Ovarian FailureBicycleNCT03398603
Is the Concentration of Anti-Muellerian Hormon (AMH) Depending on the Menstrual Cycle?
An observational study of Ovarian Failure, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Failure
- What is being tested?
- blood sample and ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Nov 2016to 13 Oct 2019
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 50 healthy female probands
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Klinik für Gyn. Endokrinologie und Reproduktionsmedizin der Frauenklinik des Universitätsspitals
Basel, 4031
About this study
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.
Read the 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.
- Conditions
- Ovarian Failure
- Being tested
- blood sample and ultrasound
- Keywords
- AMH measurement "ElecSys"
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sample and ultrasoundProcedure or surgery
When included in the study blood samples and ultrasound are taken every second day of the first and third menstrual cycle after inclusion.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | 25 women with age of 18-25 years Receives: Procedure: blood sample and ultrasound | |
| Group 2 | 25 women with age of 26-40 years Receives: Procedure: blood sample and ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
between cycle reliability of ovarian reserve assessment based on AMH serum concentration
stabile assessment of ovarian reserve with AMH (pmol/l) in blood
Measured: 3 months
Secondary outcomes (1)
number of ovarian follicles as made visible by 3D ultrasound
Fluctuations of antral follicle count during different menstrual cycles
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study start1 Nov 2016
- Primary completion31 Aug 2018
- Study completion13 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Diagnostic Ltd.
- Responsible party
- Principal investigator, Christian De Geyter, University Hospital, Basel, Switzerland
- Investigators
- Christian De Geyter, Prof., Principal investigator, USB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03398603
- Sponsor's protocol ID
- 2016-01824
- Other IDs
- 2016
- Acronym
- Bicycle
- Status last verified
- Jan 2020
- First submitted
- 26 Dec 2017
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34717057
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Concentration of Anti-Muellerian Hormon (AMH) Depending on the Menstrual Cycle?
- ClinicalTrials.gov ID
- NCT03398603
- Acronym / sponsor ID
- Bicycle / 2016-01824
- Conditions
- Ovarian Failure
- Keywords
- AMH measurement "ElecSys"
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Roche Diagnostic Ltd.
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 13 Oct 2019 (actual)
- First posted
- 12 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Procedure: blood sample and ultrasound25 women with age of 18-25 years |
| Group 2 | – | Procedure: blood sample and ultrasound25 women with age of 26-40 years |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 50 healthy female probands
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- Intake of hormonal medication like contraceptives
- Pregnancy/breast feeding
- Known infertility
- Known former or actual hormonal disorder
- Polycystic ovarial syndrom (PCOS)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood sample and ultrasoundWhen included in the study blood samples and ultrasound are taken every second day of the first and third menstrual cycle after inclusion. | Procedure or surgery | Group 1, Group 2 |
Primary outcome
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
1 secondary outcome
number of ovarian follicles as made visible by 3D ultrasound
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
- Derived from this study: PubMed 34717057Biniasch 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian De Geyter, Prof. principal investigator
USB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Failure, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
between cycle reliability of ovarian reserve assessment based on AMH serum concentration (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03398603, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2020.