Ovarian Failure
Conditions
Keywords
AMH measurement ElecSys
Brief summary
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
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.
Interventions
PROCEDUREblood sample and ultrasound
When included in the study blood samples and ultrasound are taken every second day of the first and third menstrual cycle after inclusion.
Sponsors
Roche Diagnostic Ltd.
University Hospital, Basel, Switzerland
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| between cycle reliability of ovarian reserve assessment based on AMH serum concentration | 3 months | stabile assessment of ovarian reserve with AMH (pmol/l) in blood |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| number of ovarian follicles as made visible by 3D ultrasound | 3 months | Fluctuations of antral follicle count during different menstrual cycles |
Countries
Switzerland
Outcome results
None listed