Is the Concentration of Anti-Muellerian Hormon (AMH) Depending on the Menstrual Cycle?
NCT ID: NCT03398603
Last Updated: 2020-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
50 participants
OBSERVATIONAL
2016-11-01
2019-10-13
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Group 1
25 women with age of 18-25 years
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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
40 Years
FEMALE
Yes
Sponsors
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Roche Diagnostic Ltd.
INDUSTRY
University Hospital, Basel, Switzerland
OTHER
Responsible Party
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Christian De Geyter
Professor
Principal Investigators
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Christian De Geyter, Prof.
Role: PRINCIPAL_INVESTIGATOR
USB
Locations
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Klinik für Gyn. Endokrinologie und Reproduktionsmedizin der Frauenklinik des Universitätsspitals
Basel, , Switzerland
Countries
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References
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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.
Other Identifiers
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2016-01824
Identifier Type: -
Identifier Source: org_study_id
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