- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05446012
Relationship Between Ectopic Pregnancy and Thyroid Disorders
December 5, 2022 updated by: Serif Aksin, Siirt University
Ectopic Pregnancy and Thyroid Disorders
Fallopian tubes participate in the incorporation of gametes and embryos into the endometrial cavity.
It also provides an optimal environment for flattening and early embryonic development.
Tubal pathologies can cause both primary and secondary infertility.
This condition has been associated with overt and subclinical hypothyroidism.
However, the effects of hypothyroidism on tubal activity are not fully known.
Although a few animal experiment studies on this subject have been published, there is no study on this subject in the literature.
Demonstrating that epithelial and smooth muscle cells of rat fallopian tubes express thyroid receptors in animal experiments showed that fallopian tubes are targets for thyroid hormones.
Again, in an animal experiment study, it was revealed that thyroid hormones have an important control on glycogen and lipid storage, lipid signaling and lymphocyte infiltration, which have an important role in maintaining the microenvironment in the rat fallopian tubes.
This microenvironment is necessary for fertilization, sperm capacitation and gamete development.
In another animal experimental study, it was thought that changes in the size of the epithelium of the fallopian tubes and cell metabolism in hypothyroid rabbits may affect oviductal activity and reproductive functions.
An ectopic pregnancy is defined as a pregnancy implanted outside of the uterus.
Ectopic pregnancy >98% implants in the fallopian tube.
The etiology of ectopic pregnancy is unclear, but tubal implantation is probably due to impaired embryo-tubal transport.
This is due to changes in the tubal environment.
Based on this information, we aim to determine the possible relationship between hypothyroidism and ectopic pregnancy in humans in our study.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Our aim in this study is to determine the possible relationship between hypothyroidism and ectopic pregnancy in humans.
For this purpose, 40 patients with a diagnosis of ectopic pregnancy and 40 patients with diagnosis of early pregnancy followed in Siirt Training and Research Hospital between 30 June 2022 and 30 October 2022 will be included in the study.
The patient's age, pregnancy history, medical history and laboratory findings (TSH, sT3, sT4, TT3, TT4, thryoglobulin , Anti-Peroxidase Antibody, Anti-thryoglobulin Antibody, TSH receptors antibody ) will be recorded.
In the light of the information gathered, it will be tried to determine whether there is a relationship between thyroid dysfunctions and ectopic pregnancy.
Study Type
Observational
Enrollment (Actual)
62
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Siirt, Turkey, 56000
- Siirt Üniversity Medical Faculty
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
women over 18 years of age diagnosed with ectopic pregnancy or early pregnancy
Description
Inclusion Criteria:
- >18 years of age
- Having an early pregnancy or ectopic pregnancy
Exclusion Criteria:
- using medications due to thyroid gland dysfunction
- history of ectopic pregnancy
- history of tubal surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
women diagnosed with ectopic pregnancy (n: 40)
thyroid function tests (TSH, sT3, sT4, TT3, TT4, thryoglobulin, Anti-Peroxidase Antibody, Anti- thryoglobulin Antibody, TSH receptors antibody levels) will be done in women diagnosed with ectopic pregnancy
|
blood sample for thyroid function tests (TSH,T3,T3,Anti peroxidase antibody, anti thyroglobulin antibody)
|
Control group pregnants (n:40)
thyroid function tests (TSH, sT3, sT4, TT3, TT4, thryoglobulin, Anti-Peroxidase Antibody, Anti- thryoglobulin Antibody, TSH receptors antibody levels) will be done in pregnant women in early pregnancy week.
|
blood sample for thyroid function tests (TSH,T3,T3,Anti peroxidase antibody, anti thyroglobulin antibody)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Thyroid dysfunction and ectopic pregnancy
Time Frame: Through study completion, an average of 5 months
|
TSH, T3, T4, TT3, TT4, Thyroglobulin, Anti peroxidase antibody, Anti thyroglobulin antibody,TSH receptors antibody will be measured in patients diagnosed with ectopic pregnancy
|
Through study completion, an average of 5 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Şerif Aksin, Siirt University Medical Faculty Obstetrics and Gynecology Departmant
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Mendez-Tepepa M, Zepeda-Perez D, Espindola-Lozano M, Rodriguez-Castelan J, Arroyo-Helguera O, Pacheco P, Nicolas-Toledo L, Cuevas-Romero E. Hypothyroidism modifies differentially the content of lipids and glycogen, lipid receptors, and intraepithelial lymphocytes among oviductal regions of rabbits. Reprod Biol. 2020 Jun;20(2):247-253. doi: 10.1016/j.repbio.2020.02.004. Epub 2020 Feb 20.
- Oner J, Oner H. Immunodetection of thyroid hormone receptor (alpha1/alpha2) in the rat uterus and oviduct. Acta Histochem Cytochem. 2007 Jul 3;40(3):77-81. doi: 10.1267/ahc.06026.
- Anaya-Hernandez A, Rodriguez-Castelan J, Nicolas L, Martinez-Gomez M, Jimenez-Estrada I, Castelan F, Cuevas E. Hypothyroidism affects differentially the cell size of epithelial cells among oviductal regions of rabbits. Reprod Domest Anim. 2015 Feb;50(1):104-11. doi: 10.1111/rda.12455. Epub 2014 Nov 18.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 25, 2022
Primary Completion (Actual)
December 5, 2022
Study Completion (Actual)
December 5, 2022
Study Registration Dates
First Submitted
June 26, 2022
First Submitted That Met QC Criteria
June 30, 2022
First Posted (Actual)
July 6, 2022
Study Record Updates
Last Update Posted (Estimate)
December 6, 2022
Last Update Submitted That Met QC Criteria
December 5, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SiirtU
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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