InfertilityNCT04443283
The Effect of Latent Tuberculosis Infection on the Pregnancy Outcome of IVF-ET
An observational study of Infertility and Tuberculosis, run by Peking University Third Hospital at 1 site in China.
Trial summary
This study evaluate the effect of latent infection of tuberculosis on the pregnancy outcome of IVF-ET in infertile patients with radiographic lesions suggesting old healed tuberculosis Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Infertility, Tuberculosis
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 30 Dec 2022
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants were recruited between January 1, 2019, and December 30, 2020, at Peking University Third Hospital, a tertiary referral hospital in Beijing, China. A board-certified radiologist reviewed CXRs and, if available, chest computed tomography (CT) scans, of women who referred to the reproductive center for IVF-ET. The patients who had chest imaging abnormalities consistent with old healed TB were admitted or referred to the respiratory clinic and enrolled.
Who may be able to join
- The patients who referred to the reproductive center for IVF-ET
- Chest radiography showed old healed tuberculosis
Who cannot join
- active tuberculosis
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
Official title: A Prospective Cohort Study on the Effect of Latent Infection of Tuberculosis on the Pregnancy Outcome of IVF-ET in Infertile Patients With Radiographic Lesions Suggesting Old Healed Tuberculosis
This study evaluate the effect of latent infection of tuberculosis on the pregnancy outcome of IVF-ET in infertile patients with radiographic lesions suggesting old healed tuberculosis
Read the detailed description
China is one of the countries with high burden of tuberculosis (TB) defined by WHO. IVF-ET is an effective method to treat infertility. Chest X-ray is a routine examination before IVF-ET, which can exclude active tuberculosis. However, for patients with chest X-ray showing old healed tuberculosis, the relationship between latent tuberculosis infection (LTBI) and pregnancy outcomes is unknown. In this study, a prospective cohort study was carried out in infertile women who were planning to receive IVF-ET. IGRA were tested in patients with old tuberculosis in chest X-ray. A cohort of IGRA positive and IGRA negative was constructed. The pregnancy outcomes were followed up prospectively and the relationship between latent infection of tuberculosis and pregnancy outcomes was analyzed. The primary outcome was clinical pregnancy rate, miscarriage rate and live birth rate. Secondary outcomes were tuberculosis reactivation during pregnancy period and in 3 months after delivery.
- Conditions
- Infertility, Tuberculosis
- Being tested
- No intervention
- Keywords
- infertility, IVF-ET, old tuberculosis, pregnancy outcome, latent tuberculosis infection
- Medical subject headings
- Infertility, Tuberculosis, Latent Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This is a observation study, with no intervention
| Study group | Role | What they receive |
|---|---|---|
| LTBI Group | IGRA(+) Receives: Other: No intervention | |
| No LTBI Group | IGRA(+) Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical pregnancy rate
Clinical pregnancy was defined as the observation of a gestational sac on ultrasonography. The clinical pregnancy rate was defined as clinical pregnancy per embryo transfer.
Measured: 30 days after the ET procedure
miscarriage rate
Miscarriage was defined as a pregnancy loss before 28 weeks of gestation (calculated among women who became pregnant). The miscarriage rate was defined as miscarriages per clinical pregnancy.
Measured: 40 weeks after the ET procedure
live birth rate
Live birth was defined as delivery of a living foetus (or living foetuses) beyond 28 weeks of gestation. The live birth rate was defined as live birth per embryo transfer.
Measured: 40 weeks after the ET procedure
Secondary outcomes (1)
tuberculosis reactivation
tuberculosis during pregnancy period and in 3 months after delivery
Measured: 40 weeks after the ET procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start1 Jan 2019
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ji Qiao, MD., Principal investigator, Reproductive Medicine Centre，Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04443283
- Sponsor's protocol ID
- PCCMRP
- Status last verified
- Mar 2020
- First submitted
- 21 Jun 2020
- Last updated
- 29 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gai X, Chi H, Zeng L, Cao W, Chen L, Zhang C, Li R, Sun Y, Qiao J. Impact of Positive Interferon-Gamma Release Assay on IVF-ET Pregnancy Outcomes in Infertile Patients With Untreated Prior Tuberculosis: A Prospective Cohort Study. Front Med (Lausanne). 2021 Nov 16;8:749410. doi: 10.3389/fmed.2021.749410. eCollection 2021.
PubMed 34869442
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study on the Effect of Latent Infection of Tuberculosis on the Pregnancy Outcome of IVF-ET in Infertile Patients With Radiographic Lesions Suggesting Old Healed Tuberculosis
- ClinicalTrials.gov ID
- NCT04443283
- Acronym / sponsor ID
- PCCMRP
- Conditions
- Infertility, Tuberculosis
- Keywords
- infertility, IVF-ET, old tuberculosis, pregnancy outcome, latent tuberculosis infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 23 Jun 2020 (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 evaluate the effect of latent infection of tuberculosis on the pregnancy outcome of IVF-ET in infertile patients with radiographic lesions suggesting old healed tuberculosis
Detailed description
China is one of the countries with high burden of tuberculosis (TB) defined by WHO. IVF-ET is an effective method to treat infertility. Chest X-ray is a routine examination before IVF-ET, which can exclude active tuberculosis. However, for patients with chest X-ray showing old healed tuberculosis, the relationship between latent tuberculosis infection (LTBI) and pregnancy outcomes is unknown. In this study, a prospective cohort study was carried out in infertile women who were planning to receive IVF-ET. IGRA were tested in patients with old tuberculosis in chest X-ray. A cohort of IGRA positive and IGRA negative was constructed. The pregnancy outcomes were followed up prospectively and the relationship between latent infection of tuberculosis and pregnancy outcomes was analyzed. The primary outcome was clinical pregnancy rate, miscarriage rate and live birth rate. Secondary outcomes were tuberculosis reactivation during pregnancy period and in 3 months after delivery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LTBI Group | – | Other: No interventionIGRA(+) |
| No LTBI Group | – | Other: No interventionIGRA(+) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants were recruited between January 1, 2019, and December 30, 2020, at Peking University Third Hospital, a tertiary referral hospital in Beijing, China. A board-certified radiologist reviewed CXRs and, if available, chest computed tomography (CT) scans, of women who referred to the reproductive center for IVF-ET. The patients who had chest imaging abnormalities consistent with old healed TB were admitted or referred to the respiratory clinic and enrolled.
Key inclusion criteria (2 listed)
- The patients who referred to the reproductive center for IVF-ET
- Chest radiography showed old healed tuberculosis
Key exclusion criteria (1 listed)
- active tuberculosis
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 |
|---|---|---|
| No interventionThis is a observation study, with no intervention | Other | LTBI Group, No LTBI Group |
Primary outcome
clinical pregnancy rate
Time frame: 30 days after the ET procedure
Clinical pregnancy was defined as the observation of a gestational sac on ultrasonography. The clinical pregnancy rate was defined as clinical pregnancy per embryo transfer.
miscarriage rate
Time frame: 40 weeks after the ET procedure
Miscarriage was defined as a pregnancy loss before 28 weeks of gestation (calculated among women who became pregnant). The miscarriage rate was defined as miscarriages per clinical pregnancy.
live birth rate
Time frame: 40 weeks after the ET procedure
Live birth was defined as delivery of a living foetus (or living foetuses) beyond 28 weeks of gestation. The live birth rate was defined as live birth per embryo transfer.
1 secondary outcome
tuberculosis reactivation
Time frame: 40 weeks after the ET procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2020.
- Derived from this study: PubMed 34869442Gai X, Chi H, Zeng L, Cao W, Chen L, Zhang C, Li R, Sun Y, Qiao J. Impact of Positive Interferon-Gamma Release Assay on IVF-ET Pregnancy Outcomes in Infertile Patients With Untreated Prior Tuberculosis: A Prospective Cohort Study. Front Med (Lausanne). 2021 Nov 16;8:749410. doi: 10.3389/fmed.2021.749410. eCollection 2021.
- Individual participant dataSharing planned: No
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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.
Ji Qiao, MD. principal investigator
Reproductive Medicine Centre，Peking University Third Hospital
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 Infertility and Tuberculosis, run by Peking University Third 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 1 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 29 Jun 2020. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical pregnancy rate (time frame: 30 days after the ET procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04443283, which also lists 1 linked publication.
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 29 Jun 2020.