Skip to main content
OpenTrials
Completed

NCT Number: NCT03826888

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anti-Mullerian Hormone Isoforms

Sex eligibility

Female

Study type

Observational

Primary location

IVI Middle East Fertility Clinic

Abu Dhabi, 60202, United Arab Emirates

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Inhibin B and ovarian reserve markers

    Time frame: 1 day

    Correlation between Inhibin B and ovarian reserve markers (AMH serum levels and AFC)

  2. AMH serum and AFC

    Time frame: 1 day

    Correlation between AMH serum levels (measured with different ELISA tests) and AFC.

Sponsors and collaborators

Lead sponsor

ART Fertility Clinics LLC

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Feb 1, 2019
Registry last updated
Aug 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.