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One prospective observational study was carried out in 2009 aiming at identifying the fluctuations of the thyroid hormones in women with normal thyroid gland and in women with anti-TPO antibodies. Serum samples were collected periodically during and after pregnancy in previously infertile women. The samples were stored frozen at -80 °C. Now, the hormone measurements will be carried out.
Exclusion of thyroid disease has long been an integral part of a comprehensive infertility work-up, because thyroid function disorders are also associated with disturbances in the menstrual cycle and can cause complications during pregnancy. Subclinical hypothyroidism is the most frequent disease of the thyroid in women of reproductive age (affecting 5 to 10 %). For a long time, measurement of TSH concentration was the only screening parameter used to exclude thyroid disorders. Not only has the differentiation of normal thyroid function (euthyroidism) from the pathological range been controversial for some years but, recently, the role of an elevated anti-TPO antibody titre has also been identified as a significant and independent risk factor for miscarriages and for complications during late pregnancy, even in otherwise euthyroid women. This discovery implies that solely determining the TSH concentration is insufficient. The mechanism underlying the increased rate of complications during pregnancy is also unclear.
The investigators therefore performed a double study to clarify the relative importance of the various possible parameters of thyroid function in the context of an infertility work-up:
After conclusion of the observation period, levels of the following hormones will be measured in the total of 1120 serum samples: TSH, total and free l-thyroxine and fT4 index, total and free triiodothyronine, thyroid autoantibodies (TPO antibodies), hCG, 17β-oestradiol, progesterone, prolactin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| euthyroid, no antibodies | TSH 0.3 to 2.5 mIU/l and anti-TPO <100 IU/ml repeated serum sampling |
| |
| borderline euthyroid, no antibodies | TSH 2.5 to 4.5 mIU/l and anti-TPO <100 IU/l repeated serum sampling |
| |
| hypothyroidism, no antibodies | TSH >4.5 mIU/l and anti-TPO <100 IU/ml repeated serum sampling |
| |
| euthyroid, with antibodies | TSH 0.3 to 2.5 mIU/l and anti-TPO >100 IU/ml repeated serum sampling |
| |
| borderline euthyroid, with antibodies | TSH 2.5 to 4.5 mIU/l and anti-TPO >100 IU/l repeated serum sampling |
| |
| hypothyroidism, with antibodiesal | TSH >4.5 mIU/l and anti-TPO >100 IU/ml repeated serum sampling |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| serum sampling | Other | repeated serum sampling during pregnancy and thereafter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Deviations from euthyroid function as given by serum levels of TSH (expressed in mIU/l) during pregnancy and after birth. | Impact of antibodies on thyroid function during pregnancy. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
Pregnancy after infertility
Healthy women having become pregnancy after infertility.
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| Name | Affiliation | Role |
|---|---|---|
| Christian De Geyter, Prof. | University of Basel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik für Gyn. Endokrinologie und Reproduktionsmedizin der Frauenklinik des Universitätsspitals | Basel | 4031 | Switzerland |
The serum samples are coded and cannot be traced back to individual patients.
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| ID | Term |
|---|---|
| D013959 | Thyroid Diseases |
| D011248 | Pregnancy Complications |
| D007246 | Infertility |
| ID | Term |
|---|---|
| D004700 | Endocrine System Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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Serum samples