Measurement of Different Anti-Müllerian Hormone Isoforms in Expected Poor Responders
NCT ID: NCT03826888
Last Updated: 2022-08-08
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Total Enrollment
72 participants
Study Classification
OBSERVATIONAL
Study Start Date
2019-02-25
Study Completion Date
2022-05-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Clinical Performance Evaluation of AMH Assay
NCT03131388
Anti-Mullerian Hormone
COMPLETED
Anti-Mullerian Hormone - At My Home
NCT04784325
Fertility Risk
COMPLETED
NA
The Effect of Birth Control Methods on Anti-Mullerian Hormone (AMH) Levels
NCT01308931
Birth Control
WITHDRAWN
Blood Spot Self-administered Test and Assay
NCT03840824
Dysfunction; Endocrine
Effects of Chemotherapy
Premature Ovarian Failure
COMPLETED
Open-Label Study to Evaluate the Safety and Efficacy of a Low-Dose 28-Day Oral Contraceptive
NCT00362479
Contraception
COMPLETED
PHASE3
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Anti-Mullerian Hormone Isoforms
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Observational Model Type
CASE_ONLY
Study Time Perspective
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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.
* 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
* 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
Eligible Sex
FEMALE
Accepts Healthy Volunteers
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
ART Fertility Clinics LLC
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Laura Melado
IVF Specialist
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
IVI Middle East Fertility Clinic
Abu Dhabi, , United Arab Emirates
Site Status
Countries
Review the countries where the study has at least one active or historical site.
United Arab Emirates
References
Explore related publications, articles, or registry entries linked to this study.
McLennan IS, Pankhurst MW. Anti-Mullerian hormone is a gonadal cytokine with two circulating forms and cryptic actions. J Endocrinol. 2015 Sep;226(3):R45-57. doi: 10.1530/JOE-15-0206. Epub 2015 Jul 10.
Reference Type
BACKGROUND
Cate RL, Mattaliano RJ, Hession C, Tizard R, Farber NM, Cheung A, Ninfa EG, Frey AZ, Gash DJ, Chow EP, et al. Isolation of the bovine and human genes for Mullerian inhibiting substance and expression of the human gene in animal cells. Cell. 1986 Jun 6;45(5):685-98. doi: 10.1016/0092-8674(86)90783-x.
Reference Type
BACKGROUND
Josso N, Belville C, di Clemente N, Picard JY. AMH and AMH receptor defects in persistent Mullerian duct syndrome. Hum Reprod Update. 2005 Jul-Aug;11(4):351-6. doi: 10.1093/humupd/dmi014. Epub 2005 May 5.
Reference Type
BACKGROUND
Pankhurst MW, McLennan IS. Human blood contains both the uncleaved precursor of anti-Mullerian hormone and a complex of the NH2- and COOH-terminal peptides. Am J Physiol Endocrinol Metab. 2013 Nov 15;305(10):E1241-7. doi: 10.1152/ajpendo.00395.2013. Epub 2013 Sep 17.
Reference Type
BACKGROUND
Pankhurst MW, Chong YH, McLennan IS. Enzyme-linked immunosorbent assay measurements of antimullerian hormone (AMH) in human blood are a composite of the uncleaved and bioactive cleaved forms of AMH. Fertil Steril. 2014 Mar;101(3):846-50. doi: 10.1016/j.fertnstert.2013.12.009. Epub 2014 Jan 11.
Reference Type
BACKGROUND
Pankhurst MW, Clark CA, Zarek J, Laskin CA, McLennan IS. Changes in Circulating ProAMH and Total AMH during Healthy Pregnancy and Post-Partum: A Longitudinal Study. PLoS One. 2016 Sep 9;11(9):e0162509. doi: 10.1371/journal.pone.0162509. eCollection 2016.
Reference Type
BACKGROUND
Robertson DM, Kumar A, Kalra B, Shah S, Pruysers E, Vanden Brink H, Chizen D, Visser JA, Themmen AP, Baerwald A. Detection of serum antimullerian hormone in women approaching menopause using sensitive antimullerian hormone enzyme-linked immunosorbent assays. Menopause. 2014 Dec;21(12):1277-86. doi: 10.1097/GME.0000000000000244.
Reference Type
BACKGROUND
Robertson DM, Hale GE, Fraser IS, Hughes CL, Burger HG. Changes in serum antimullerian hormone levels across the ovulatory menstrual cycle in late reproductive age. Menopause. 2011 May;18(5):521-4. doi: 10.1097/gme.0b013e3181f8d9e0.
Reference Type
BACKGROUND
Gnoth C, Schuring AN, Friol K, Tigges J, Mallmann P, Godehardt E. Relevance of anti-Mullerian hormone measurement in a routine IVF program. Hum Reprod. 2008 Jun;23(6):1359-65. doi: 10.1093/humrep/den108. Epub 2008 Apr 2.
Reference Type
BACKGROUND
Ferraretti AP, La Marca A, Fauser BC, Tarlatzis B, Nargund G, Gianaroli L; ESHRE working group on Poor Ovarian Response Definition. ESHRE consensus on the definition of 'poor response' to ovarian stimulation for in vitro fertilization: the Bologna criteria. Hum Reprod. 2011 Jul;26(7):1616-24. doi: 10.1093/humrep/der092. Epub 2011 Apr 19.
Reference Type
BACKGROUND
Kedem A, Haas J, Geva LL, Yerushalmi G, Gilboa Y, Kanety H, Hanochi M, Maman E, Hourvitz A. Ongoing pregnancy rates in women with low and extremely low AMH levels. A multivariate analysis of 769 cycles. PLoS One. 2013 Dec 16;8(12):e81629. doi: 10.1371/journal.pone.0081629. eCollection 2013.
Reference Type
BACKGROUND
Koshy AK, Gudi A, Shah A, Bhide P, Timms P, Homburg R. Pregnancy prognosis in women with anti-Mullerian hormone below the tenth percentile. Gynecol Endocrinol. 2013 Jul;29(7):662-5. doi: 10.3109/09513590.2013.797395.
Reference Type
BACKGROUND
Seifer DB, Tal O, Wantman E, Edul P, Baker VL. Prognostic indicators of assisted reproduction technology outcomes of cycles with ultralow serum antimullerian hormone: a multivariate analysis of over 5,000 autologous cycles from the Society for Assisted Reproductive Technology Clinic Outcome Reporting System database for 2012-2013. Fertil Steril. 2016 Feb;105(2):385-93.e3. doi: 10.1016/j.fertnstert.2015.10.004. Epub 2015 Oct 26.
Reference Type
BACKGROUND
Broekmans FJ, de Ziegler D, Howles CM, Gougeon A, Trew G, Olivennes F. The antral follicle count: practical recommendations for better standardization. Fertil Steril. 2010 Aug;94(3):1044-51. doi: 10.1016/j.fertnstert.2009.04.040. Epub 2009 Jul 8.
Reference Type
BACKGROUND
Melado L, Kumar A, Kalra B, Kalafat E, Lawrenz B, Fatemi H. How to enhance prediction of clinical outcomes in poor responders: integrating high-specific assays for anti-mullerian hormone with antral follicle count. Front Endocrinol (Lausanne). 2025 Sep 29;16:1654365. doi: 10.3389/fendo.2025.1654365. eCollection 2025.
Reference Type
DERIVED
Melado L, Kumar A, Kalra B, Kalafat E, Lawrenz B, Fatemi H. The role of bioavailable inhibin B in predicting oocyte yield in expected poor responders: the forgotten marker? J Assist Reprod Genet. 2025 Aug 27. doi: 10.1007/s10815-025-03637-9. Online ahead of print.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1807-ABU-055-LM
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Study Comparing Four New Formulations for Premarin in Healthy Postmenopausal Women
NCT00380887
COMPLETED
Comparative Trial in Hormone Withdrawal Associated Symptoms
NCT01076582
COMPLETED
PHASE3
Hormone Therapy in Preventing Endometrial Cancer in Patients With a Genetic Risk For Hereditary Nonpolyposis Colon Cancer
NCT00033358
COMPLETED
PHASE2
To Study The Influence Of Genomic Factors On Metabolism And Effects Of Clomiphene In Asian Normogonadotrophic Anovulatory Patients.
NCT02548039
COMPLETED
Clinical Study of a Conventional and Flexible Extended Oral Contraceptive of EE/DRSP With or Without Metafolin in Latin America
NCT01331655
WITHDRAWN
PHASE3
An Open-Label Study to Compare the Bleeding Profile of Norelgestromin/Ethinyl Estradiol in an Extended Regimen to Norelgestromin/Ethinyl Estradiol Given in a Traditional Regimen
NCT00320580
COMPLETED
PHASE2
A Study to Evaluate Ovarian Follicular Activity and Hormone Levels for DR-102 Compared to Two 28-Day Oral Contraceptives
NCT01291004
COMPLETED
PHASE1
"E4/DRSP Endocrine Function, Metabolic Control and Hemostasis Study"
NCT02957630
COMPLETED
PHASE1/PHASE2
Open-label Study to Evaluate the Efficacy and Safety of an Extended-cycle, Low Dose Combination Oral Contraceptive
NCT00196326
COMPLETED
PHASE3
Premenstrual Symptoms Treatment Comparing Between Oral Contraceptives Containing Desogestrel and Drospirenone
NCT01482338
COMPLETED
PHASE4
Pharmacodynamics and Pharmacokinetics Study of Existing DMPA Contraceptive Methods
NCT02456584
COMPLETED
PHASE1
Effect of Oestrogen on Musculoskeletal Outcomes
NCT05587920
UNKNOWN
MPA Versus Dydrogesterone for Management of Endometrial Hyperplasia Without Atypia
NCT03675139
COMPLETED
PHASE3
Assessing Ovarian Function During Prolonged Implant Use
NCT03058978
COMPLETED
A Study to Investigate the Effects of BMS-986278 on Drospirenone and Ethinyl Estradiol Drug Levels in Healthy Female Participants
NCT05985590
COMPLETED
PHASE1
Pharmacokinetics and Pharmacodynamics of DMPA With HIV PrEP
NCT03197961
COMPLETED
EARLY_PHASE1
Oral Contraceptives and Subantimicrobial Doxycycline: Effect on Endometrial Matrix Metalloproteinases
NCT01469585
COMPLETED
NA
Study Comparing Bioavailability of 3 New Formulations of Premarin/MPA With Premarin/MPA (PREMPRO) Reference Formulation
NCT00401219
COMPLETED
PHASE1
A Study to Evaluate Hormone Patterns and Ovarian Follicular Activity With DR-1021
NCT00544882
COMPLETED
PHASE3
Self Administration of Subcutaneous Depot Medroxyprogesterone Acetate
NCT00770887
COMPLETED
Efficacy and Safety Study for an Oral Contraceptive Containing Folate
NCT00468481
COMPLETED
PHASE3
Study of Safety and Efficacy of an Oral Contraceptive
NCT00391807
COMPLETED
PHASE3
Assessing the Effect of Multiple Doses of Zibotentan on the Pharmacokinetics of Single Doses of Combined Oral Contraceptives in Healthy Female Participants of Non-childbearing Potential.
NCT05505162
COMPLETED
PHASE1
AG200-15 Transdermal Contraceptive Delivery System (TCDS) of Levonorgestrel and Ethinyl Estradiol
NCT01243580
COMPLETED
PHASE1