Ovarian Reserve and Ankylosing Spondylitis

May 21, 2020 updated by: Pınar Kadirogulları, Kanuni Sultan Suleyman Training and Research Hospital

Evaluation of Ovarian Reserve Using Anti-müllerian Hormone and Antral Follicle Count in Ankylosing Spondylitis: Preliminary Study

The aim of this study was to determine the status of ovarian reserve in patients with ankylosing spondylitis (AS) using anti-mullerian hormone (AMH) level and antral follicle count (AFC). Women with AS and women controls diagnosed according to the classification criteria proposed by the American-European Consensus Group will be included in the study. Ovarian reserve will be evaluated in terms of clinical findings, AFC and serum AMH and reproductive hormone levels.

Researchers predict that the ovarian reserve may be reduced in patients with AS due to the autoimmune process and the pathophysiology of the disease. Serum AMH and ovarian AFC may be useful for assessing ovarian reserve. It is aimed to determine the course of ovarian reserve abnormalities and the best possible biomarkers of reduced ovarian reserve in patients with AS.

Study Overview

Study Type

Observational

Enrollment (Actual)

50

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

      • 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 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Women who are diagnosed with ankylosing spondylitis will form the study group.

Description

Inclusion Criteria:

  • regular menstruation with intervals of 21-35 days;
  • cycle length variations <4 days;
  • both ovaries still present

Exclusion Criteria:

  • history of liver failure;
  • diagnosed malignancy;
  • cigarette smoking;
  • chronic renal failure;
  • known infertility;
  • presence of gynecological abnormalities such as abnormal uterine bleeding or menorrhagia;
  • history of ovarian surgery;
  • history of hormone preparation (including corticosteroids) use or use of herbal products within 3 months;
  • diagnosis of polycystic ovary syndrome.

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
Patients with Ankylosing spondylitis

Women Who Are Diagnosed With Ankylosing Spondylitis Will Form The Study Group. Clinical And Laboratory Parameters Will Be Evaluated For Ovarian Capacity Of These Women.In order to evaluate the ovarian reserve of the patients, the parameters we routinely look at will be evaluated as follows. the results of these tests will be observed.

Amh Will Be Looked For (Pmol / L). Antral Folukul Census In The Overin Folukular Stage Will Be Valued As Number. Fsh (Iu / L) And Estradiol (Pmol / L) Values Will Also Be Recorded.

Additional organ diseases due to the pathophysiology of the disease may be seen in women with ankylosing spondylitis. therefore, we established the first group of women with the diagnosis of ankylosing spondylitis.

Women Who Are Diagnosed With Ankylosing Spondylitis Will Form The Study Group. and health women will be control group.

Clinical And Laboratory Parameters Will Be Evaluated For Ovarian Capacity Of These Women.

Amh Will Be Looked For (Pmol / L). Antral Folukul Census In The Overin Folukular Stage Will Be Valued As Number. Fsh (Iu / L) And Estradiol (Pmol / L) Values Will Also Be Recorded.

Healthy women as controls

Regular menstruation with intervals of 21-35 days; cycle length variations <4 days; and both ovaries still present healthy women will create the control group.In order to evaluate the ovarian reserve of the patients, the parameters we routinely look at will be evaluated as follows. the results of these tests will be observed.

Amh will be looked for. (pmol / l). Antral folukul census in the overin folukular stage will be valued as number. Fsh (iu / l) and Estradiol (pmol / l) values will also be recorded.

Additional organ diseases due to the pathophysiology of the disease may be seen in women with ankylosing spondylitis. therefore, we established the first group of women with the diagnosis of ankylosing spondylitis.

Women Who Are Diagnosed With Ankylosing Spondylitis Will Form The Study Group. and health women will be control group.

Clinical And Laboratory Parameters Will Be Evaluated For Ovarian Capacity Of These Women.

Amh Will Be Looked For (Pmol / L). Antral Folukul Census In The Overin Folukular Stage Will Be Valued As Number. Fsh (Iu / L) And Estradiol (Pmol / L) Values Will Also Be Recorded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
anti-müllerian hormone (AMH)
Time Frame: 3 days
For ovarian capacity AMH will be examined and AMH levels will be recorded in pmol/l
3 days
antral follicle count (AFC)
Time Frame: 1 day
For ovarian capacity AFC will be examined and It will be recorded as a NUMBER.
1 day

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

December 19, 2019

Primary Completion (Actual)

May 19, 2020

Study Completion (Actual)

May 19, 2020

Study Registration Dates

First Submitted

December 19, 2019

First Submitted That Met QC Criteria

December 21, 2019

First Posted (Actual)

December 24, 2019

Study Record Updates

Last Update Posted (Actual)

May 22, 2020

Last Update Submitted That Met QC Criteria

May 21, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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