ClinicalTrials.gg
CompletedNCT05446012Updated Dec 6, 2022

Relationship Between Ectopic Pregnancy and Thyroid Disorders

An observational study in Ectopic Pregnancy, Thyroid Diseases and Pregnancy, Ectopic, sponsored by Siirt University. Completed at 1 site in Turkey. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-06.

Sponsored by Siirt University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
62
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Ectopic Pregnancy
  • Thyroid Diseases
  • Pregnancy, Ectopic

Keywords

  • Thyroid disorders
  • pregnancy
  • Ectopic
03

In context

Pregnancy, Ectopic

83 studies on the registry are indexed under Pregnancy, Ectopic; 21 are open to participants now.

This study's enrollment of 62 is below the median of 150 across 39 observational studies indexed under Pregnancy, Ectopic.

Browse Pregnancy, Ectopic studies →

Lead sponsor

Siirt University is the lead sponsor of 16 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • using medications due to thyroid gland dysfunction
  • history of ectopic pregnancy
  • history of tubal surgery
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
62 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testthyroid function tests

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

06

What researchers measure

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

    Time frame: Through study completion, an average of 5 months

07

Study locations

1 site
  • Siirt Üniversity Medical Faculty
    Siirt, 56000, Turkey
08

References and documents

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. PubMed 32089504 ↗
  • 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. PubMed 17653299 ↗
  • 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. PubMed 25405800 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2022 to primary completion in Dec 2022, 5 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 26, 2022
First posted
Jul 6, 2022
StartActual
Jun 25, 2022
Primary completionActual
Dec 5, 2022
CompletionActual
Dec 5, 2022
Last update
Dec 6, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 6, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05446012
Lead sponsor
Siirt University
Responsible party
Serif Aksin (associate professor, Siirt University) — Principal investigator
First posted
Jul 6, 2022
Start date
Jun 25, 2022
Primary completion
Dec 5, 2022
Completion
Dec 5, 2022
Last update
Dec 6, 2022

Study contacts

Şerif Aksin
principal investigator · Siirt University Medical Faculty Obstetrics and Gynecology Departmant

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion