Back to resultsThe Influence of Different Thyroid Autoantibodies on Thyroid Function and Pregnancy Outcome After Assisted Reproductive Technology (TgAB)
Primary Purpose
Fertility Disorders, Thyroid Dysfunction
Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
blood test
follow up treatment outcome
Sponsored by
About this trial
This is an interventional diagnostic trial for Fertility Disorders
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
Sites / Locations
- UZ BrusselRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Tg AB positive, TPO AB negative
Tg AB negative, TPO AB negative
Tg AB positive, TPO AB positive
Arm Description
Includes patients with only anti-thyroglobuline autoantibodies present and no anti-thyreoperoxydase antibodies at start of fertility treatment.
Includes patients without thyroid autoantibodies at start of fertility treatment
Includes patients with anti-thyroglobuline autoantibodies and anti-thyreoperoxydase antibodies at start of fertility treatment.
Outcomes
Primary Outcome Measures
thyroid fonction
TSH, FT4 evolution during pregnancy
cumulative delivery rate
live birth delivery after IVF stimulation
Secondary Outcome Measures
cumulative pregnancy rate
pregnancy rate after IVF stimulation
miscarriage rate
miscarriage rate after IVF stimulation
Full Information
NCT ID
NCT04019509
First Posted
July 10, 2019
Last Updated
July 10, 2019
Sponsor
Universitair Ziekenhuis Brussel
1. Study Identification
Unique Protocol Identification Number
NCT04019509
Brief Title
The Influence of Different Thyroid Autoantibodies on Thyroid Function and Pregnancy Outcome After Assisted Reproductive Technology
Acronym
TgAB
Official Title
The Influence of Different Thyroid Autoantibodies on Thyroid Function and Pregnancy Outcome After Assisted Reproductive Technology
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
January 1, 2022 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitair Ziekenhuis Brussel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
To monitor the course of thyroid function during pregnancy and to compare between women with and without thyroid autoantibodies.
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:
To monitor the course of thyroid function during pregnancy and to compare between women with and without thyroid autoantibodies.
Compare pregnancy outcome between women with and without thyroid antibodies
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fertility Disorders, Thyroid Dysfunction
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
900 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tg AB positive, TPO AB negative
Arm Type
Active Comparator
Arm Description
Includes patients with only anti-thyroglobuline autoantibodies present and no anti-thyreoperoxydase antibodies at start of fertility treatment.
Arm Title
Tg AB negative, TPO AB negative
Arm Type
Active Comparator
Arm Description
Includes patients without thyroid autoantibodies at start of fertility treatment
Arm Title
Tg AB positive, TPO AB positive
Arm Type
Active Comparator
Arm Description
Includes patients with anti-thyroglobuline autoantibodies and anti-thyreoperoxydase antibodies at start of fertility treatment.
Intervention Type
Diagnostic Test
Intervention Name(s)
blood test
Intervention Description
blood test for thyroid antibodies and thyroid function (TSH, FT4)
Intervention Type
Other
Intervention Name(s)
follow up treatment outcome
Intervention Description
questionnaire for treatment outcome: pregnancy, no pregnancy, miscarriage, delivery
Primary Outcome Measure Information:
Title
thyroid fonction
Description
TSH, FT4 evolution during pregnancy
Time Frame
12 months
Title
cumulative delivery rate
Description
live birth delivery after IVF stimulation
Time Frame
12 months
Secondary Outcome Measure Information:
Title
cumulative pregnancy rate
Description
pregnancy rate after IVF stimulation
Time Frame
12 months
Title
miscarriage rate
Description
miscarriage rate after IVF stimulation
Time Frame
12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
36 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
valerie uvin, md
Phone
486073292
Ext
0032
Email
valerieuvin@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
david unuane, md phd
Phone
024774671
Ext
0032
Email
david.unuane@uzbrussel.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
valerie uvin, md
Organizational Affiliation
UZ Brussels
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZ Brussel
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
valerie uvin, md
Phone
486073292
Ext
0032
Email
valerieuvin@hotmail.com
First Name & Middle Initial & Last Name & Degree
david unuane, md phd
Phone
24774671
Ext
0032
Email
david.unuane@uzbrussel.be
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Influence of Different Thyroid Autoantibodies on Thyroid Function and Pregnancy Outcome After Assisted Reproductive Technology
We'll reach out to this number within 24 hrs