Skip to main content
OpenTrials
Completed

NCT Number: NCT03398603

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Klinik für Gyn. Endokrinologie und Reproduktionsmedizin der Frauenklinik des Universitätsspitals

Basel, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

blood sample and ultrasound

Procedure

When included in the study blood samples and ultrasound are taken every second day of the first and third menstrual cycle after inclusion.

Primary outcomes

  1. between cycle reliability of ovarian reserve assessment based on AMH serum concentration

    Time frame: 3 months

    stabile assessment of ovarian reserve with AMH (pmol/l) in blood

Secondary outcomes

  1. number of ovarian follicles as made visible by 3D ultrasound

    Time frame: 3 months

    Fluctuations of antral follicle count during different menstrual cycles

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Roche Diagnostic Ltd.

Registry information

Acronym: Bicycle

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Jan 12, 2018
Registry last updated
Jan 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.