NCT05446012

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 25, 2022

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 26, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 6, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2022

Completed
Last Updated

December 6, 2022

Status Verified

December 1, 2022

Enrollment Period

5 months

First QC Date

June 26, 2022

Last Update Submit

December 5, 2022

Conditions

Keywords

Thyroid disorderspregnancyEctopic

Outcome Measures

Primary Outcomes (1)

  • Thyroid dysfunction and ectopic pregnancy

    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

Study Arms (2)

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

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

Interventions

thyroid function testsDIAGNOSTIC_TEST

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

Control group pregnants (n:40)women diagnosed with ectopic pregnancy (n: 40)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

women over 18 years of age diagnosed with ectopic pregnancy or early pregnancy

You may qualify if:

  • \>18 years of age
  • Having an early pregnancy or ectopic pregnancy

You may not qualify if:

  • using medications due to thyroid gland dysfunction
  • history of ectopic pregnancy
  • history of tubal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siirt Üniversity Medical Faculty

Siirt, 56000, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 32089504BACKGROUND
  • 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.

    PMID: 17653299BACKGROUND
  • 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.

    PMID: 25405800BACKGROUND

MeSH Terms

Conditions

Pregnancy, EctopicThyroid DiseasesChoristoma

Interventions

Thyroid Function Tests

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesEndocrine System DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, EndocrineDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Şerif Aksin

    Siirt University Medical Faculty Obstetrics and Gynecology Departmant

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

June 26, 2022

First Posted

July 6, 2022

Study Start

June 25, 2022

Primary Completion

December 5, 2022

Study Completion

December 5, 2022

Last Updated

December 6, 2022

Record last verified: 2022-12

Locations