Anti-Mullerian Hormone ResistanceNCT03106272

Evaluating the AMH Levels During Natural Cycle

An observational study of Anti-Mullerian Hormone Resistance, run by ART Fertility Clinics LLC at 1 site in United Arab Emirates.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To describe AMH serum levels dynamics during natural cycle using an automated assay. Read more about this study

Who is it for?: Ages 18 to 37 years, women onlyHealthy volunteers can take part
Conditions the study is for: Anti-Mullerian Hormone Resistance
How many people: 20 participants
Where: 1 siteUnited Arab Emirates
Study dates: 13 Apr 2017to 15 Jan 2018
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 37 years
Women only
Healthy volunteers accepted
Adult

Study population: Healthy women with regular menstrual cycles.

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United Arab Emirates1 site

IVI Middle East Fertilty Clinic
Abu Dhabi

Other trials in United Arab Emirates

About this study

Official title: Anti-Mullerian Hormone Dynamics During Natural Cycle Using Automated Assay

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

Read the detailed 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.

Conditions: Anti-Mullerian Hormone Resistance

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 9months

Secondary outcomes (1)

Inter-cycle AMH variations
inter-cycle variability of AMH across two cycles is concluded independently that AMH varies a little between cycles.
Measured: 9months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Apr 201715 Jan 2018

First posted10 Apr 2017
Study start13 Apr 2017
Primary completion30 Dec 2017
Study completion15 Jan 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for Anti-Mullerian Hormone ResistanceStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03106272
Sponsor's protocol ID: 1611-ABU-083-HF
Status last verified: Jul 2017
First submitted: 3 Apr 2017
Last updated: 28 Feb 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

Publications

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.
PubMed 25681853
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.
PubMed 20097333
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.
PubMed 16804046
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.
PubMed 24348558
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.
PubMed 16923748
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.
PubMed 26477497
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.
PubMed 22503280
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.
PubMed 24423305
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.
PubMed 17559842
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.
PubMed 19969291
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.
PubMed 17919608
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.
PubMed 17485437
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.
PubMed 19840990
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.
PubMed 12620425

Study at a glance

From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Anti-Mullerian Hormone Dynamics During Natural Cycle Using Automated Assay
ClinicalTrials.gov ID: NCT03106272
Acronym / sponsor ID: 1611-ABU-083-HF
Conditions: Anti-Mullerian Hormone Resistance
Study type: Observational
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: ART Fertility Clinics LLCUniversity, hospital or other
Study start: 13 Apr 2017 (actual)
Primary completion: 30 Dec 2017 (actual)
Study completion: 15 Jan 2018 (actual)
First posted: 10 Apr 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed 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.

Study design

Observational model: Case only
Time perspective: Prospective

Who may qualify

Ages: 18 to 37 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult
Study population: Healthy women with regular menstrual cycles.

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

AMH serum levels dynamic
Time frame: 9months
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

1 secondary outcome

Inter-cycle AMH variations
Time frame: 9months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
Background: PubMed 25681853Anderson 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.
Background: PubMed 20097333Fatemi 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.
Background: PubMed 16804046Hehenkamp 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.
Background: PubMed 24348558La 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.
Background: PubMed 16923748La 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.
Background: PubMed 26477497Lambert-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.
Background: PubMed 22503280Overbeek 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.
Background: PubMed 24423305Rustamov 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.
Background: PubMed 17559842Seifer 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.
Background: PubMed 19969291Sowers 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.
Background: PubMed 17919608Streuli 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.
Background: PubMed 17485437Tsepelidis 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.
Individual participant dataSharing planned: Yes

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Human Fatemi, Medical D. principal investigator

IVI Middle East Fertility Clinic LLC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Anti-Mullerian Hormone Resistance, run by ART Fertility Clinics LLC at 1 site in United Arab Emirates.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AMH serum levels dynamic (time frame: 9months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03106272, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2018.