Does the AMH Concentration Depend on the Menstrual Cycle?

University of Basel50 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Reproductive Sterility

Interventions

menstrual cycle monitoringDIAGNOSTIC_TEST

frequent serum sampling and 3D ultrasound

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 39 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Christian De Geyter

Basel, Switzerland

Outcomes

Primary Outcomes

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.

Time frame: 3 months

Secondary Outcomes

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

Time frame: 3 months

3D ultrasound of both ovaries

Fluctuations in the number of antral follicles during the menstrual cycle.

Time frame: 3 months

Data from ClinicalTrials.gov

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