Is the Concentration of Anti-Muellerian Hormon (AMH) Depending on the Menstrual Cycle?

Study Overview
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Brief Summary
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The developement of a new, stable measurement of the Antimuellerian Hormon (AMH) together with Roche Diagnostics International (Rotkreuz, CH) shall enable an automized and timely measurement of AMH values in blood samples.

Detailed Description
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An important requirement for the use of the new measurement to determine the AMH concentration is the stability of the AMH level over the menstrual cycle. So far the unbiased AMH concentration is the most important argument to manage this parameter. There are several studies, which give different professional opinions of the AMH concentration depending on the phase of the menstrual cycle. Some authors came to the conclusion that the AMH concentration over the menstrual cycle is constant, others described significant fluctuations. It is unclear, if the described fluctuation is relevant for the interpretation of the ovarian reserve. Recently it could be shown, that intraindividual fluctuations of joung women during the menstrual cycle is stronger, which means that the measurement of AMH in this age is less secure. The primary goal of the study is to evaluate, if the new AMH measurement with the ElecSys method delivers stable values over the menstrual cycle. The secondary goal of the study is to determine whether there are any fluctuations in the number of antral follicles as given by 3D ultrasound. For this reason we are recruiting a group of 50 women within two categories of age to measure eventually changes in AMH- concentration during their menstrual cycle.

Official Title
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Is the Concentration of Anti-Muellerian Hormon (AMH) Depending on the Menstrual Cycle?

Conditions
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Ovarian Failure

Intervention / Treatment
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* Procedure: blood sample and ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Regular natural menstrual cycle between 24 and 32 days Body Mass Index (BMI) between 19 and 26 kg/m2 Negative serum titer for HIV, Hepatitis B and Hepatitis C Non-smoker Willingness to visit the clinic every second day of two non-consecutive menstrual cycles. Exclusion Criteria: Intake of hormonal medication like contraceptives Pregnancy/breast feeding Known infertility Known former or actual hormonal disorder Polycystic ovarial syndrom (PCOS) Participation on another clinical trial during the last 3 months.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>25 women with age of 18-25 years | Procedure: blood sample and ultrasound<br>* When included in the study blood samples and ultrasound are taken every second day of the first and third menstrual cycle after inclusion.<br>|
| Group 2<br>25 women with age of 26-40 years | Procedure: blood sample and ultrasound<br>* When included in the study blood samples and ultrasound are taken every second day of the first and third menstrual cycle after inclusion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| between cycle reliability of ovarian reserve assessment based on AMH serum concentration | stabile assessment of ovarian reserve with AMH (pmol/l) in blood | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of ovarian follicles as made visible by 3D ultrasound | Fluctuations of antral follicle count during different menstrual cycles | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AMH measurement ElecSys