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

Ovarian Failure Clinical Trial

— Bicycle  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03398603
• Other study ID #: 2016-01824
• Status: Completed
• Start date: November 1, 2016
• Est. completion date: October 13, 2019

Study information

• Verified date: January 2020
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 13, 2019
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ovarian Failure

Intervention

Procedure:
• blood 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.

Locations

Country	Name	City	State
Switzerland	Klinik für Gyn. Endokrinologie und Reproduktionsmedizin der Frauenklinik des Universitätsspitals	Basel

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Roche Diagnostic Ltd.

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	number of ovarian follicles as made visible by 3D ultrasound	Fluctuations of antral follicle count during different menstrual cycles	3 months