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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anti-Mullerian Hormone Isoforms

Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IVF, AMH isoforms, ovarian reserve test, poor response