AMH and Dosing Regimens for Initial IVF Stimulation Protocols

NCT03098199 | Completed

• 1 other identifier: 597102-3
• Study Type: interventional
• Target: 78
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a research study on a hormone in women called anti-mullerian hormone (AMH) an indicator of the amount of egg reserve in the ovaries. The research involves a blood draw to determine the AMH level. This knowledge will help the investigators decide a dosage of gonadotropins, the hormones used to stimulate the production of more than one egg for use in an in vitro fertilization (IVF) cycle. The amount of gonadotropin given has to be tailored to each individual participant. The investigators can use information about the participant and the hormone levels to determine this dosage and the chances of becoming pregnant as a result of IVF treatment. The reason the investigators are doing this research is to find out if basing the gonadotropin dosage solely on the participant's AMH level will give the investigators a better result than the previous method based on age and other hormone levels.

Conditions

Infertility

Keywords

Antimullerian Hormone; In vitro fertilization; Medications; Dosing

Outcome Measures

Primary Outcomes (1)

• clinical pregnancy rate

  Clinical pregnancy rate is defined as the number of pregnancies with the presence of an intrauterine gestational sac seen on transvaginal ultrasound by six weeks gestation divided by the number of completed embryo transfers.

  two years

Secondary Outcomes (1)

• Oocyte yield

  two years

Study Arms (4)

AMH<1.5, 300IU Gonal-F + 150 IU Menopur

EXPERIMENTAL

dosage at 300IU Gonal-F + 150IU Menopur

Drug: 300IU Gonal-F; Drug: 150IU Menopur

AMH 1.6-2.5, 225IU Gonal-F+75IU Menopur

EXPERIMENTAL

dosage of 225IU Gonal-F + 75IU Menopur

Drug: 225IU Gonal-F; Drug: 75IU Menopur

AMH 2.6-6.9, 150IU Gonal-F+75IU Menopur

EXPERIMENTAL

start dosage of 150IU Gonal-F and 75IU Menopur

Drug: 75IU Menopur; Drug: 150IU Gonal-F

AMH >=7.0, 75IU Gonal-F+75U Menopur

EXPERIMENTAL

start dosage of 75IU Gonal-F and 75U Menopur

Drug: 75IU Menopur; Drug: 75IU Gonal-F

Interventions

300IU Gonal-F DRUG

\<1.5 AMH group

Also known as: follitropin

AMH<1.5, 300IU Gonal-F + 150 IU Menopur

150IU Menopur DRUG

\<1.5 AMH group

Also known as: menotropin

AMH<1.5, 300IU Gonal-F + 150 IU Menopur

225IU Gonal-F DRUG

1.6-2.5 AMH group

AMH 1.6-2.5, 225IU Gonal-F+75IU Menopur

75IU Menopur DRUG

1.6-2.5 AMH group 2.6-6.9 AMH group \>7.0 AMH group

AMH 1.6-2.5, 225IU Gonal-F+75IU Menopur; AMH 2.6-6.9, 150IU Gonal-F+75IU Menopur; AMH >=7.0, 75IU Gonal-F+75U Menopur

150IU Gonal-F DRUG

2.6-6.9 AMH group

AMH 2.6-6.9, 150IU Gonal-F+75IU Menopur

75IU Gonal-F DRUG

\>7.0 AMH group

AMH >=7.0, 75IU Gonal-F+75U Menopur

Eligibility Criteria

• Age: 25 Years - 43 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• first cycle of IVF with transfer of fresh embryo

You may not qualify if:

• use of non-autologous oocytes; prior diagnosis of premature ovarian failure or diminished ovarian reserve; BMI\>= 40; cryopreservation cycles; smokers; use of PGS/PGD; use of surgically retrieved sperm or patients with severe male factor; and oocyte- or embryo-banking cycles

Sponsors & Collaborators

• Reproductive Specialists of New York: lead

Related Publications (27)

• Anderson RA, Nelson SM, Wallace WH. Measuring anti-Mullerian hormone for the assessment of ovarian reserve: when and for whom is it indicated? Maturitas. 2012 Jan;71(1):28-33. doi: 10.1016/j.maturitas.2011.11.008. Epub 2011 Nov 26.

  PMID: 22119275 BACKGROUND

• de Vet A, Laven JS, de Jong FH, Themmen AP, Fauser BC. Antimullerian hormone serum levels: a putative marker for ovarian aging. Fertil Steril. 2002 Feb;77(2):357-62. doi: 10.1016/s0015-0282(01)02993-4.

  PMID: 11821097 BACKGROUND

• Freour T, Mirallie S, Colombel A, Bach-Ngohou K, Masson D, Barriere P. Anti-mullerian hormone: clinical relevance in assisted reproductive therapy. Ann Endocrinol (Paris). 2006 Dec;67(6):567-74. doi: 10.1016/s0003-4266(06)73008-6.

  PMID: 17194966 BACKGROUND

• Gleicher N, Kim A, Weghofer A, Barad DH. Toward a better understanding of functional ovarian reserve: AMH (AMHo) and FSH (FSHo) hormone ratios per retrieved oocyte. J Clin Endocrinol Metab. 2012 Mar;97(3):995-1004. doi: 10.1210/jc.2011-2403. Epub 2011 Dec 14.

  PMID: 22170712 BACKGROUND

• Jayaprakasan K, Campbell B, Hopkisson J, Johnson I, Raine-Fenning N. A prospective, comparative analysis of anti-Mullerian hormone, inhibin-B, and three-dimensional ultrasound determinants of ovarian reserve in the prediction of poor response to controlled ovarian stimulation. Fertil Steril. 2010 Feb;93(3):855-64. doi: 10.1016/j.fertnstert.2008.10.042. Epub 2008 Nov 30.

  PMID: 19046583 BACKGROUND

• Kwee J, Schats R, McDonnell J, Themmen A, de Jong F, Lambalk C. Evaluation of anti-Mullerian hormone as a test for the prediction of ovarian reserve. Fertil Steril. 2008 Sep;90(3):737-43. doi: 10.1016/j.fertnstert.2007.07.1293. Epub 2007 Oct 17.

  PMID: 17923131 BACKGROUND

• Panchal S, Nagori C. Comparison of anti-mullerian hormone and antral follicle count for assessment of ovarian reserve. J Hum Reprod Sci. 2012 Sep;5(3):274-8. doi: 10.4103/0974-1208.106340.

  PMID: 23531919 BACKGROUND

• Tremellen KP, Kolo M, Gilmore A, Lekamge DN. Anti-mullerian hormone as a marker of ovarian reserve. Aust N Z J Obstet Gynaecol. 2005 Feb;45(1):20-4. doi: 10.1111/j.1479-828X.2005.00332.x.

  PMID: 15730360 BACKGROUND

• van Rooij IA, Broekmans FJ, te Velde ER, Fauser BC, Bancsi LF, de Jong FH, Themmen AP. Serum anti-Mullerian hormone levels: a novel measure of ovarian reserve. Hum Reprod. 2002 Dec;17(12):3065-71. doi: 10.1093/humrep/17.12.3065.

  PMID: 12456604 BACKGROUND

• Biasoni V, Patriarca A, Dalmasso P, Bertagna A, Manieri C, Benedetto C, Revelli A. Ovarian sensitivity index is strongly related to circulating AMH and may be used to predict ovarian response to exogenous gonadotropins in IVF. Reprod Biol Endocrinol. 2011 Aug 9;9:112. doi: 10.1186/1477-7827-9-112.

  PMID: 21824441 BACKGROUND

• Choi MH, Yoo JH, Kim HO, Cha SH, Park CW, Yang KM, Song IO, Koong MK, Kang IS. Serum anti-Mullerian hormone levels as a predictor of the ovarian response and IVF outcomes. Clin Exp Reprod Med. 2011 Sep;38(3):153-8. doi: 10.5653/cerm.2011.38.3.153. Epub 2011 Sep 30.

  PMID: 22384435 BACKGROUND

• Elgindy EA, El-Haieg DO, El-Sebaey A. Anti-Mullerian hormone: correlation of early follicular, ovulatory and midluteal levels with ovarian response and cycle outcome in intracytoplasmic sperm injection patients. Fertil Steril. 2008 Jun;89(6):1670-6. doi: 10.1016/j.fertnstert.2007.05.040. Epub 2007 Jul 20.

  PMID: 17658520 BACKGROUND

• Honnma H, Baba T, Sasaki M, Hashiba Y, Oguri H, Fukunaga T, Endo T, Asada Y. Different ovarian response by age in an anti-Mullerian hormone-matched group undergoing in vitro fertilization. J Assist Reprod Genet. 2012 Feb;29(2):117-25. doi: 10.1007/s10815-011-9675-9. Epub 2011 Nov 16.

  PMID: 22086616 BACKGROUND

• La Marca A, Giulini S, Tirelli A, Bertucci E, Marsella T, Xella S, Volpe A. Anti-Mullerian hormone measurement on any day of the menstrual cycle strongly predicts ovarian response in assisted reproductive technology. Hum Reprod. 2007 Mar;22(3):766-71. doi: 10.1093/humrep/del421. Epub 2006 Oct 27.

  PMID: 17071823 BACKGROUND

• Muttukrishna S, McGarrigle H, Wakim R, Khadum I, Ranieri DM, Serhal P. Antral follicle count, anti-mullerian hormone and inhibin B: predictors of ovarian response in assisted reproductive technology? BJOG. 2005 Oct;112(10):1384-90. doi: 10.1111/j.1471-0528.2005.00670.x.

  PMID: 16167941 BACKGROUND

• Nardo LG, Gelbaya TA, Wilkinson H, Roberts SA, Yates A, Pemberton P, Laing I. Circulating basal anti-Mullerian hormone levels as predictor of ovarian response in women undergoing ovarian stimulation for in vitro fertilization. Fertil Steril. 2009 Nov;92(5):1586-93. doi: 10.1016/j.fertnstert.2008.08.127. Epub 2008 Oct 18.

  PMID: 18930213 BACKGROUND

• Singh N, Malik E, Banerjee A, Chosdol K, Sreenivas V, Mittal S. "Anti-Mullerian Hormone: Marker for Ovarian Response in Controlled Ovarian Stimulation for IVF Patients": A First Pilot Study in the Indian Population. J Obstet Gynaecol India. 2013 Aug;63(4):268-72. doi: 10.1007/s13224-012-0318-6. Epub 2013 Feb 22.

  PMID: 24431654 BACKGROUND

• Wu CH, Chen YC, Wu HH, Yang JG, Chang YJ, Tsai HD. Serum anti-Mullerian hormone predicts ovarian response and cycle outcome in IVF patients. J Assist Reprod Genet. 2009 Jul;26(7):383-9. doi: 10.1007/s10815-009-9332-8.

  PMID: 19768530 BACKGROUND

• Alviggi C, Humaidan P, Ezcurra D. Hormonal, functional and genetic biomarkers in controlled ovarian stimulation: tools for matching patients and protocols. Reprod Biol Endocrinol. 2012 Feb 6;10:9. doi: 10.1186/1477-7827-10-9.

  PMID: 22309877 BACKGROUND

• Bosch E, Ezcurra D. Individualised controlled ovarian stimulation (iCOS): maximising success rates for assisted reproductive technology patients. Reprod Biol Endocrinol. 2011 Jun 21;9:82. doi: 10.1186/1477-7827-9-82.

  PMID: 21693025 BACKGROUND

• Broer SL, Dolleman M, Opmeer BC, Fauser BC, Mol BW, Broekmans FJ. AMH and AFC as predictors of excessive response in controlled ovarian hyperstimulation: a meta-analysis. Hum Reprod Update. 2011 Jan-Feb;17(1):46-54. doi: 10.1093/humupd/dmq034. Epub 2010 Jul 28.

  PMID: 20667894 BACKGROUND

• Fleming R, Broekmans F, Calhaz-Jorge C, Dracea L, Alexander H, Nyboe Andersen A, Blockeel C, Jenkins J, Lunenfeld B, Platteau P, Smitz J, de Ziegler D. Can anti-Mullerian hormone concentrations be used to determine gonadotrophin dose and treatment protocol for ovarian stimulation? Reprod Biomed Online. 2013 May;26(5):431-9. doi: 10.1016/j.rbmo.2012.02.027. Epub 2013 Feb 4.

  PMID: 23507133 BACKGROUND

• La Marca A, Sunkara SK. Individualization of controlled ovarian stimulation in IVF using ovarian reserve markers: from theory to practice. Hum Reprod Update. 2014 Jan-Feb;20(1):124-40. doi: 10.1093/humupd/dmt037. Epub 2013 Sep 29.

  PMID: 24077980 BACKGROUND

• Martinez F, Clua E, Carreras O, Tur R, Rodriguez I, Barri PN. Is AMH useful to reduce low ovarian response to GnRH antagonist protocol in oocyte donors? Gynecol Endocrinol. 2013 Aug;29(8):754-7. doi: 10.3109/09513590.2013.801443. Epub 2013 Jun 12.

  PMID: 23758138 BACKGROUND

• Nakhuda GS, Douglas NC, Thornton MH, Guarnaccia MM, Lobo R, Sauer MV. Anti-Mullerian hormone testing is useful for individualization of stimulation protocols in oocyte donors. Reprod Biomed Online. 2010 Jan;20(1):42-7. doi: 10.1016/j.rbmo.2009.10.009. Epub 2009 Oct 30.

  PMID: 20158986 BACKGROUND

• Nelson SM, Yates RW, Fleming R. Serum anti-Mullerian hormone and FSH: prediction of live birth and extremes of response in stimulated cycles--implications for individualization of therapy. Hum Reprod. 2007 Sep;22(9):2414-21. doi: 10.1093/humrep/dem204. Epub 2007 Jul 18.

  PMID: 17636277 BACKGROUND

• Yates AP, Rustamov O, Roberts SA, Lim HY, Pemberton PW, Smith A, Nardo LG. Anti-Mullerian hormone-tailored stimulation protocols improve outcomes whilst reducing adverse effects and costs of IVF. Hum Reprod. 2011 Sep;26(9):2353-62. doi: 10.1093/humrep/der182. Epub 2011 Jun 13.

  PMID: 21672928 BACKGROUND

MeSH Terms

Conditions

Infertility

Interventions

follitropin alfa; Follicle Stimulating Hormone; Menotropins

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropins, Pituitary; Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Peptides; Amino Acids, Peptides, and Proteins; Biological Products; Complex Mixtures

Study Officials

• Linda Sung, MD

  Reproductive Specialists of New York

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2017
• First Posted: March 31, 2017
• Study Start: October 22, 2015
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: April 12, 2018

Record last verified: 2018-04