Autoimmune ThyroiditisNCT05680376
Thyroid Hormone Values and Anti-thyroid Peroxidase Antibody Positivity in Recurrent Pregnancy Loss
An observational study of Autoimmune Thyroiditis and Recurrent Miscarriage, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the thyroid hormone values and anti-thyroid peroxidase (anti-TPO) levels of women with a diagnosis of recurrent pregnancy loss (RPL) and healthy pregnancies. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Autoimmune Thyroiditis, Recurrent Miscarriage
- How many people
- 103 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 1 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: The study was carried out with a total of 103 patients by retrospectively examining the patients who applied to the Gynecology and Obstetrics Clinic of Bülent Ecevit University Faculty of Medicine between 2018-2022
Who may be able to join
- women with 2 or more pregnancy loses
- for controls women with least one healthy baby
Who cannot join
- any other metabolic disease
- women with one miscarriage
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zonguldak Bulent Ecevit University Faculty of Medicine
Zonguldak
About this study
Official title: Relationship Between Habitual Abortion With Thyroid Hormone Values and Anti-TPO (Anti-thyroid Peroxidase Antibody) Positivity
The aim of this study is to compare the thyroid hormone values and anti-thyroid peroxidase (anti-TPO) levels of women with a diagnosis of recurrent pregnancy loss (RPL) and healthy pregnancies. The primary objective is to find out the relationship between recurrent pregnancy loss with thyroid hormone levels and anti-TPO positivity.
- Conditions
- Autoimmune Thyroiditis, Recurrent Miscarriage
- Keywords
- Thyroid Hormones, Anti Thyroid Peroxidase Antibody, Recurrent pregnancy loss
- Medical subject headings
- Thyroiditis, Autoimmune, Abortion, Habitual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Recurrent Pregnancy loss | patients with a diagnosis of recurrent miscarriage | |
| Healthy Controls | healthy women at same age and similar demographics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-thyroid Peroxidase Antibodies
presence of Anti-thyroid Peroxidase Antibodies in both groups
Measured: 4 years
Thyroid Hormone Levels
levels of Thyroid stimulant Hormone, Thyroxin and triiodothyronine levels
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start1 Jan 2018
- Primary completion1 Oct 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune ThyroiditisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zonguldak Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Büşra Özgen Çeviker, Zonguldak Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05680376
- Sponsor's protocol ID
- 2022/17
- Status last verified
- Dec 2022
- First submitted
- 30 Nov 2022
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Habitual Abortion With Thyroid Hormone Values and Anti-TPO (Anti-thyroid Peroxidase Antibody) Positivity
- ClinicalTrials.gov ID
- NCT05680376
- Acronym / sponsor ID
- 2022/17
- Conditions
- Autoimmune Thyroiditis, Recurrent Miscarriage
- Keywords
- Thyroid Hormones, Anti Thyroid Peroxidase Antibody, Recurrent pregnancy loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Zonguldak Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 11 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to compare the thyroid hormone values and anti-thyroid peroxidase (anti-TPO) levels of women with a diagnosis of recurrent pregnancy loss (RPL) and healthy pregnancies. The primary objective is to find out the relationship between recurrent pregnancy loss with thyroid hormone levels and anti-TPO positivity.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recurrent Pregnancy loss | – | –patients with a diagnosis of recurrent miscarriage |
| Healthy Controls | – | –healthy women at same age and similar demographics |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study was carried out with a total of 103 patients by retrospectively examining the patients who applied to the Gynecology and Obstetrics Clinic of Bülent Ecevit University Faculty of Medicine between 2018-2022
Key inclusion criteria (2 listed)
- women with 2 or more pregnancy loses
- for controls women with least one healthy baby
Key exclusion criteria (2 listed)
- any other metabolic disease
- women with one miscarriage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Anti-thyroid Peroxidase Antibodies
Time frame: 4 years
presence of Anti-thyroid Peroxidase Antibodies in both groups
Thyroid Hormone Levels
Time frame: 4 years
levels of Thyroid stimulant Hormone, Thyroxin and triiodothyronine levels
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmune Thyroiditis and Recurrent Miscarriage, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-thyroid Peroxidase Antibodies (time frame: 4 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2023.