Is the Concentration of Anti-Muellerian Hormon (AMH) Depending on the Menstrual Cycle?

NCT03398603 | Completed

• 1 other identifier: 2016-01824
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ovarian Failure

Keywords

AMH measurement "ElecSys"

Outcome Measures

Primary Outcomes (1)

• between cycle reliability of ovarian reserve assessment based on AMH serum concentration

  stabile assessment of ovarian reserve with AMH (pmol/l) in blood

  3 months

Secondary Outcomes (1)

• number of ovarian follicles as made visible by 3D ultrasound

  3 months

Study Arms (2)

Group 1

25 women with age of 18-25 years

Procedure: blood sample and ultrasound

Group 2

25 women with age of 26-40 years

Procedure: blood sample and ultrasound

Interventions

blood sample and ultrasound PROCEDURE

When included in the study blood samples and ultrasound are taken every second day of the first and third menstrual cycle after inclusion.

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

50 healthy female probands

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Roche Diagnostic Ltd.: collaborator

Study Sites (1)

Klinik für Gyn. Endokrinologie und Reproduktionsmedizin der Frauenklinik des Universitätsspitals

Basel, 4031, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 34717057 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

For screening titer of hepatitis B/C- and HIV is measured once On every second day of two non-consecutive menstrual cycles we take encoded blood samples and measure the AMH value with the "ElecSys" method as well as the hormons LH, FSH, Estradiol und Progesterone On every second day of two non-consecutive menstrual cycles we take an encoded vaginal 3D ultrasound.

MeSH Terms

Interventions

Blood Specimen Collection; High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Christian De Geyter, Prof.

  USB

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 26, 2017
• First Posted: January 12, 2018
• Study Start: November 1, 2016
• Primary Completion: August 31, 2018
• Study Completion: October 13, 2019
• Last Updated: January 28, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)