Fertility DisordersTgABNCT04019509
The Influence of Different Thyroid Autoantibodies on Thyroid Function and Pregnancy Outcome After Assisted Reproductive Technology
A study testing blood test and follow up treatment outcome in people with Fertility Disorders and Thyroid Dysfunction, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
The influence of thyroid autoantibodies on thyroid function in pregnancy after fertility treatment is not well known. The objectives of the present study are: 1. To monitor the course of thyroid function during pregnancy and to compare between women with and without thyroid autoantibodies. 2. Read more about this study
- Who is it for?
- Ages 18 to 36 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fertility Disorders, Thyroid Dysfunction
- What is being tested?
- blood test and follow up treatment outcome
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2019to 1 Sep 2022
- Phase
- Interventional
- 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 36 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- first cycle of assisted reproductive technology with follow up of thyroid function at the Universitair Ziekenhuis Brussel
- age >= 18 and <= 36 years
- body mass index between 18 and 35
Who cannot join
- Patients with clinical thyroid dysfunction
- Patients being treated with levothyroxine or antithyroid drugs
- Patients being treated with glucocorticosteroids
- Patients undergoing in vitro maturation or preimplantation genetic testing.
- Poor responders during IVF/ICSI stimulation, using the Bologna criteria
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
UZ Brussel
Brussels, 1090
valerie uvin, md, 486073292 ext. 0032, valerieuvin@hotmail.com
david unuane, md phd, 24774671 ext. 0032, david.unuane@uzbrussel.be
About this study
The influence of thyroid autoantibodies on thyroid function in pregnancy after fertility treatment is not well known.
The objectives of the present study are:
- To monitor the course of thyroid function during pregnancy and to compare between women with and without thyroid autoantibodies.
- Compare pregnancy outcome between women with and without thyroid antibodies
Read the detailed description
Thyroid autoantibodies and / or abnormal thyroid function are associated with fertility problems.
A possible explanation for this is, an influence of thyroid autoantibodies on the functioning of the thyroid gland. It is therefore recommended to check thyroid gland function and for the presence of autoantibodies before pregnancy. In general, 2 types of thyroid autoantibodies are known: anti-thyreoperoxidase autoantibodies and anti-thyroglobulin autoantibodies.
In case of abnormal thyroid function, treatment is sometimes necessary in regards to fertility. The risk of abnormal thyroid function is increased in women with thyroid autoantibodies during pregnancy. Therefore, thyroid function is regularly monitored during pregnancy in women with thyroid antibodies. The influence of thyroid autoantibodies on thyroid function in pregnancy after fertility treatment is not well known.
The objectives of the present study are:
- To monitor the course of thyroid function during pregnancy and to compare between women with and without thyroid autoantibodies.
- Compare pregnancy outcome between women with and without thyroid antibodies
- Conditions
- Fertility Disorders, Thyroid Dysfunction
- Being tested
- blood test, follow up treatment outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood testDiagnostic test
blood test for thyroid antibodies and thyroid function (TSH, FT4)
follow up treatment outcomeOther
questionnaire for treatment outcome: pregnancy, no pregnancy, miscarriage, delivery
| Study group | Role | What they receive |
|---|---|---|
| Tg AB positive, TPO AB negative | Active comparator | Includes patients with only anti-thyroglobuline autoantibodies present and no anti-thyreoperoxydase antibodies at start of fertility treatment. Receives: Diagnostic Test: blood test; Other: follow up treatment outcome |
| Tg AB negative, TPO AB negative | Active comparator | Includes patients without thyroid autoantibodies at start of fertility treatment Receives: Diagnostic Test: blood test; Other: follow up treatment outcome |
| Tg AB positive, TPO AB positive | Active comparator | Includes patients with anti-thyroglobuline autoantibodies and anti-thyreoperoxydase antibodies at start of fertility treatment. Receives: Diagnostic Test: blood test; Other: follow up treatment outcome |
What is being measured
The primary outcome is the main question the study is designed to answer.
thyroid fonction
TSH, FT4 evolution during pregnancy
Measured: 12 months
cumulative delivery rate
live birth delivery after IVF stimulation
Measured: 12 months
Secondary outcomes (2)
cumulative pregnancy rate
pregnancy rate after IVF stimulation
Measured: 12 months
miscarriage rate
miscarriage rate after IVF stimulation
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2019
- Study start1 Jan 2019
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fertility DisordersStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valerie Uvin, Universitair Ziekenhuis Brussel
- Investigators
- valerie uvin, md, Principal investigator, UZ Brussels
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04019509
- Sponsor's protocol ID
- TgABstudy Brussels
- Acronym
- TgAB
- Status last verified
- Jul 2019
- First submitted
- 10 Jul 2019
- Last updated
- 15 Jul 2019
- Results posted
- No
- Data monitoring committee
- 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 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Different Thyroid Autoantibodies on Thyroid Function and Pregnancy Outcome After Assisted Reproductive Technology
- ClinicalTrials.gov ID
- NCT04019509
- Acronym / sponsor ID
- TgAB / TgABstudy Brussels
- Conditions
- Fertility Disorders, Thyroid Dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 15 Jul 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.
The influence of thyroid autoantibodies on thyroid function in pregnancy after fertility treatment is not well known.
The objectives of the present study are:
- To monitor the course of thyroid function during pregnancy and to compare between women with and without thyroid autoantibodies.
- Compare pregnancy outcome between women with and without thyroid antibodies
Detailed description
Thyroid autoantibodies and / or abnormal thyroid function are associated with fertility problems.
A possible explanation for this is, an influence of thyroid autoantibodies on the functioning of the thyroid gland. It is therefore recommended to check thyroid gland function and for the presence of autoantibodies before pregnancy. In general, 2 types of thyroid autoantibodies are known: anti-thyreoperoxidase autoantibodies and anti-thyroglobulin autoantibodies.
In case of abnormal thyroid function, treatment is sometimes necessary in regards to fertility. The risk of abnormal thyroid function is increased in women with thyroid autoantibodies during pregnancy. Therefore, thyroid function is regularly monitored during pregnancy in women with thyroid antibodies. The influence of thyroid autoantibodies on thyroid function in pregnancy after fertility treatment is not well known.
The objectives of the present study are:
- To monitor the course of thyroid function during pregnancy and to compare between women with and without thyroid autoantibodies.
- Compare pregnancy outcome between women with and without thyroid antibodies
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tg AB positive, TPO AB negative | Active comparator | Diagnostic Test: blood test, Other: follow up treatment outcomeIncludes patients with only anti-thyroglobuline autoantibodies present and no anti-thyreoperoxydase antibodies at start of fertility treatment. |
| Tg AB negative, TPO AB negative | Active comparator | Diagnostic Test: blood test, Other: follow up treatment outcomeIncludes patients without thyroid autoantibodies at start of fertility treatment |
| Tg AB positive, TPO AB positive | Active comparator | Diagnostic Test: blood test, Other: follow up treatment outcomeIncludes patients with anti-thyroglobuline autoantibodies and anti-thyreoperoxydase antibodies at start of fertility treatment. |
Who may qualify
- Ages
- 18 to 36 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- first cycle of assisted reproductive technology with follow up of thyroid function at the Universitair Ziekenhuis Brussel
- age >= 18 and <= 36 years
- body mass index between 18 and 35
Key exclusion criteria (5 listed)
- Patients with clinical thyroid dysfunction
- Patients being treated with levothyroxine or antithyroid drugs
- Patients being treated with glucocorticosteroids
- Patients undergoing in vitro maturation or preimplantation genetic testing.
- Poor responders during IVF/ICSI stimulation, using the Bologna criteria
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 |
|---|---|---|
| blood testblood test for thyroid antibodies and thyroid function (TSH, FT4) | Diagnostic test | Tg AB negative, TPO AB negative, Tg AB positive, TPO AB negative, Tg AB positive, TPO AB positive |
| follow up treatment outcomequestionnaire for treatment outcome: pregnancy, no pregnancy, miscarriage, delivery | Other | Tg AB negative, TPO AB negative, Tg AB positive, TPO AB negative, Tg AB positive, TPO AB positive |
Primary outcome
thyroid fonction
Time frame: 12 months
TSH, FT4 evolution during pregnancy
cumulative delivery rate
Time frame: 12 months
live birth delivery after IVF stimulation
2 secondary outcomes
cumulative pregnancy rate
Time frame: 12 months
miscarriage rate
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 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.
valerie uvin, md principal investigator
UZ Brussels
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood test and follow up treatment outcome in people with Fertility Disorders and Thyroid Dysfunction, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 3 inclusion and 5 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 15 Jul 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 Belgium. 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 valerie uvin, md (486073292 ext. 0032, valerieuvin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
thyroid fonction (time frame: 12 months). The study lists 2 primary outcomes in all. 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 15 Jul 2019.