Serum Anti-Mullerian Hormone (AMH) Levels in Overweight and Obese Adolescent Girls With Polycystic Ovaries

NCT ID: NCT01856894

Last Updated: 2014-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-31

Study Completion Date

2013-08-31

Brief Summary

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In this study the investigators aimed to investigate whether there is a relation between body weight and serum anti mullerian hormone levels in adults with polycystic ovary syndrome. For this purpose the investigators designed a prospective study including three groups. The group I is defined as adults with polycystic ovary syndrome and body mass index is greater than 25. The group II is defined as adults with polycystic ovary syndrome and body mass index is less than 25. The group III is defined as adults with non-polycystic ovary syndrome and body mass index is less than 25. The all three groups are compared considering their serum AMH levels,lipid profiles, sex steroids and glycemic analyses.

Detailed Description

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In this study the investigators aimed to investigate whether there is a relation between body weight and serum anti mullerian hormone levels in adults with polycystic ovary syndrome. For this purpose the investigators designed a prospective study including three groups. The diagnosis of polycystic ovary syndrome was made in the presence of ;oligo- and/or anovulation,clinical and/or biochemical signs of hyperandrogenism and polycystic ovaries. Clinical hyperandrogenism was defined by the presence of hirsutism , acne, or the presence of androgenic alopecia , biochemical hyperandrogenemia was defined as a serum level of total testosterone higher than 2.60 nmol/L, body mass index (BMI) was calculated as weight in kilograms divided by the square of height in meters. The patients were classified as obese with BMI ≥ 25 kg/m2 , adolescent patients were diagnosed 2 years after menarche in order to avoid the misdiagnosis of transitory functional hyperandrogenism and menstrual disorders during puberty. The all three groups are compared considering their serum AMH levels,lipid profiles, sex steroids and glycemic analyses.

Conditions

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Polycystic Ovary Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

The participants with the following findings;oligo- and/or anovulation, clinical and/or biochemical signs of hyperandrogenism and polycystic ovaries, presence in each ovary of 12 or more follicles measuring 2-9 mm in diameter and/or increased ovarian volume (\> 10 mL).

Exclusion Criteria

The participants with the following findings;pregnancy,breastfeeding,known liver disease or alanine aminotransferase (60 IU/l), creatinine (130 mmol/l), known alcohol abuse, diabetes mellitus and treatment with oral glucocorticoids or hormonal contraceptives.

Patients could be included if hormonal contraception had been discontinued at least 1 month previously.
Minimum Eligible Age

12 Years

Maximum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bakirkoy Dr. Sadi Konuk Research and Training Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hüseyin Cengiz, M.D.

Role: STUDY_DIRECTOR

Bakirkoy Dr Sadi Konuk Teaching and Research Hospital, Department of Obstetrics and Gynecology

Cihan Kaya, M.D.

Role: PRINCIPAL_INVESTIGATOR

Bakirkoy Dr Sadi Konuk Teaching and Research Hospital, Department of Obstetrics and Gynecology

Şükrü Yıldız, M.D.

Role: PRINCIPAL_INVESTIGATOR

Bakirkoy Dr Sadi Konuk Teaching and Research Hospital, Department of Obstetrics and Gynecology

Hediye Dağdeviren, M.D.

Role: PRINCIPAL_INVESTIGATOR

Bakirkoy Dr Sadi Konuk Teaching and Research Hospital, Department of Obstetrics and Gynecology

Locations

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Bakirkoy Dr Sadi Konuk Teaching and Research Hospital, Department of Obstetrics and Gynecology

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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PCODHC

Identifier Type: -

Identifier Source: org_study_id

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