Ovarian Reserve in Crohn's Disease

October 22, 2019 updated by: Pınar Kadirogulları, Kanuni Sultan Suleyman Training and Research Hospital

Evaluation of Ovarian Reserve in Crohn's Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 33404
        • Kanuni Sultan Suleyman Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

The study group consisted of young women in the reproductive age with crohn's disease.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
study group
women in reproductive age with crohn's disease
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.
control group
women in reproductive age without crohn's disease,
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AMH levels
Time Frame: 1 MONTH
AMH levels of subjects taken into groups will be evaluated in lg/L
1 MONTH

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ultrasound findings
Time Frame: 1 MONTH
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2019

Primary Completion (Actual)

September 1, 2019

Study Completion (Actual)

September 1, 2019

Study Registration Dates

First Submitted

March 27, 2019

First Submitted That Met QC Criteria

March 28, 2019

First Posted (Actual)

April 1, 2019

Study Record Updates

Last Update Posted (Actual)

October 23, 2019

Last Update Submitted That Met QC Criteria

October 22, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019.03.40

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Clinical Trials on AMH levels in young women with crohn's disease will be considered.

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