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

NCT ID: NCT04019509

Last Updated: 2019-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2022-09-01

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:

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

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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:

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

Conditions

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Fertility Disorders Thyroid Dysfunction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Tg AB positive, TPO AB negative

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

Group Type ACTIVE_COMPARATOR

blood test

Intervention Type DIAGNOSTIC_TEST

blood test for thyroid antibodies and thyroid function (TSH, FT4)

follow up treatment outcome

Intervention Type OTHER

questionnaire for treatment outcome: pregnancy, no pregnancy, miscarriage, delivery

Tg AB negative, TPO AB negative

Includes patients without thyroid autoantibodies at start of fertility treatment

Group Type ACTIVE_COMPARATOR

blood test

Intervention Type DIAGNOSTIC_TEST

blood test for thyroid antibodies and thyroid function (TSH, FT4)

follow up treatment outcome

Intervention Type OTHER

questionnaire for treatment outcome: pregnancy, no pregnancy, miscarriage, delivery

Tg AB positive, TPO AB positive

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

Group Type ACTIVE_COMPARATOR

blood test

Intervention Type DIAGNOSTIC_TEST

blood test for thyroid antibodies and thyroid function (TSH, FT4)

follow up treatment outcome

Intervention Type OTHER

questionnaire for treatment outcome: pregnancy, no pregnancy, miscarriage, delivery

Interventions

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blood test

blood test for thyroid antibodies and thyroid function (TSH, FT4)

Intervention Type DIAGNOSTIC_TEST

follow up treatment outcome

questionnaire for treatment outcome: pregnancy, no pregnancy, miscarriage, delivery

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

36 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

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Valerie Uvin

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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valerie uvin, md

Role: PRINCIPAL_INVESTIGATOR

UZ Brussels

Locations

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UZ Brussel

Brussels, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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valerie uvin, md

Role: CONTACT

486073292 ext. 0032

david unuane, md phd

Role: CONTACT

024774671 ext. 0032

Facility Contacts

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valerie uvin, md

Role: primary

486073292 ext. 0032

david unuane, md phd

Role: backup

24774671 ext. 0032

Other Identifiers

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TgABstudy Brussels

Identifier Type: -

Identifier Source: org_study_id

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