Evaluating the AMH Levels During Natural Cycle

NCT ID: NCT03106272

Last Updated: 2018-02-28

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

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-13

Study Completion Date

2018-01-15

Brief Summary

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To describe AMH serum levels dynamics during natural cycle using an automated assay.

Detailed Description

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The potential benefit would be using an automated assay for AMH, the dynamics of serum levels during the natural cycle and to check the inter-cycle variations.

Because of the many clinical decisions that are based on AMH levels alone the results of this study could bring reassurance to the continuous use of AMH in daily practice. More importantly, no studies to date have been performed on the newer automated assays evaluating variability of AMH levels.

Conditions

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Anti-Mullerian Hormone Resistance

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Women with written informed consent.
* Women between ≥ 18 and ≤ 37 years of age.
* BMI between 18 and 28.
* Normal physical examination and pelvic exam.

Exclusion Criteria

* Pregnancy.
* Breastfeeding.
* History of any disease/iatrogenic intervention which could have had an impact on the ovarian reserve (e.g. ovarian surgery, chemotherapy, radiation of the pelvis, endometriosis)
* Intake of OCP for the two last menstrual cycles.
Minimum Eligible Age

18 Years

Maximum Eligible Age

37 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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ART Fertility Clinics LLC

OTHER

Sponsor Role lead

Responsible Party

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Prof Dr. Human Fatemi

Medical Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Human Fatemi, Medical D.

Role: PRINCIPAL_INVESTIGATOR

IVI Middle East Fertility Clinic LLC

Locations

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IVI Middle East Fertilty Clinic

Abu Dhabi, , United Arab Emirates

Site Status

Countries

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United Arab Emirates

References

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Anderson RA, Anckaert E, Bosch E, Dewailly D, Dunlop CE, Fehr D, Nardo L, Smitz J, Tremellen K, Denk B, Geistanger A, Hund M. Prospective study into the value of the automated Elecsys antimullerian hormone assay for the assessment of the ovarian growing follicle pool. Fertil Steril. 2015 Apr;103(4):1074-1080.e4. doi: 10.1016/j.fertnstert.2015.01.004. Epub 2015 Feb 11.

Reference Type BACKGROUND
PMID: 25681853 (View on PubMed)

Fatemi HM, Kyrou D, Bourgain C, Van den Abbeel E, Griesinger G, Devroey P. Cryopreserved-thawed human embryo transfer: spontaneous natural cycle is superior to human chorionic gonadotropin-induced natural cycle. Fertil Steril. 2010 Nov;94(6):2054-8. doi: 10.1016/j.fertnstert.2009.11.036. Epub 2010 Jan 25.

Reference Type BACKGROUND
PMID: 20097333 (View on PubMed)

Hehenkamp WJ, Looman CW, Themmen AP, de Jong FH, Te Velde ER, Broekmans FJ. Anti-Mullerian hormone levels in the spontaneous menstrual cycle do not show substantial fluctuation. J Clin Endocrinol Metab. 2006 Oct;91(10):4057-63. doi: 10.1210/jc.2006-0331. Epub 2006 Jun 27.

Reference Type BACKGROUND
PMID: 16804046 (View on PubMed)

La Marca A, Grisendi V, Griesinger G. How Much Does AMH Really Vary in Normal Women? Int J Endocrinol. 2013;2013:959487. doi: 10.1155/2013/959487. Epub 2013 Nov 19.

Reference Type BACKGROUND
PMID: 24348558 (View on PubMed)

La Marca A, Stabile G, Artenisio AC, Volpe A. Serum anti-Mullerian hormone throughout the human menstrual cycle. Hum Reprod. 2006 Dec;21(12):3103-7. doi: 10.1093/humrep/del291. Epub 2006 Aug 21.

Reference Type BACKGROUND
PMID: 16923748 (View on PubMed)

Lambert-Messerlian G, Plante B, Eklund EE, Raker C, Moore RG. Levels of antimullerian hormone in serum during the normal menstrual cycle. Fertil Steril. 2016 Jan;105(1):208-13.e1. doi: 10.1016/j.fertnstert.2015.09.033. Epub 2015 Oct 23.

Reference Type BACKGROUND
PMID: 26477497 (View on PubMed)

Overbeek A, Broekmans FJ, Hehenkamp WJ, Wijdeveld ME, van Disseldorp J, van Dulmen-den Broeder E, Lambalk CB. Intra-cycle fluctuations of anti-Mullerian hormone in normal women with a regular cycle: a re-analysis. Reprod Biomed Online. 2012 Jun;24(6):664-9. doi: 10.1016/j.rbmo.2012.02.023. Epub 2012 Mar 9.

Reference Type BACKGROUND
PMID: 22503280 (View on PubMed)

Rustamov O, Smith A, Roberts SA, Yates AP, Fitzgerald C, Krishnan M, Nardo LG, Pemberton PW. The measurement of anti-Mullerian hormone: a critical appraisal. J Clin Endocrinol Metab. 2014 Mar;99(3):723-32. doi: 10.1210/jc.2013-3476. Epub 2013 Jan 1.

Reference Type BACKGROUND
PMID: 24423305 (View on PubMed)

Seifer DB, Maclaughlin DT. Mullerian Inhibiting Substance is an ovarian growth factor of emerging clinical significance. Fertil Steril. 2007 Sep;88(3):539-46. doi: 10.1016/j.fertnstert.2007.02.014. Epub 2007 Jun 7.

Reference Type BACKGROUND
PMID: 17559842 (View on PubMed)

Sowers M, McConnell D, Gast K, Zheng H, Nan B, McCarthy JD, Randolph JF. Anti-Mullerian hormone and inhibin B variability during normal menstrual cycles. Fertil Steril. 2010 Sep;94(4):1482-1486. doi: 10.1016/j.fertnstert.2009.07.1674. Epub 2009 Dec 6.

Reference Type BACKGROUND
PMID: 19969291 (View on PubMed)

Streuli I, Fraisse T, Pillet C, Ibecheole V, Bischof P, de Ziegler D. Serum antimullerian hormone levels remain stable throughout the menstrual cycle and after oral or vaginal administration of synthetic sex steroids. Fertil Steril. 2008 Aug;90(2):395-400. doi: 10.1016/j.fertnstert.2007.06.023. Epub 2007 Oct 24.

Reference Type BACKGROUND
PMID: 17919608 (View on PubMed)

Tsepelidis S, Devreker F, Demeestere I, Flahaut A, Gervy Ch, Englert Y. Stable serum levels of anti-Mullerian hormone during the menstrual cycle: a prospective study in normo-ovulatory women. Hum Reprod. 2007 Jul;22(7):1837-40. doi: 10.1093/humrep/dem101. Epub 2007 May 7.

Reference Type BACKGROUND
PMID: 17485437 (View on PubMed)

van Disseldorp J, Lambalk CB, Kwee J, Looman CW, Eijkemans MJ, Fauser BC, Broekmans FJ. Comparison of inter- and intra-cycle variability of anti-Mullerian hormone and antral follicle counts. Hum Reprod. 2010 Jan;25(1):221-7. doi: 10.1093/humrep/dep366. Epub 2009 Oct 19.

Reference Type BACKGROUND
PMID: 19840990 (View on PubMed)

van Rooij IA, Bancsi LF, Broekmans FJ, Looman CW, Habbema JD, te Velde ER. Women older than 40 years of age and those with elevated follicle-stimulating hormone levels differ in poor response rate and embryo quality in in vitro fertilization. Fertil Steril. 2003 Mar;79(3):482-8. doi: 10.1016/s0015-0282(02)04839-2.

Reference Type BACKGROUND
PMID: 12620425 (View on PubMed)

Other Identifiers

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1611-ABU-083-HF

Identifier Type: -

Identifier Source: org_study_id

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