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.
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.
China1 site, 1 recruiting
- Recruiting
Pregnant women
Beijing, Beijing Municipality, 100015
Wei Yi, doctor, +86-1383687062, yiwei1215@163.com
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: IVF-ET | |
| 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). Receives: Other: IVF-ET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal and infant block failure rate in newborns
Maternal and infant block failure rate in newborns
Measured: up to 28 weeks
Secondary outcomes (3)
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
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
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.
- First posted1 May 2019
- Study start1 Aug 2018
- Primary completion1 May 2019 (estimated)
- Study completion1 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Beijing Ditan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Yi, Beijing Ditan Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Effect of IVF-ET on Mother-to-child Transmission of Hepatitis B Virus
- ClinicalTrials.gov ID
- NCT03932851
- Acronym / sponsor ID
- KY2018-012
- Conditions
- Pregnancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Beijing Ditan HospitalUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 May 2019 (estimated)
- Study completion
- 1 May 2019 (estimated)
- First posted
- 1 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HBsAg(+) pregnant woman | – | Other: IVF-ETData 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. |
| HBsAg(-) pregnant woman | – | Other: IVF-ETData 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). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (2 listed)
- pregnant women who have been IVF-operated
- HBV-infected pregnant women need to be positive for HBsAg for more than half a year.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IVF-ETHBV-infected pregnant women and non-HBV-infected pregnant women underwent IVF operation | Other | HBsAg(+) pregnant woman, HBsAg(-) pregnant woman |
Primary outcome
Maternal and infant block failure rate in newborns
Time frame: up to 28 weeks
Maternal and infant block failure rate in newborns
3 secondary outcomes
The length 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.
Time frame: up to 28 weeks
The Apgar score of the newborn and the incidence of various complications during pregnancy.
Time frame: up to 28 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.