NCT04019509

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. 1.To monitor the course of thyroid function during pregnancy and to compare between women with and without thyroid autoantibodies.
  2. 2.Compare pregnancy outcome between women with and without thyroid antibodies

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
900

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 15, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

July 15, 2019

Status Verified

July 1, 2019

Enrollment Period

3 years

First QC Date

July 10, 2019

Last Update Submit

July 10, 2019

Conditions

Fertility DisordersThyroid Dysfunction

Outcome Measures

Primary Outcomes (2)

  • thyroid fonction

    TSH, FT4 evolution during pregnancy

    12 months

  • cumulative delivery rate

    live birth delivery after IVF stimulation

    12 months

Secondary Outcomes (2)

  • cumulative pregnancy rate

    12 months

  • miscarriage rate

    12 months

Study Arms (3)

Tg AB positive, TPO AB negative

ACTIVE COMPARATOR

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

Diagnostic Test: blood testOther: follow up treatment outcome

Tg AB negative, TPO AB negative

ACTIVE COMPARATOR

Includes patients without thyroid autoantibodies at start of fertility treatment

Diagnostic Test: blood testOther: follow up treatment outcome

Tg AB positive, TPO AB positive

ACTIVE COMPARATOR

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

Diagnostic Test: blood testOther: follow up treatment outcome

Interventions

blood testDIAGNOSTIC_TEST

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

Tg AB negative, TPO AB negativeTg AB positive, TPO AB negativeTg AB positive, TPO AB positive
follow up treatment outcomeOTHER

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

Tg AB negative, TPO AB negativeTg AB positive, TPO AB negativeTg AB positive, TPO AB positive

Eligibility Criteria

Age18 Years - 36 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Brussel

Brussels, 1090, Belgium

RECRUITING

MeSH Terms

Interventions

Hematologic Tests

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • valerie uvin, md

    UZ Brussels

    PRINCIPAL INVESTIGATOR

Central Study Contacts

valerie uvin, md

CONTACT

486073292valerieuvin@hotmail.com

david unuane, md phd

CONTACT

024774671david.unuane@uzbrussel.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 10, 2019

First Posted

July 15, 2019

Study Start

January 1, 2019

Primary Completion

January 1, 2022

Study Completion

September 1, 2022

Last Updated

July 15, 2019

Record last verified: 2019-07

Locations

BE(1)