Clinical Trials Directory

Trials / Completed

CompletedNCT03826888

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

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

Status
Completed
Phase
Study type
Observational
Enrollment
72 (actual)
Sponsor
ART Fertility Clinics LLC · Academic / Other
Sex
Female
Age
Healthy volunteers
Accepted

Summary

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.

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.

Conditions

Timeline

Start date
2019-02-25
Primary completion
2021-12-23
Completion
2022-05-30
First posted
2019-02-01
Last updated
2022-08-08

Locations

1 site across 1 country: United Arab Emirates

Source: ClinicalTrials.gov record NCT03826888. Inclusion in this directory is not an endorsement.