TRAP Study: Testosterone for Androgen Receptor Polymorphism

Summary

To determine whether pretreatment with transdermal testosterone increases the number of cumulus-oocyte complexes (COCs) obtained after ovarian stimulation by more than 1.5 in patients with low ovarian reserve and androgen receptor polymorphism undergoing intracytoplasmic sperm injection (ICSI).

Timeline

Start

2025-09-30

Primary completion

2026-09-30

Completion

2026-12-31

Publications

• Background Barbieri RL, Sluss PM, Powers RD, McShane PM, Vitonis A, Ginsburg E, Cramer DC. Association of body mass index, age, and cigarette smoking with serum testosterone levels in cycling women undergoing in vitro fertilization. Fertil Steril. 2005 Feb;83(2):302-8. doi: 10.1016/j.fertnstert.2004.07.956.
• Background Bosdou JK, Venetis CA, Dafopoulos K, Zepiridis L, Chatzimeletiou K, Anifandis G, Mitsoli A, Makedos A, Messinis IE, Tarlatzis BC, Kolibianakis EM. Transdermal testosterone pretreatment in poor responders undergoing ICSI: a randomized clinical trial. Hum Reprod. 2016 May;31(5):977-85. doi: 10.1093/humrep/dew028. Epub 2016 Mar 7.
• Background Bosdou JK, Venetis CA, Kolibianakis EM, Toulis KA, Goulis DG, Zepiridis L, Tarlatzis BC. The use of androgens or androgen-modulating agents in poor responders undergoing in vitro fertilization: a systematic review and meta-analysis. Hum Reprod Update. 2012 Mar-Apr;18(2):127-45. doi: 10.1093/humupd/dmr051. Epub 2012 Feb 3.
• Background Drakopoulos P, Bardhi E, Boudry L, Vaiarelli A, Makrigiannakis A, Esteves SC, Tournaye H, Blockeel C. Update on the management of poor ovarian response in IVF: the shift from Bologna criteria to the Poseidon concept. Ther Adv Reprod Health. 2020 Jul 31;14:2633494120941480. doi: 10.1177/2633494120941480. eCollection 2020 Jan-Dec.
• Background Duffy JMN, Bhattacharya S, Bhattacharya S, Bofill M, Collura B, Curtis C, Evers JLH, Giudice LC, Farquharson RG, Franik S, Hickey M, Hull ML, Jordan V, Khalaf Y, Legro RS, Lensen S, Mavrelos D, Mol BW, Niederberger C, Ng EHY, Puscasiu L, Repping S, Sarris I, Showell M, Strandell A, Vail A, van Wely M, Vercoe M, Vuong NL, Wang AY, Wang R, Wilkinson J, Youssef MA, Farquhar CM; Core Outcome Measure for Infertility Trials (COMMIT) initiative. Standardizing definitions and reporting guidelines for the infertility core outcome set: an international consensus development study. Fertil Steril. 2021 Jan;115(1):201-212. doi: 10.1016/j.fertnstert.2020.11.013. Epub 2020 Nov 30.
• 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.
• Background Laisk T, Haller-Kikkatalo K, Laanpere M, Jakovlev U, Peters M, Karro H, Salumets A. Androgen receptor epigenetic variations influence early follicular phase gonadotropin levels. Acta Obstet Gynecol Scand. 2010 Dec;89(12):1557-63. doi: 10.3109/00016349.2010.526182. Epub 2010 Nov 5.
• Background Lledo B, Llacer J, Ortiz JA, Martinez B, Morales R, Bernabeu R. A pharmacogenetic approach to improve low ovarian response: The role of CAG repeats length in the androgen receptor gene. Eur J Obstet Gynecol Reprod Biol. 2018 Aug;227:41-45. doi: 10.1016/j.ejogrb.2018.06.001. Epub 2018 Jun 4.
• Background Lledo B, Llacer J, Turienzo A, Ortiz JA, Guerrero J, Morales R, Ten J, Bernabeu R. Androgen receptor CAG repeat length is associated with ovarian reserve but not with ovarian response. Reprod Biomed Online. 2014 Oct;29(4):509-15. doi: 10.1016/j.rbmo.2014.06.012. Epub 2014 Jul 9.
• Background Lledo B, Ortiz JA, Llacer J, Bernabeu R. Pharmacogenetics of ovarian response. Pharmacogenomics. 2014 Apr;15(6):885-93. doi: 10.2217/pgs.14.49.
• Background Subira J, Algaba A, Vazquez S, Taroncher Dasi R, Molla Robles G, Monzo Fabuel S, Baydal V, Ruiz Herreros A, Garcia Camunas N, Rubio Rubio JM. Testosterone does not improve ovarian response in Bologna poor responders: a randomized controlled trial (TESTOPRIM). Reprod Biomed Online. 2021 Sep;43(3):466-474. doi: 10.1016/j.rbmo.2021.05.021. Epub 2021 May 30.
• Background Sunkara SK, Rittenberg V, Raine-Fenning N, Bhattacharya S, Zamora J, Coomarasamy A. Association between the number of eggs and live birth in IVF treatment: an analysis of 400 135 treatment cycles. Hum Reprod. 2011 Jul;26(7):1768-74. doi: 10.1093/humrep/der106. Epub 2011 May 10.
• Background Vendola KA, Zhou J, Adesanya OO, Weil SJ, Bondy CA. Androgens stimulate early stages of follicular growth in the primate ovary. J Clin Invest. 1998 Jun 15;101(12):2622-9. doi: 10.1172/JCI2081.

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