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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03398603
Other study ID # 2016-01824
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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