Measurement of Different Anti-Müllerian Hormone Isoforms in Expected Poor Responders

August 4, 2022 updated by: Laura Melado, ART Fertility Clinics LLC

Measurement of Different Anti-Müllerian Hormone Isoforms in Expected Poor Responders: Does it Matter?

This study wants to evaluate significant clinical impact of different AMH isoforms in serum can be present or absent in expected poor responder participants. The specific AMH isoforms could therefore be measured in expected poor responder participants in order to obtain a more realistic clinical picture and therefore be able to give proper information to the participants and selection of medication dose for ovarian stimulation.

Study Overview

Status

Completed

Conditions

Detailed Description

The study has a prospective observational multicentric design and the investigators aim to investigate the presence of AMH isoforms and the levels of Inhibin B in serum among a population of participants with low ovarian reserve (AMH blood test below 1.1 ng/ml). Transvaginal scan for AFC and blood drawn from participants will be obtained on day 2-3 of menstrual period. The serum will be divided for AMH analysis using different assays: Elecsys Cobas assay for AMH and AnshLabs AMH isoforms specific assays (picoAMH 24/32 Pro-Mature, 24/37 Midpro-Midpro, 17/15 Mature-Mature and 10/24 Pro-Midpro) and AnshLabs Inhibin B ELISA.

Clinically it is not uncommon to see a discrepancy between the AFC count and the levels of AMH; this could be potentially explained by the presence of different AMH isoforms not measured with conventional commercial assays. Also, the evaluation of Inhibin B may be helpful for ovarian reserve assessment. Quantitation of specific Isoforms of AMH by different ELISA methods will investigate a possible relationship(s) between specific isoforms of AMH and poor responders.

Study Type

Observational

Enrollment (Actual)

72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Infertile female undergoing ovarian stimulation

Description

Inclusion Criteria:

  • pre-treatment AMH recording below 1.1 ng/ml on day 2 or 3 of the menstrual cycle.
  • BMI between 18 and 30 kg/m2.

Exclusion Criteria:

  • Pregnancy.
  • Breastfeeding.
  • Intake of oral contraceptive pills or steroids for the last two menstrual cycles.
  • Endometriosis.
  • Previous surgical intervention, which could have an impact on the ovarian reserve, e.g. ovarian cyst removal, removal of one or both tubes, tubal ligation for sterilisation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AMH serum levels
Time Frame: 1 day
Differences in AMH serum levels due to the presence of different AMH isoforms when results are compared with AMH measurement in blood performed with Elecsys Cobas AMH assay.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inhibin B and ovarian reserve markers
Time Frame: 1 day
Correlation between Inhibin B and ovarian reserve markers (AMH serum levels and AFC)
1 day
AMH serum and AFC
Time Frame: 1 day
Correlation between AMH serum levels (measured with different ELISA tests) and AFC.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ART Fertility Clinics LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2019

Primary Completion (Actual)

December 23, 2021

Study Completion (Actual)

May 30, 2022

Study Registration Dates

First Submitted

January 30, 2019

First Submitted That Met QC Criteria

January 30, 2019

First Posted (Actual)

February 1, 2019

Study Record Updates

Last Update Posted (Actual)

August 8, 2022

Last Update Submitted That Met QC Criteria

August 4, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1807-ABU-055-LM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anti-Mullerian Hormone Isoforms

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe