Status:
NOT_YET_RECRUITING
TRAP Study: Testosterone for Androgen Receptor Polymorphism
Lead Sponsor:
Instituto Bernabeu
Conditions:
Fertility Disorders
Eligibility:
FEMALE
18-40 years
Phase:
PHASE4
Brief 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...
Eligibility Criteria
Inclusion
- Patients with low ovarian reserve according to Bologna criteria: at least two of the following three:
- Age equal to or greater than 40 years.
- Previous cycle with less than 4 oocytes retrieved.
- 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
- Non-compliance with instructions or non-formalization of informed consent.
- Concurrent participation in another study.
Key Trial Info
Start Date :
September 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06195163
Start Date
September 30 2025
End Date
December 31 2026
Last Update
May 9 2025
Active Locations (1)
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1
Instituto Bernabeu
Alicante, Alicante, Spain, 03016