Ovarian Reserve and Ankylosing Spondylitis

Ankylosing Spondylitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04209881
• Other study ID #: 2019/456.14.10.2019
• Status: Completed
• Start date: December 19, 2019
• Est. completion date: May 19, 2020

Study information

• Verified date: May 2020
• Source: Kanuni Sultan Suleyman Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 19, 2020
• Est. primary completion date: May 19, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Anti-Mullerian Hormone Deficiency
• Ovarian Diseases
• Spondylitis
• Spondylitis, Ankylosing

Intervention

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.

Locations

Country	Name	City	State
Turkey	Kanuni Sultan Süleyman Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

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