Clinical trial NCT03398603: Is the Concentration of Anti-Muellerian Hormon (AMH) Depending on the Menstrual Cycle?
Official title: Is the Concentration of Anti-Muellerian Hormon (AMH) Depending on the Menstrual Cycle?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Failure
Keywords: AMH measurement "ElecSys"
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Roche Diagnostic Ltd.
First posted: 2018-01-12
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 50 healthy female probands

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.

Eligibility criteria: 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.

Primary outcomes:
measure: between cycle reliability of ovarian reserve assessment based on AMH serum concentration
timeFrame: 3 months
Secondary outcomes:
measure: number of ovarian follicles as made visible by 3D ultrasound
timeFrame: 3 months
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Klinik für Gyn. Endokrinologie und Reproduktionsmedizin der Frauenklinik des Universitätsspitals
Study officials:
affiliation: USB
name: Christian De Geyter, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Biniasch M, Laubender RP, Hund M, Buck K, De Geyter C. Intra- and inter-cycle variability of anti-Mullerian hormone (AMH) levels in healthy women during non-consecutive menstrual cycles: the BICYCLE study. Clin Chem Lab Med. 2021 Oct 29;60(4):597-605. doi: 10.1515/cclm-2021-0698. Print 2022 Mar 28.