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CompletedNCT03897400Updated Oct 23, 2019

Ovarian Reserve in Crohn's Disease

An observational study in Crohn Disease, Ovary Disease and Anti-Mullerian Hormone Deficiency, sponsored by Kanuni Sultan Suleyman Training and Research Hospital. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-23.

Sponsored by Kanuni Sultan Suleyman Training and Research Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 40 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Crohn Disease
  • Ovary Disease
  • Anti-Mullerian Hormone Deficiency

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03

In context

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.

This study's enrollment of 100 is below the median of 162 across 608 observational studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

Kanuni Sultan Suleyman Training and Research Hospital is the lead sponsor of 216 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
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.

Inclusion criteria

  • crohn's disease;
  • reproductive age women

Exclusion criteria

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.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherAMH 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.

06

What researchers measure

Primary outcomes

  1. AMH levels

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

    Time frame: 1 MONTH

Secondary outcomes

  1. 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.

    Time frame: 1 MONTH

07

Study locations

1 site
  • Kanuni Sultan Süleyman Training and Research Hospital
    Istanbul, 33404, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 23, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03897400
Lead sponsor
Kanuni Sultan Suleyman Training and Research Hospital
Responsible party
Pınar Kadirogulları (pınar kadiroğulları, M.D, Department of Obstetrics and Gynecology, Kanuni Sultan Suleyman Training and Research Hospital) — Principal investigator
First posted
Apr 1, 2019
Start date
Mar 1, 2019
Primary completion
Sep 1, 2019
Completion
Sep 1, 2019
Last update
Oct 23, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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