Reproductive Sterility
Conditions
Keywords
natural menstrual cycle, AMH, 3D ultrasound
Brief 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.
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.
Interventions
DIAGNOSTIC_TESTmenstrual cycle monitoring
frequent serum sampling and 3D ultrasound
Sponsors
Roche Diagnostics GmbH
University of Basel
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 39 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* intake of reproductive hormones, including birth control pill * pregnancy or breastfeeding * infertility * polycystic ovary syndrome
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AMH Elecsys Assay | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of handling of the serum on measured AMH concentrations | 3 months | 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 |
| 3D ultrasound of both ovaries | 3 months | Fluctuations in the number of antral follicles during the menstrual cycle. |
Countries
Switzerland
Outcome results
None listed