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CompletedNCT04371133Updated May 1, 2020

Anti-inflammatory Markers in Endometrioma

An observational study in Endometrioma and Inflammation, sponsored by Muğla Sıtkı Koçman University. Completed at 1 site in Turkey. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-01.

Sponsored by Muğla Sıtkı Koçman University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
48
Ages
18 Years and older
Sex
Female
01

Study summary

Investigators aimed to measure the serum levels of adropin, salusin-α, netrin-1, and nesfatin-1, anti-inflammatory effects of which have been demonstrated previously, in endometriosis patients and to find out any association of them with insulin resistance.

Read the detailed description

Endometriosis is defined as the presence of endometrial gland and stroma outside the endometrial cavity affecting almost 10% of the women of reproductive age. Although benign, it disrupts the quality of life of the inflicted patients through symptoms such as dysmenorrhae, dyspareunia, chronic pelvic pain, and infertility. The pathogenesis of endometriosis has not yet been clearly elucidated, however, recent papers implies an underpinning role of inflammation There is a limited number of studies about the levels of these parameters in endometriosis and to date, no report is available on the levels of adropin and netrin-1 in endometriosis. Likewise, according to the investigator's literature search, no research explaining the association of endometriosis with insulin resistance has yet been published. In present study, in an attempt to describe inflammatory pathways playing a role in endometriosis pathogenesis, Investigators aimed to measure the levels of serum adropin, salusin-α, netrin-1, and nesfatin-1, anti-inflammatory effects of which have been priorly demonstrated, and to find out any association of them with insulin resistance.

02

Conditions studied

  • Endometrioma
  • Inflammation

Keywords

  • endometrioma
  • adropin
  • salusin-α
  • netrin-1
  • nesfatin-1
  • insulin resistance
03

In context

Endometriosis

901 studies on the registry are indexed under Endometriosis; 259 are open to participants now.

This study's enrollment of 48 is below the median of 128 across 344 observational studies indexed under Endometriosis.

Browse Endometriosis studies →

Lead sponsor

Muğla Sıtkı Koçman University is the lead sponsor of 112 studies on the registry; 19 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

Laporoscopically and histopathologically diagnosed 23 endometrioma patients and 25 healthy individuals with no endometrioma constituting the control group were included to this study.

Inclusion criteria

·Histopathologically confirmed diagnosis of endometrioma

Exclusion criteria

Exclusion Criteria:

  • Any patients with DM,
  • chronic kidney disease (CKD),
  • CAD,
  • heart failure (HF),
  • cerebrovascular accident (CVA),
  • malignancy,
  • rheumatoid disorder,
  • liver disease, and
  • active infections were excluded from the study.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
48 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Endometrioma

    Endometrioma (n=23)

    Diagnostic Test: Adropin (ng/L)

  • Healthy controls

    Healthy controls Healthy volunteers n=25

    Diagnostic Test: Adropin (ng/L)

Interventions

  • Diagnostic testAdropin (ng/L)

    Thawed samples were measured on a Molecular Devices SpectraMax i3 Multi-Mode, Microplate Reader (batch number: SER 35 370-1448, made in Austria) using enzyme linked immunosorbent assay (ELISA).

    Also known as: Salusin-α (pg/mL), Netrin-1 (pg/mL), Nesfatin-1 (ng/mL)

06

What researchers measure

Primary outcomes

  1. Serum Adropin level

    Serum Adropin level in ng/L

    Time frame: preoperative in the morning or Day 1 in outpatient clinic,preprandial for healthy volunteers

  2. Salusin-α

    Serum Salusin-α level in pg/mL

    Time frame: preoperative in the morning or Day 1 in outpatient clinic, preprandial for healthy volunteers

  3. Netrin-1

    Serum Netrin-1 level in pg/mL

    Time frame: preoperative in the morning or Day 1 in outpatient clinic, preprandial for healthy volunteers

  4. Nesfatin-1

    Serum Nesfatin-1 level in ng/L

    Time frame: preoperative in the morning or Day 1 in outpatient clinic, preprandial for healthy volunteers

07

Study locations

1 site
  • Mugla Sıtkı Kocman University Faculty of Medicine
    Muğla, 48000, Turkey
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04371133
Lead sponsor
Muğla Sıtkı Koçman University
Responsible party
Burak Sezgin (Principal Investigator, Muğla Sıtkı Koçman University) — Principal investigator
First posted
May 1, 2020
Start date
Aug 15, 2018
Primary completion
Feb 15, 2020
Completion
Mar 15, 2020
Last update
May 1, 2020

Study contacts

Burak Sezgin, Dr
principal investigator · Mugla Sıtkı Kocman University Faculty of Medicine

Oversight

Data monitoring committee
Yes
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 Apr 2020. You cannot join it, but the record below documents what was studied.

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