TRAP Study: Testosterone for Androgen Receptor Polymorphism
NCT ID: NCT06195163
Last Updated: 2025-05-09
Study Results
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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NOT_YET_RECRUITING
PHASE4
100 participants
INTERVENTIONAL
2025-09-30
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Study group
Daily 10 mg transdermal testosterone for 21 days prior to the start of ovarian stimulation.
Transdermal Gel in Sachet Dosage Form
Transdermal testosterone gel application prior to ovarian stimulation in the study group.
Control group
No pre-treatment prior to ovarian stimulation.
No pretreatment
No pretreatment prior to the ovarian stimulation in the control group.
Interventions
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Transdermal Gel in Sachet Dosage Form
Transdermal testosterone gel application prior to ovarian stimulation in the study group.
No pretreatment
No pretreatment prior to the ovarian stimulation in the control group.
Eligibility Criteria
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Inclusion Criteria
1. Age equal to or greater than 40 years.
2. Previous cycle with less than 4 oocytes retrieved.
3. Low ovarian reserve markers (antral follicle count \<5-7; AMH \<0.5-1.1 ng).
* Carriers of androgen receptor polymorphism: between 22 and 24 CAG repeats.
* Body Mass Index (BMI) less than 32.
* Indication for in vitro fertilization.
* Presence of both ovaries.
* Absence of ovarian cysts.
* Absence of endometriosis.
* Normal karyotype and fragile X study.
* Absence of severe male factor.
* Semen sample from ejaculate.
* Ability to comply with the study protocol.
* To have given written consent.
Exclusion Criteria
* Concurrent participation in another study.
18 Years
40 Years
FEMALE
Yes
Sponsors
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Instituto Bernabeu
OTHER
Responsible Party
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Andrea Bernabeu García
Principal Investigator
Locations
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Instituto Bernabeu
Alicante, Alicante, Spain
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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IBMR46
Identifier Type: -
Identifier Source: org_study_id
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