Measurement of Different Anti-Müllerian Hormone Isoforms in Expected Poor Responders
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|ClinicalTrials.gov Identifier: NCT03826888|
Recruitment Status : Recruiting
First Posted : February 1, 2019
Last Update Posted : September 6, 2019
|Condition or disease|
|Anti-Mullerian Hormone Isoforms|
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|
|Estimated Enrollment :||120 participants|
|Official Title:||Measurement of Different Anti-Müllerian Hormone Isoforms in Expected Poor Responders: Does it Matter?|
|Actual Study Start Date :||February 25, 2019|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||July 2020|
- 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.
- Inhibin B and ovarian reserve markers [ Time Frame: 1 day ]Correlation between Inhibin B and ovarian reserve markers (AMH serum levels and AFC)
- AMH serum and AFC [ Time Frame: 1 day ]Correlation between AMH serum levels (measured with different ELISA tests) and AFC.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03826888
|Contact: Laura Melado||026528000 ext firstname.lastname@example.org|
|Contact: Shieryl Digma||026528000 ext email@example.com|
|United Arab Emirates|
|IVI Middle East Fertility Clinic||Recruiting|
|Abu Dhabi, United Arab Emirates, 60202|
|Contact: Barbara Lawrenz +97102 652 8000 firstname.lastname@example.org|
|Principal Investigator: Laura Melado|