The Influence of Different Thyroid Autoantibodies on Thyroid Function and Pregnancy Outcome After Assisted Reproductive Technology

Study Overview
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Brief Summary
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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
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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

Official Title
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The Influence of Different Thyroid Autoantibodies on Thyroid Function and Pregnancy Outcome After Assisted Reproductive Technology

Conditions
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Fertility Disorders, Thyroid Dysfunction

Intervention / Treatment
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* Diagnostic Test: blood test
* Other: follow up treatment outcome


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 36 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tg AB positive, TPO AB negative<br>Includes patients with only anti-thyroglobuline autoantibodies present and no anti-thyreoperoxydase antibodies at start of fertility treatment. | Diagnostic Test: blood test<br>* blood test for thyroid antibodies and thyroid function (TSH, FT4)<br>Other: follow up treatment outcome<br>* questionnaire for treatment outcome: pregnancy, no pregnancy, miscarriage, delivery<br>|
| Active Comparator: Tg AB negative, TPO AB negative<br>Includes patients without thyroid autoantibodies at start of fertility treatment | Diagnostic Test: blood test<br>* blood test for thyroid antibodies and thyroid function (TSH, FT4)<br>Other: follow up treatment outcome<br>* questionnaire for treatment outcome: pregnancy, no pregnancy, miscarriage, delivery<br>|
| Active Comparator: Tg AB positive, TPO AB positive<br>Includes patients with anti-thyroglobuline autoantibodies and anti-thyreoperoxydase antibodies at start of fertility treatment. | Diagnostic Test: blood test<br>* blood test for thyroid antibodies and thyroid function (TSH, FT4)<br>Other: follow up treatment outcome<br>* questionnaire for treatment outcome: pregnancy, no pregnancy, miscarriage, delivery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| thyroid fonction | TSH, FT4 evolution during pregnancy | 12 months | 
| cumulative delivery rate | live birth delivery after IVF stimulation | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cumulative pregnancy rate | pregnancy rate after IVF stimulation | 12 months | 
| miscarriage rate | miscarriage rate after IVF stimulation | 12 months |