Ovarian DiseasesNCT04209881
Ovarian Reserve and Ankylosing Spondylitis
An observational study of Ovarian Diseases and Ankylosing Spondylitis, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
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). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Diseases, Ankylosing Spondylitis, Anti-Mullerian Hormone Deficiency
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Dec 2019to 19 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women who are diagnosed with ankylosing spondylitis will form the study group.
Who may be able to join
- regular menstruation with intervals of 21-35 days;
- cycle length variations <4 days;
- both ovaries still present
Who cannot join
- history of liver failure;
- diagnosed malignancy;
- cigarette smoking;
- chronic renal failure;
- known infertility;
- presence of gynecological abnormalities such as abnormal uterine bleeding or menorrhagia;
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- history of ovarian surgery;
- history of hormone preparation (including corticosteroids) use or use of herbal products within 3 months;
- diagnosis of polycystic ovary syndrome.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kanuni Sultan Süleyman Training and Research Hospital
Istanbul, 33404
About this study
Official title: Evaluation of Ovarian Reserve Using Anti-müllerian Hormone and Antral Follicle Count in Ankylosing Spondylitis: Preliminary Study
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.
- Being tested
- ovarian reserve for Ankylosing spondylitis and control groups
- Keywords
- Ankylosing spondylitis, fertility, anti-müllerian hormone, ovarian reserve
- Medical subject headings
- Ovarian Diseases, Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ovarian reserve for Ankylosing spondylitis and control groupsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: ovarian reserve for Ankylosing spondylitis and control groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
anti-müllerian hormone (AMH)
For ovarian capacity AMH will be examined and AMH levels will be recorded in pmol/l
Measured: 3 days
antral follicle count (AFC)
For ovarian capacity AFC will be examined and It will be recorded as a NUMBER.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study start19 Dec 2019
- Primary completion19 May 2020
- Study completion19 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar Kadirogulları, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04209881
- Sponsor's protocol ID
- 2019/456.14.10.2019
- Status last verified
- May 2020
- First submitted
- 19 Dec 2019
- Last updated
- 22 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Ovarian Reserve Using Anti-müllerian Hormone and Antral Follicle Count in Ankylosing Spondylitis: Preliminary Study
- ClinicalTrials.gov ID
- NCT04209881
- Acronym / sponsor ID
- 2019/456.14.10.2019
- Keywords
- Ankylosing spondylitis, fertility, anti-müllerian hormone, ovarian reserve
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 19 Dec 2019 (actual)
- Primary completion
- 19 May 2020 (actual)
- Study completion
- 19 May 2020 (actual)
- First posted
- 24 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Ankylosing spondylitis | – | Other: ovarian reserve for Ankylosing spondylitis and control groupsWomen 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. |
| Healthy women as controls | – | Other: ovarian reserve for Ankylosing spondylitis and control groupsRegular 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women who are diagnosed with ankylosing spondylitis will form the study group.
Key inclusion criteria (3 listed)
- regular menstruation with intervals of 21-35 days;
- cycle length variations <4 days;
- both ovaries still present
Key exclusion criteria (9 listed)
- history of liver failure;
- diagnosed malignancy;
- cigarette smoking;
- chronic renal failure;
- known infertility;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ovarian reserve for Ankylosing spondylitis and control groupsAdditional 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. | Other | Healthy women as controls, Patients with Ankylosing spondylitis |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2020.
- Derived from this study: PubMed 33030584Yalcin 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Diseases and Ankylosing Spondylitis, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anti-müllerian hormone (AMH) (time frame: 3 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04209881, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2020.