Is the Concentration of Anti-Muellerian Hormon (AMH) Depe... | NCT03398603

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

NCT03398603

Sponsor

University Hospital, Basel, Switzerland

Status

Completed

Last Update Posted

Jan 28, 2020Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Ovarian Failure

Interventions

blood sample and ultrasound

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2016Actual

Primary Completion Date

Aug 31, 2018Actual

Completion Date

Oct 13, 2019Actual

First Submitted Date

Dec 26, 2017

First Submission Date that Met QC Criteria

Jan 7, 2018

First Posted Date

Jan 12, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 25, 2020

Last Update Posted Date

Jan 28, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Christian De Geyter, Professor, University Hospital, Basel, SwitzerlandPrincipal Investigator

Lead Sponsor

University Hospital, Basel, SwitzerlandOTHER

Collaborators

Name	Class
Roche Diagnostic Ltd.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

An important requirement for the use of the new measurement to determine the AMH concentration is the stability of the AMH level over the menstrual cycle. So far the unbiased AMH concentration is the most important argument to manage this parameter.

There are several studies, which give different professional opinions of the AMH concentration depending on the phase of the menstrual cycle. Some authors came to the conclusion that the AMH concentration over the menstrual cycle is constant, others described significant fluctuations. It is unclear, if the described fluctuation is relevant for the interpretation of the ovarian reserve. Recently it could be shown, that intraindividual fluctuations of joung women during the menstrual cycle is stronger, which means that the measurement of AMH in this age is less secure.

The primary goal of the study is to evaluate, if the new AMH measurement with the ElecSys method delivers stable values over the menstrual cycle.

The secondary goal of the study is to determine whether there are any fluctuations in the number of antral follicles as given by 3D ultrasound.

For this reason we are recruiting a group of 50 women within two categories of age to measure eventually changes in AMH- concentration during their menstrual cycle.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
number of ovarian follicles as made visible by 3D ultrasound	Fluctuations of antral follicle count during different menstrual cycles	3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

50 healthy female probands

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christian De Geyter, Prof.	USB	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinik für Gyn. Endokrinologie und Reproduktionsmedizin der Frauenklinik des Universitätsspitals		Basel		4031	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34717057	Derived	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.

ID	Term
D001800	Blood Specimen Collection
D019220	High-Energy Shock Waves

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis