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Completed

NCT Number: NCT04209881

Ovarian Reserve and Ankylosing Spondylitis

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 24, 2019
Registry last updated
May 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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