Sponsor's protocol ID
KY2018-012
Status last verified
Apr 2019
First submitted
15 Apr 2019
Last updated
1 May 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Pregnancy, run by Beijing Ditan Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Wei Yi, doctor (+86-13683687062, yiwei1215@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maternal and infant block failure rate in newborns (time frame: up to 28 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2019.

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