Does the AMH Concentration Depend on the Menstrual Cycle?

Reproductive Sterility Clinical Trial

— AMH  

Official title:

Ist Die Konzentration Des Anti-Müllerschen Hormons (AMH) abhängig Vom Menstruationszyklus?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06330259
• Other study ID #: new AMH assay
• Status: Completed
• Start date: July 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2024
• Source: University of Basel
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 31, 2019
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Reproductive Sterility

Intervention

Diagnostic Test:
• menstrual cycle monitoring
frequent serum sampling and 3D ultrasound

Locations

Country	Name	City	State
Switzerland	Christian De Geyter	Basel

Sponsors (2)

Lead Sponsor	Collaborator
University of Basel	Roche Diagnostics

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months
Secondary	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	3 months
Secondary	3D ultrasound of both ovaries	Fluctuations in the number of antral follicles during the menstrual cycle.	3 months