Ovarian Reserve in Crohn's Disease

NCT03897400 | Completed

• 1 other identifier: 2019.03.40
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn Disease; Ovary Disease; Anti-Mullerian Hormone Deficiency

Outcome Measures

Primary Outcomes (1)

• AMH levels

  AMH levels of subjects taken into groups will be evaluated in lg/L

  1 MONTH

Secondary Outcomes (1)

• ultrasound findings

  1 MONTH

Study Arms (2)

study group

women in reproductive age with crohn's disease

Other: AMH levels in young women with crohn's disease will be considered.

control group

women in reproductive age without crohn's disease,

Other: AMH levels in young women with crohn's disease will be considered.

Interventions

AMH levels in young women with crohn's disease will be considered. OTHER

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; study group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• crohn's disease;
• reproductive age women

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

Study Sites (1)

Kanuni Sultan Süleyman Training and Research Hospital

Istanbul, 33404, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Crohn Disease; Ovarian Diseases

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: pınar kadiroğulları, M.D, Department of Obstetrics and Gynecology

Study Record Dates

• First Submitted: March 27, 2019
• First Posted: April 1, 2019
• Study Start: March 1, 2019
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: October 23, 2019

Record last verified: 2019-10

Locations

TU (1)