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

Not Applicable

• Conditions: Fertility Disorders; Thyroid Dysfunction
• Interventions: Diagnostic Test: blood test; Other: follow up treatment outcome

• Registration Number: NCT04019509
• Lead Sponsor: Universitair Ziekenhuis Brussel

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

Study Timeline

• Study Start: 2019-01-01
• Status Verified: 2019-07
• Study First Submitted: 2019-07-10
• Study First Submitted QC: 2019-07-10
• Last Update Submitted: 2019-07-10
• Study First Posted: 2019-07-15
• Last Update Posted: 2019-07-15
• Primary Completion: 2022-01-01
• Study Completion: 2022-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 900

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Tg AB positive, TPO AB negative	follow up treatment outcome	Includes patients with only anti-thyroglobuline autoantibodies present and no anti-thyreoperoxydase antibodies at start of fertility treatment.
Tg AB negative, TPO AB negative	follow up treatment outcome	Includes patients without thyroid autoantibodies at start of fertility treatment
Tg AB positive, TPO AB negative	blood test	Includes patients with only anti-thyroglobuline autoantibodies present and no anti-thyreoperoxydase antibodies at start of fertility treatment.
Tg AB positive, TPO AB positive	follow up treatment outcome	Includes patients with anti-thyroglobuline autoantibodies and anti-thyreoperoxydase antibodies at start of fertility treatment.
Tg AB negative, TPO AB negative	blood test	Includes patients without thyroid autoantibodies at start of fertility treatment
Tg AB positive, TPO AB positive	blood test	Includes patients with anti-thyroglobuline autoantibodies and anti-thyreoperoxydase antibodies at start of fertility treatment.

Primary Outcome Measures

Name	Time	Method
thyroid fonction	12 months	TSH, FT4 evolution during pregnancy
cumulative delivery rate	12 months	live birth delivery after IVF stimulation

Secondary Outcome Measures

Name	Time	Method
miscarriage rate	12 months	miscarriage rate after IVF stimulation
cumulative pregnancy rate	12 months	pregnancy rate after IVF stimulation

Trial Locations

Locations (1)

UZ Brussel; 🇧🇪 Brussels, Belgium