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临床试验/NCT04019509
NCT04019509Unknown不适用

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

Universitair Ziekenhuis Brussel2 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2019年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
900
试验地点
2
主要终点
thyroid fonction

研究概览

简要总结

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

详细描述

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

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Factorial
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 36 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Tg AB negative, TPO AB negative

Active Comparator

Includes patients without thyroid autoantibodies at start of fertility treatment

干预措施: blood test (Diagnostic Test)

Tg AB negative, TPO AB negative

Active Comparator

Includes patients without thyroid autoantibodies at start of fertility treatment

干预措施: follow up treatment outcome (Other)

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.

干预措施: follow up treatment outcome (Other)

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.

干预措施: blood test (Diagnostic Test)

Tg AB positive, TPO AB positive

Active Comparator

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

干预措施: blood test (Diagnostic Test)

Tg AB positive, TPO AB positive

Active Comparator

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

干预措施: follow up treatment outcome (Other)

结局指标

主要结局

thyroid fonction

时间窗: 12 months

TSH, FT4 evolution during pregnancy

cumulative delivery rate

时间窗: 12 months

live birth delivery after IVF stimulation

次要结局

  • miscarriage rate(12 months)
  • cumulative pregnancy rate(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Valerie Uvin

MD

Universitair Ziekenhuis Brussel

研究点 (2)

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