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

ART Fertility Clinics LLC

Status: Completed

Conditions: Anti-Mullerian Hormone Isoforms

Study type: Observational

Funder types: Other

Identifiers

NCT03826888

1807-ABU-055-LM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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