TRAP Study: Testosterone for Androgen Receptor Polymorphism
ConditionFertility Disorders
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorInstituto Bernabeu
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Non-compliance with instructions or non-formalization of informed consent.
Concurrent participation in another study.
Trial design
Design model
Parallel
Treatments tested in this trial
Transdermal Gel in Sachet Dosage Form
DrugTransdermal testosterone gel application prior to ovarian stimulation in the study group.
No pretreatment
DrugNo pretreatment prior to the ovarian stimulation in the control group.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Study groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of COC (cumulus-oocyte complexes)
If number of COC is higher at least by 1.5 in the experimental group.
Time frame
Egg collection day (between 8 and 14 days after starting of ovarian stimulation)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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