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

Completed

• Conditions: Ovarian Failure
• Interventions: Procedure: blood sample and ultrasound

• Registration Number: NCT03398603
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Study Timeline

• Study Start: 2016-11-01
• Study First Submitted: 2017-12-26
• Study First Submitted QC: 2018-01-07
• Study First Posted: 2018-01-12
• Primary Completion: 2018-08-31
• Study Completion: 2019-10-13
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-25
• Last Update Posted: 2020-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2	blood sample and ultrasound	25 women with age of 26-40 years
Group 1	blood sample and ultrasound	25 women with age of 18-25 years

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
number of ovarian follicles as made visible by 3D ultrasound	3 months	Fluctuations of antral follicle count during different menstrual cycles

Trial Locations

Locations (1)

Klinik für Gyn. Endokrinologie und Reproduktionsmedizin der Frauenklinik des Universitätsspitals; 🇨🇭 Basel, Switzerland