Clinical trial NCT04019509: The Influence of Different Thyroid Autoantibodies on Thyroid Function and Pregnancy Outcome After Assisted Reproductive Technology
Official title: The Influence of Different Thyroid Autoantibodies on Thyroid Function and Pregnancy Outcome After Assisted Reproductive Technology
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fertility Disorders
Thyroid Dysfunction
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2019-07-15
Enrollment: 900
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: DIAGNOSTIC

Brief 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. 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:

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

Eligibility criteria: 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

Primary outcomes:
measure: thyroid fonction
timeFrame: 12 months
measure: cumulative delivery rate
timeFrame: 12 months
Secondary outcomes:
measure: cumulative pregnancy rate
timeFrame: 12 months
measure: miscarriage rate
timeFrame: 12 months
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: UZ Brussel
Study officials:
affiliation: UZ Brussels
name: valerie uvin, md
role: PRINCIPAL_INVESTIGATOR
References: