Reproductive SterilityAMHNCT06330259
Does the AMH Concentration Depend on the Menstrual Cycle?
An observational study of Reproductive Sterility, run by University of Basel at 1 site in Switzerland.
Trial summary
During two none subsequent natural menstrual cycles healthy female participants will be subjected every second day to blood sampling and 3D-ultrasound examinations. Together with four other key hormones the concentration of AMH (anti-Muellerian Hormone) will be measured in the serum. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Reproductive Sterility
- What is being tested?
- menstrual cycle monitoring
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jul 2017to 31 Dec 2019
- 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 39 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: healthy female women with regular menstrual cycles.
Who may be able to join
- regular menstrual cycles, between 24 and 32 d.
- body mass index between 24 and 32 kg/m2
- no HIV, no Hepatitis B and C
- no smoking
Who cannot join
- intake of reproductive hormones, including birth control pill
- pregnancy or breastfeeding
- infertility
- polycystic ovary syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ist Die Konzentration Des Anti-Müllerschen Hormons (AMH) abhängig Vom Menstruationszyklus?
During two none subsequent natural menstrual cycles healthy female participants will be subjected every second day to blood sampling and 3D-ultrasound examinations. Together with four other key hormones the concentration of AMH (anti-Muellerian Hormone) will be measured in the serum.
Read the detailed description
During two none subsequent natural menstrual cycles healthy female participants will be subjected every second day to blood sampling and 3D-ultrasound examinations. Together with four other key hormones the concentration of AMH will be measured in the serum. Half of the serum samples will immediately be subjected to hormone analysis whereas the other half will be stored frozen at -80 °C. After conclusion of the study the frozen samples will be subjected to re-measurment again a reference laboratory. The aim is to study the stability of the AMH Elecsys Assay under both conditions. The participants will be health women aged between 18 and 40 years. They will be grouped into a younger and an older group. They will be observed during one menstrual cycle, then they will remain unobserved during a second menstrual cycle, and then again they will be observed during a third menstrual cycle.
- Conditions
- Reproductive Sterility
- Being tested
- menstrual cycle monitoring
- Keywords
- natural menstrual cycle, AMH, 3D ultrasound
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
menstrual cycle monitoringDiagnostic test
frequent serum sampling and 3D ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Group A | 25 younger women, aged 18 to 25 y. Receives: Diagnostic Test: menstrual cycle monitoring | |
| Group B | 25 less young women, aged 26 to 39 y. Receives: Diagnostic Test: menstrual cycle monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
AMH Elecsys Assay
The anti-Muellerian Hormone (AMH) is a heterodimer. As such, it is unstable. The newly developed assay is considered to account for this inherent instability of the hormone and is thought to produce more consistent results.
Measured: 3 months
Secondary outcomes (2)
Effect of handling of the serum on measured AMH concentrations
Handling of the serum samples may impact measured levels. The serum levels will be measured as part of daily routine both on the day of the sampling and in frozen samples (in batches, under maximal care conditions) the stability of observed serum values during the menstrual cycle
Measured: 3 months
3D ultrasound of both ovaries
Fluctuations in the number of antral follicles during the menstrual cycle.
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 posted26 Mar 2024
- Study start1 Jul 2017
- Primary completion30 Jun 2018
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reproductive SterilityStudies of the same condition, open and under way.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Basel
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Diagnostics GmbH
- Responsible party
- Principal investigator, Christian De Geyter, University of Basel
- Investigators
- Christian De Geyter, MD, Principal investigator, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06330259
- Sponsor's protocol ID
- new AMH assay
- Acronym
- AMH
- Status last verified
- Mar 2024
- First submitted
- 19 Mar 2024
- Last updated
- 1 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ist Die Konzentration Des Anti-Müllerschen Hormons (AMH) abhängig Vom Menstruationszyklus?
- ClinicalTrials.gov ID
- NCT06330259
- Acronym / sponsor ID
- AMH / new AMH assay
- Conditions
- Reproductive Sterility
- Keywords
- natural menstrual cycle, AMH, 3D ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of BaselUniversity, hospital or other
- Collaborators
- Roche Diagnostics GmbH
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 26 Mar 2024 (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.
During two none subsequent natural menstrual cycles healthy female participants will be subjected every second day to blood sampling and 3D-ultrasound examinations. Together with four other key hormones the concentration of AMH (anti-Muellerian Hormone) will be measured in the serum.
Detailed description
During two none subsequent natural menstrual cycles healthy female participants will be subjected every second day to blood sampling and 3D-ultrasound examinations. Together with four other key hormones the concentration of AMH will be measured in the serum. Half of the serum samples will immediately be subjected to hormone analysis whereas the other half will be stored frozen at -80 °C. After conclusion of the study the frozen samples will be subjected to re-measurment again a reference laboratory. The aim is to study the stability of the AMH Elecsys Assay under both conditions. The participants will be health women aged between 18 and 40 years. They will be grouped into a younger and an older group. They will be observed during one menstrual cycle, then they will remain unobserved during a second menstrual cycle, and then again they will be observed during a third menstrual cycle.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Diagnostic Test: menstrual cycle monitoring25 younger women, aged 18 to 25 y. |
| Group B | – | Diagnostic Test: menstrual cycle monitoring25 less young women, aged 26 to 39 y. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- healthy female women with regular menstrual cycles.
Key inclusion criteria (4 listed)
- regular menstrual cycles, between 24 and 32 d.
- body mass index between 24 and 32 kg/m2
- no HIV, no Hepatitis B and C
- no smoking
Key exclusion criteria (4 listed)
- intake of reproductive hormones, including birth control pill
- pregnancy or breastfeeding
- infertility
- polycystic ovary syndrome
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 |
|---|---|---|
| menstrual cycle monitoringfrequent serum sampling and 3D ultrasound | Diagnostic test | Group A, Group B |
Primary outcome
AMH Elecsys Assay
Time frame: 3 months
The anti-Muellerian Hormone (AMH) is a heterodimer. As such, it is unstable. The newly developed assay is considered to account for this inherent instability of the hormone and is thought to produce more consistent results.
2 secondary outcomes
Effect of handling of the serum on measured AMH concentrations
Time frame: 3 months
3D ultrasound of both ovaries
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 1 Apr 2024.
- 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, MD principal investigator
University of Basel
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 Reproductive Sterility, run by University of Basel 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 4 inclusion and 4 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 1 Apr 2024. 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?
AMH Elecsys Assay (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2024.