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

February 16, 2014 updated by: Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Is Serum Anti-Mullerian Hormone (AMH) Level Associated With Body Weight, Glycemic and Lipidemic Markers in Adolescent Girls With Polycystic Ovaries?

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34250
        • Bakirkoy Dr Sadi Konuk Teaching and Research Hospital, Department of Obstetrics and Gynecology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ovarian reserve, as measured by basal follicle stimulating hormone/anti-Mullerian hormone/antral follicle count
Time Frame: Three months
Three months

Secondary Outcome Measures

Outcome Measure
Time Frame
Body weight
Time Frame: Three months
Three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Investigators

  • Principal Investigator: Cihan Kaya, M.D., Bakirkoy Dr Sadi Konuk Teaching and Research Hospital, Department of Obstetrics and Gynecology
  • Study Director: Hüseyin Cengiz, M.D., Bakirkoy Dr Sadi Konuk Teaching and Research Hospital, Department of Obstetrics and Gynecology
  • Principal Investigator: Şükrü Yıldız, M.D., Bakirkoy Dr Sadi Konuk Teaching and Research Hospital, Department of Obstetrics and Gynecology
  • Principal Investigator: Hediye Dağdeviren, M.D., Bakirkoy Dr Sadi Konuk Teaching and Research Hospital, Department of Obstetrics and Gynecology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

May 14, 2013

First Submitted That Met QC Criteria

May 17, 2013

First Posted (Estimate)

May 20, 2013

Study Record Updates

Last Update Posted (Estimate)

February 19, 2014

Last Update Submitted That Met QC Criteria

February 16, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCODHC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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