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

Fertility Disorders Clinical Trial

— TgAB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04019509
• Other study ID #: TgABstudy Brussels
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: September 1, 2022

Study information

• Verified date: July 2019
• Source: Universitair Ziekenhuis Brussel
• Contact: valerie uvin, md
• Phone: 486073292
• Email: valerieuvin[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Compare pregnancy outcome between women with and without thyroid antibodies

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: September 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 36 Years

Eligibility

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

Related Conditions & MeSH terms

• Fertility Disorders
• Thyroid Diseases
• Thyroid Dysfunction

Intervention

Diagnostic Test:
• blood test
blood test for thyroid antibodies and thyroid function (TSH, FT4)

Other:
• follow up treatment outcome
questionnaire for treatment outcome: pregnancy, no pregnancy, miscarriage, delivery

Locations

Country	Name	City	State
Belgium	UZ Brussel	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	thyroid fonction	TSH, FT4 evolution during pregnancy	12 months
Primary	cumulative delivery rate	live birth delivery after IVF stimulation	12 months
Secondary	cumulative pregnancy rate	pregnancy rate after IVF stimulation	12 months
Secondary	miscarriage rate	miscarriage rate after IVF stimulation	12 months