Relationship Between Ectopic Pregnancy and Thyroid Disorders

Sponsor
Siirt University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05446012
Collaborator
(none)
80
1
5.2
15.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: thyroid function tests

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 Design

Study Type:
Observational
Anticipated Enrollment :
80 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Ectopic Pregnancy and Thyroid Disorders
Actual Study Start Date :
Jun 25, 2022
Anticipated Primary Completion Date :
Nov 30, 2022
Anticipated Study Completion Date :
Nov 30, 2022

Arms and Interventions

Arm 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

Diagnostic Test: thyroid function tests
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.

Diagnostic Test: thyroid function tests
blood sample for thyroid function tests (TSH,T3,T3,Anti peroxidase antibody, anti thyroglobulin antibody)

Outcome Measures

Primary Outcome Measures

  1. Thyroid dysfunction and ectopic pregnancy [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Siirt Üniversity Medical Faculty Siirt Turkey 56000

Sponsors and Collaborators

  • Siirt University

Investigators

  • Principal Investigator: Şerif Aksin, Siirt University Medical Faculty Obstetrics and Gynecology Departmant

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Serif Aksin, associate professor, Siirt University
ClinicalTrials.gov Identifier:
NCT05446012
Other Study ID Numbers:
  • SiirtU
First Posted:
Jul 6, 2022
Last Update Posted:
Jul 6, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Serif Aksin, associate professor, Siirt University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 6, 2022