Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ovarian Reserve and Ankylosing Spondylitis

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04209881
Recruitment Status : Completed
First Posted : December 24, 2019
Last Update Posted : May 22, 2020
Sponsor:
Information provided by (Responsible Party):
Pınar Kadirogulları, Kanuni Sultan Suleyman Training and Research Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment
Ovarian Diseases Ankylosing Spondylitis Anti-Mullerian Hormone Deficiency Other: ovarian reserve for Ankylosing spondylitis and control groups

Layout table for study information
Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Evaluation of Ovarian Reserve Using Anti-müllerian Hormone and Antral Follicle Count in Ankylosing Spondylitis: Preliminary Study
Actual Study Start Date : December 19, 2019
Actual Primary Completion Date : May 19, 2020
Actual Study Completion Date : May 19, 2020

Resource links provided by the National Library of Medicine


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.

Other: ovarian reserve for Ankylosing spondylitis and control groups

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.

Other: ovarian reserve for Ankylosing spondylitis and control groups

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.





Primary Outcome Measures :
  1. anti-müllerian hormone (AMH) [ Time Frame: 3 days ]
    For ovarian capacity AMH will be examined and AMH levels will be recorded in pmol/l

  2. antral follicle count (AFC) [ Time Frame: 1 day ]
    For ovarian capacity AFC will be examined and It will be recorded as a NUMBER.



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 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Women who are diagnosed with ankylosing spondylitis will form the study group.
Criteria

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.

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): NCT04209881


Locations
Layout table for location information
Turkey
Kanuni Sultan Süleyman Training and Research Hospital
Istanbul, Turkey, 33404
Sponsors and Collaborators
Kanuni Sultan Suleyman Training and Research Hospital
Layout table for additonal information
Responsible Party: Pınar Kadirogulları, Principal investigator, Pınar kadirogullari, M.D, Department of Obstetrics and Gynecology, Kanuni Sultan Suleyman Training and Research Hospital
ClinicalTrials.gov Identifier: NCT04209881    
Other Study ID Numbers: 2019/456.14.10.2019
First Posted: December 24, 2019    Key Record Dates
Last Update Posted: May 22, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pınar Kadirogulları, Kanuni Sultan Suleyman Training and Research Hospital:
Ankylosing spondylitis
fertility
anti-müllerian hormone
ovarian reserve
Additional relevant MeSH terms:
Layout table for MeSH terms
Spondylitis
Spondylitis, Ankylosing
Ovarian Diseases
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases