Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ovarian Reserve in Crohn's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03897400
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
Pınar Kadirogulları, Kanuni Sultan Suleyman Training and Research Hospital

Brief 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.

Condition or disease Intervention/treatment
Crohn Disease Ovary Disease Anti-Mullerian Hormone Deficiency Other: AMH levels in young women with crohn's disease will be considered.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Evaluation of Ovarian Reserve in Crohn's Disease
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

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.




Primary Outcome Measures :
  1. AMH levels [ Time Frame: 1 MONTH ]
    AMH levels of subjects taken into groups will be evaluated in lg/L


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study group consisted of young women in the reproductive age with crohn's disease.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03897400


Locations
Layout table for location information
Turkey
Kanuni Sultan Süleyman Training and Research Hospital Recruiting
Istanbul, Turkey, 33404
Contact: pınar kadiroğulları, MD    +095054947235    pinarsezer33@hotmail.com   
Sponsors and Collaborators
Kanuni Sultan Suleyman Training and Research Hospital

Layout table for additonal information
Responsible Party: Pınar Kadirogulları, pınar kadiroğulları, M.D, Department of Obstetrics and Gynecology, Kanuni Sultan Suleyman Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03897400     History of Changes
Other Study ID Numbers: 2019.03.40
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Crohn Disease
Ovarian Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Gastroenteritis