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

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 Overview

• Status: Unknown
• Conditions: Fertility Disorders; Thyroid Dysfunction
• Intervention / Treatment: Diagnostic test: blood test; Other: follow up treatment outcome

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 Type: Interventional
• Enrollment (Anticipated): 900
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1090
    • Recruiting
    • UZ Brussel
    • Contact: valerie uvin, md; Phone Number: 0032 486073292; Email: valerieuvin@hotmail.com
    • Contact: david unuane, md phd; Phone Number: 0032 24774671; Email: david.unuane@uzbrussel.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 36 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tg AB positive, TPO AB negative; Includes patients with only anti-thyroglobuline autoantibodies present and no anti-thyreoperoxydase antibodies at start of fertility treatment.	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
Active Comparator: Tg AB negative, TPO AB negative; Includes patients without thyroid autoantibodies at start of fertility treatment	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
Active Comparator: Tg AB positive, TPO AB positive; Includes patients with anti-thyroglobuline autoantibodies and anti-thyreoperoxydase antibodies at start of fertility treatment.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
thyroid fonction	TSH, FT4 evolution during pregnancy	12 months
cumulative delivery rate	live birth delivery after IVF stimulation	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cumulative pregnancy rate	pregnancy rate after IVF stimulation	12 months
miscarriage rate	miscarriage rate after IVF stimulation	12 months

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel
• Investigators: Principal Investigator: valerie uvin, md, UZ Brussels

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: July 10, 2019
• First Submitted That Met QC Criteria: July 10, 2019
• First Posted (Actual): July 15, 2019

Study Record Updates

• Last Update Posted (Actual): July 15, 2019
• Last Update Submitted That Met QC Criteria: July 10, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases
• Other Study ID Numbers: TgABstudy Brussels

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No