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CompletedNCT04209881Updated May 22, 2020

Ovarian Reserve and Ankylosing Spondylitis

An observational study in Ovarian Diseases, Ankylosing Spondylitis and Anti-Mullerian Hormone Deficiency, sponsored by Kanuni Sultan Suleyman Training and Research Hospital. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-22.

Sponsored by Kanuni Sultan Suleyman Training and Research Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

02

Conditions studied

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

Keywords

  • Ankylosing spondylitis
  • fertility
  • anti-müllerian hormone
  • ovarian reserve
03

In context

Spondylitis

623 studies on the registry are indexed under Spondylitis; 83 are open to participants now.

This study's enrollment of 50 is below the median of 202 across 256 observational studies indexed under Spondylitis.

Browse Spondylitis studies →

Lead sponsor

Kanuni Sultan Suleyman Training and Research Hospital is the lead sponsor of 216 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
50 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Otherovarian 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.

06

What researchers measure

Primary outcomes

  1. anti-müllerian hormone (AMH)

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

    Time frame: 3 days

  2. antral follicle count (AFC)

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

    Time frame: 1 day

07

Study locations

1 site
  • Kanuni Sultan Süleyman Training and Research Hospital
    Istanbul, 33404, Turkey
08

References and documents

Publications

  • 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. PubMed 33030584 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04209881
Lead sponsor
Kanuni Sultan Suleyman Training and Research Hospital
Responsible party
Pınar Kadirogulları (Principal investigator, Pınar kadirogullari, M.D, Department of Obstetrics and Gynecology, Kanuni Sultan Suleyman Training and Research Hospital) — Principal investigator
First posted
Dec 24, 2019
Start date
Dec 19, 2019
Primary completion
May 19, 2020
Completion
May 19, 2020
Last update
May 22, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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