Ovarian Reserve and Ankylosing Spondylitis

NCT ID: NCT04209881

Last Updated: 2020-05-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-12-19
• Study Completion Date: 2020-05-19

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

ovarian reserve for Ankylosing spondylitis and control groups

Intervention Type: 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

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.

ovarian reserve for Ankylosing spondylitis and control groups

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Kanuni Sultan Suleyman Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Pınar Kadirogulları

Principal investigator, Pınar kadirogullari, M.D, Department of Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kanuni Sultan Süleyman Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: DERIVED

PMID: 33030584 (View on PubMed)

Other Identifiers

2019/456.14.10.2019

Identifier Type: -

Identifier Source: org_study_id