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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03106272
Other study ID # 1611-ABU-083-HF
Secondary ID
Status Completed
Phase N/A
First received April 3, 2017
Last updated February 27, 2018
Start date April 13, 2017
Est. completion date January 15, 2018

Study information

Verified date July 2017
Source IVI Middle East Fertility Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date January 15, 2018
Est. primary completion date December 30, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 37 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms

  • Anti-Mullerian Hormone Resistance

Locations

Country Name City State
United Arab Emirates IVI Middle East Fertilty Clinic Abu Dhabi

Sponsors (1)

Lead Sponsor Collaborator
IVI Middle East Fertility Clinic

Country where clinical trial is conducted

United Arab Emirates, 

References & Publications (14)

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 antimüllerian 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. — View Citation

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. — View Citation

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

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. Review. — View Citation

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. Epub 2006 Aug 21. — View Citation

Lambert-Messerlian G, Plante B, Eklund EE, Raker C, Moore RG. Levels of antimüllerian 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. — View Citation

Overbeek A, Broekmans FJ, Hehenkamp WJ, Wijdeveld ME, van Disseldorp J, van Dulmen-den Broeder E, Lambalk CB. Intra-cycle fluctuations of anti-Müllerian 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. — View Citation

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

Seifer DB, Maclaughlin DT. Mullerian Inhibiting Substance is an ovarian growth factor of emerging clinical significance. Fertil Steril. 2007 Sep;88(3):539-46. Epub 2007 Jun 7. Review. — View Citation

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

Streuli I, Fraisse T, Pillet C, Ibecheole V, Bischof P, de Ziegler D. Serum antimüllerian 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. Epub 2007 Oct 24. — View Citation

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

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. — View Citation

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. — View Citation

* Note: There are 14 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary AMH serum levels dynamic In order to describe each hormone and its dynamics, will determine mean and standard deviations in each time and it will be represented with boxplot figures.
Moreover,the investigator will define polynomial interpolation for dynamic values and each hormone will be represented with mean polynomial interpolation and variance band
9months
Secondary Inter-cycle AMH variations inter-cycle variability of AMH across two cycles is concluded independently that AMH varies a little between cycles. 9months