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

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.

Study Overview

• Status: Completed
• Conditions: Ovarian Failure
• Intervention / Treatment: Procedure: blood sample and ultrasound

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 Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Klinik für Gyn. Endokrinologie und Reproduktionsmedizin der Frauenklinik des Universitätsspitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

50 healthy female probands

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; 25 women with age of 18-25 years	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.
Group 2; 25 women with age of 26-40 years	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: Roche Diagnostic Ltd.
• Investigators: Principal Investigator: Christian De Geyter, Prof., USB

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): August 31, 2018
• Study Completion (Actual): October 13, 2019

Study Registration Dates

• First Submitted: December 26, 2017
• First Submitted That Met QC Criteria: January 7, 2018
• First Posted (Actual): January 12, 2018

Study Record Updates

• Last Update Posted (Actual): January 28, 2020
• Last Update Submitted That Met QC Criteria: January 25, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: AMH measurement "ElecSys"
• Other Study ID Numbers: 2016-01824

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No