Antithyroidal Antibodies With or Without Subclinical Hypothyroidism During Pregnancy in Infertile Women

NCT04249271 | Completed

• 1 other identifier: EKNZ 39-009 00960
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Thyroid Gland Disease; Pregnancy Complications

Keywords

thyroid; antibody; pregnancy; infertility

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (6)

euthyroid, no antibodies

TSH 0.3 to 2.5 mIU/l and anti-TPO \<100 IU/ml repeated serum sampling

Other: serum sampling

borderline euthyroid, no antibodies

TSH 2.5 to 4.5 mIU/l and anti-TPO \<100 IU/l repeated serum sampling

Other: serum sampling

hypothyroidism, no antibodies

TSH \>4.5 mIU/l and anti-TPO \<100 IU/ml repeated serum sampling

Other: serum sampling

euthyroid, with antibodies

TSH 0.3 to 2.5 mIU/l and anti-TPO \>100 IU/ml repeated serum sampling

Other: serum sampling

borderline euthyroid, with antibodies

TSH 2.5 to 4.5 mIU/l and anti-TPO \>100 IU/l repeated serum sampling

Other: serum sampling

hypothyroidism, with antibodiesal

TSH \>4.5 mIU/l and anti-TPO \>100 IU/ml repeated serum sampling

Other: serum sampling

Interventions

serum sampling OTHER

repeated serum sampling during pregnancy and thereafter

borderline euthyroid, no antibodies; borderline euthyroid, with antibodies; euthyroid, no antibodies; euthyroid, with antibodies; hypothyroidism, no antibodies; hypothyroidism, with antibodiesal

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Pregnancy after infertility
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy women having become pregnancy after infertility.

You may qualify if:

• previous infertility with known thyroidal function (TSH, anti-TPO)

You may not qualify if:

• other endocrine pathology, such as Addison, diabetes mellitus
• manifest thyroidal pathology, such as Graves disease
• contraindication against pregnancy
• after repeated miscarriage (3 or more)
• heavy smokers (20 cig per day or more)

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Klinik für Gyn. Endokrinologie und Reproduktionsmedizin der Frauenklinik des Universitätsspitals

Basel, 4031, Switzerland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples

MeSH Terms

Conditions

Thyroid Diseases; Pregnancy Complications; Infertility

Condition Hierarchy (Ancestors)

Endocrine System Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Christian De Geyter, Prof.

  University of Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: February 17, 2018
• First Posted: January 30, 2020
• Study Start: February 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: January 30, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)