Ovarian Failure Clinical Trial
— BicycleOfficial title:
Is the Concentration of Anti-Muellerian Hormon (AMH) Depending on the Menstrual Cycle?
Verified date | January 2020 |
Source | University Hospital, Basel, Switzerland |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Switzerland | Klinik für Gyn. Endokrinologie und Reproduktionsmedizin der Frauenklinik des Universitätsspitals | Basel |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Basel, Switzerland | Roche Diagnostic Ltd. |
Switzerland,
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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