Ovarian Reserve and Ankylosing Spondylitis

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04209881

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Diseases Ankylosing Spondylitis Anti-Mullerian Hormone Deficiency	Other: ovarian reserve for Ankylosing spondylitis and control groups

Study Design

Study Type:

Observational

Actual Enrollment :

50 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Dec 19, 2019

Actual Primary Completion Date :

May 19, 2020

Actual Study Completion Date :

May 19, 2020

Arms and Interventions

Arm	Intervention/Treatment
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 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.	Other: 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.

Arm

Intervention/Treatment

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

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.

Other: ovarian reserve for Ankylosing spondylitis and control groups

Outcome Measures

Primary Outcome Measures

anti-müllerian hormone (AMH) [3 days]
For ovarian capacity AMH will be examined and AMH levels will be recorded in pmol/l
antral follicle count (AFC) [1 day]
For ovarian capacity AFC will be examined and It will be recorded as a NUMBER.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kanuni Sultan Süleyman Training and Research Hospital	Istanbul		Turkey	33404

Sponsors and Collaborators

Kanuni Sultan Suleyman Training and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pınar Kadirogulları, Principal investigator, Pınar kadirogullari, M.D, Department of Obstetrics and Gynecology, Kanuni Sultan Suleyman Training and Research Hospital

ClinicalTrials.gov Identifier:

NCT04209881

Other Study ID Numbers:

2019/456.14.10.2019

First Posted:

Dec 24, 2019

Last Update Posted:

May 22, 2020

Last Verified:

May 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Pınar Kadirogulları, Principal investigator, Pınar kadirogullari, M.D, Department of Obstetrics and Gynecology, Kanuni Sultan Suleyman Training and Research Hospital

Ankylosing spondylitis

fertility

anti-müllerian hormone

ovarian reserve

Additional relevant MeSH terms:

Spondylitis

Spondylarthritis

Spondylitis, Ankylosing

Ovarian Diseases

Study Results

No Results Posted as of May 22, 2020