Clinical trial NCT06195163: TRAP Study: Testosterone for Androgen Receptor Polymorphism
Official title: Transdermal Testosterone Pretreatment in Poor Responders With Androgen Receptor Polymorphism Undergoing ICSI: A Randomized Clinical Investigation.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Fertility Disorders
Keywords: ovarian stimulation; testosterone
Lead sponsor: Instituto Bernabeu
Sponsor class: OTHER
First posted: 2024-01-08
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 reserve and androgen receptor polymorphism undergoing intracytoplasmic sperm injection (ICSI).


Eligibility criteria: Inclusion Criteria:

* Patients with low ovarian reserve according to Bologna criteria: at least two of the following three:

  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:

* Non-compliance with instructions or non-formalization of informed consent.
* Concurrent participation in another study.

Primary outcomes:
measure: Number of COC (cumulus-oocyte complexes)
timeFrame: Egg collection day (between 8 and 14 days after starting of ovarian stimulation)
Secondary outcomes:
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: Instituto Bernabeu
Study officials:
References:
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