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

Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01856894
• Other study ID #: PCODHC
• Status: Completed
• Phase: N/A
• First received: May 14, 2013
• Last updated: February 16, 2014
• Start date: May 2013
• Est. completion date: August 2013

Study information

• Verified date: February 2014
• Source: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 12 Years to 20 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome

Locations

Country	Name	City	State
Turkey	Bakirkoy Dr Sadi Konuk Teaching and Research Hospital, Department of Obstetrics and Gynecology	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ovarian reserve, as measured by basal follicle stimulating hormone/anti-Mullerian hormone/antral follicle count		Three months	No
Secondary	Body weight		Three months	No