Ovarian Reserve and Ankylosing Spondylitis

NCT04209881 | Completed

• 1 other identifier: 2019/456.14.10.2019
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Diseases; Ankylosing Spondylitis; Anti-Mullerian Hormone Deficiency

Keywords

Ankylosing spondylitis; fertility; anti-müllerian hormone; ovarian reserve

Outcome Measures

Primary Outcomes (2)

• anti-müllerian hormone (AMH)

  For ovarian capacity AMH will be examined and AMH levels will be recorded in pmol/l

  3 days

• antral follicle count (AFC)

  For ovarian capacity AFC will be examined and It will be recorded as a NUMBER.

  1 day

Study Arms (2)

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

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

Interventions

ovarian reserve for Ankylosing spondylitis and control groups OTHER

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; Patients with Ankylosing spondylitis

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

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

Related Publications (1)

• Yalcin Bahat P, Kadirogullari P, Topbas Selcuki NF, Yucel B, Cakmak K, Ureyen Ozdemir E. Ovarian reserve in patients with ankylosing spondylitis. Arch Gynecol Obstet. 2021 Jan;303(1):189-193. doi: 10.1007/s00404-020-05824-8. Epub 2020 Oct 8.

  PMID: 33030584 DERIVED

MeSH Terms

Conditions

Ovarian Diseases; Spondylitis, Ankylosing

Interventions

Ovarian Reserve; HLA-B Antigens; Control Groups

Condition Hierarchy (Ancestors)

Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Intervention Hierarchy (Ancestors)

Fertility; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Histocompatibility Antigens Class I; Membrane Glycoproteins; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins; Membrane Proteins; Histocompatibility Antigens; Antigens, Surface; Antigens; Biological Factors; HLA Antigens; Isoantigens; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

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

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: December 24, 2019
• Study Start: December 19, 2019
• Primary Completion: May 19, 2020
• Study Completion: May 19, 2020
• Last Updated: May 22, 2020

Record last verified: 2020-05

Locations

TU (1)