Relationship Between Ectopic Pregnancy and Thyroid Disorders

NCT ID: NCT05446012

Last Updated: 2022-12-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 62 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-25
• Study Completion Date: 2022-12-05

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.

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.

Conditions

Ectopic Pregnancy; Thyroid Diseases; Pregnancy, Ectopic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

thyroid function tests

Intervention Type: DIAGNOSTIC_TEST

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.

thyroid function tests

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

thyroid function tests

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Siirt University

OTHER

Sponsor Role: lead

Responsible Party

Serif Aksin

associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Şerif Aksin

Role: PRINCIPAL_INVESTIGATOR

Siirt University Medical Faculty Obstetrics and Gynecology Departmant

Locations

Siirt Üniversity Medical Faculty

Siirt, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 32089504 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17653299 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25405800 (View on PubMed)

Other Identifiers

SiirtU

Identifier Type: -

Identifier Source: org_study_id