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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04455256
Other study ID # tgk-xbp
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 20, 2020
Est. completion date July 7, 2020

Study information

Verified date July 2020
Source Kanuni Sultan Suleyman Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To evaluate endoplasmic reticulum stress in women with recurrent pregnancy loss and those who had healthy births in the same age group. The level of the unfolded protein X box binding protein 1 (XBP-1) is measured. It is aimed to show the effect of endoplasmic reticulum stress on recurrent pregnancy loss.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date July 7, 2020
Est. primary completion date July 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- with three or more miscarriages before 20 th week of gestation

- had no chronic or acute inflammatory disease

- used no steroids, anti-inflammatory, or antioxidant medications

Exclusion Criteria:

- had inflammatory diseases

- had systemic disease

- Anatomical abnormalities, infectious, endocrine, or genetic etiologies

Study Design


Intervention

Other:
x box binding protein
Serum value (pg / mL) of x box binding protein (XBP-1), which is one of the unfolded proteins indicating endoplasmic reticulum stress, is measured.

Locations

Country Name City State
Turkey Pinar Yalcin Bahat Istanbul I?stanbul

Sponsors (1)

Lead Sponsor Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Show the effect of endoplasmic reticulum stress on recurrent pregnancy loss Serum value (pg / mL) of x box binding protein (XBP-1), which is one of the unfolded proteins indicating endoplasmic reticulum stress, is measured. 3 months
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