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Clinical Trials/NCT04209881
NCT04209881CompletedNot Applicable

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

Kanuni Sultan Suleyman Training and Research Hospital1 site in 1 country50 target enrollmentStarted: December 19, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
50
Locations
1
Primary Endpoint
anti-müllerian hormone (AMH)

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

anti-müllerian hormone (AMH)

Time Frame: 3 days

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

antral follicle count (AFC)

Time Frame: 1 day

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Pınar Kadirogulları

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

Kanuni Sultan Suleyman Training and Research Hospital

Study Sites (1)

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