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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03897400
Other study ID # 2019.03.40
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2019
Est. completion date September 1, 2019

Study information

Verified date October 2019
Source Kanuni Sultan Suleyman Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Crohn's disease reduces fertility by inducing inflammation both directly and in the fallopian tubes and ovaries and indirectly through surgical interventions and tubal adhesions associated with disease treatment. Anti-mullerian hormone (AMH) is a reliable indicator of ovarian reserve in women. The aim of this study was to compare serum AMH levels in women with Crohn's disease and healthy controls. In this study, the investigators aimed to investigate AMH and ovarian capacity in the study group with crohn's disease and in the control group without disease.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date September 1, 2019
Est. primary completion date September 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- crohn's disease;

- reproductive age women

Exclusion Criteria:

- Over 40 years old,

- a previous ovarian resection;

- renal failure (serum creatinine levels N1.2 mg / dL);suspicion of malignancy;

- the presence of hereditary or acquired hematological disease;

- pregnancy;

- current lactation;

- the presence of a serious comorbid chronic disease;

- cirrhosis originating from chronic liver disease;

- abnormal thyroid function tests;

- a known serious psychological problem;

- presence of alcoholism and male sex.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
AMH levels in young women with crohn's disease will be considered.
Ovarian Reserve in Young Women of Reproductive Age with Crohn's Disease;Blood will be taken from both the study and control groups and the AMH level will be evaluated.

Locations

Country Name City State
Turkey Kanuni Sultan Süleyman Training and Research Hospital Istanbul

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 AMH levels AMH levels of subjects taken into groups will be evaluated in lg/L 1 MONTH
Secondary ultrasound findings On the 3rd day of the menstrual cycle, the patients will be given ultrasound and the ovarian volume will be examined. the ovarian volume will be calculated by taking the size of the ovary in three sections. 1 MONTH
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