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

Universitair Ziekenhuis Brussel

Status: Unknown

Conditions: Fertility Disorders; Thyroid Dysfunction

Treatments: Other: follow up treatment outcome; Diagnostic Test: blood test

Study type: Interventional

Funder types: Other

Identifiers

NCT04019509

TgABstudy Brussels

Details and patient eligibility

About

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. Compare pregnancy outcome between women with and without thyroid antibodies

Full 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:

1. To monitor the course of thyroid function during pregnancy and to compare between women with and without thyroid autoantibodies.
2. Compare pregnancy outcome between women with and without thyroid antibodies

Enrollment: 900 estimated patients

Sex: Female

Ages: 18 to 36 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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900 participants in 3 patient groups

Tg AB positive, TPO AB negative

Active Comparator group

Description:

Includes patients with only anti-thyroglobuline autoantibodies present and no anti-thyreoperoxydase antibodies at start of fertility treatment.

Treatment:

Other: follow up treatment outcome

Diagnostic Test: blood test

Tg AB negative, TPO AB negative

Active Comparator group

Description:

Includes patients without thyroid autoantibodies at start of fertility treatment

Treatment:

Other: follow up treatment outcome

Diagnostic Test: blood test

Tg AB positive, TPO AB positive

Active Comparator group

Description:

Includes patients with anti-thyroglobuline autoantibodies and anti-thyreoperoxydase antibodies at start of fertility treatment.

Treatment:

Other: follow up treatment outcome

Diagnostic Test: blood test