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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03826888
Recruitment Status : Recruiting
First Posted : February 1, 2019
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
Laura Melado, IVI Middle East Fertility Clinic

Brief 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.

Condition or disease
Anti-Mullerian Hormone Isoforms

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.

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones




Primary Outcome Measures :
  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 Outcome Measures :
  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.


Biospecimen Retention:   Samples With DNA
blood specimen


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Infertile female undergoing ovarian stimulation
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Laura Melado 026528000 ext 1107 laura.melado@ivirma.com
Contact: Shieryl Digma 026528000 ext 1106 shieryl.digma@ivirma.com

Locations
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United Arab Emirates
IVI Middle East Fertility Clinic Recruiting
Abu Dhabi, United Arab Emirates, 60202
Contact: Barbara Lawrenz    +97102 652 8000    barbara.lawrenz@ivirma.com   
Principal Investigator: Laura Melado         
Sponsors and Collaborators
IVI Middle East Fertility Clinic
Publications:

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Responsible Party: Laura Melado, IVF Specialist, IVI Middle East Fertility Clinic
ClinicalTrials.gov Identifier: NCT03826888    
Other Study ID Numbers: 1807-ABU-055-LM
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Laura Melado, IVI Middle East Fertility Clinic:
IVF
AMH isoforms
ovarian reserve test
poor response