TRAP Study: Testosterone for Androgen Receptor Polymorphism

Instituto Bernabeu

Status and phase: Not yet enrolling; Phase 4

Conditions: Fertility Disorders

Treatments: Drug: Transdermal Gel in Sachet Dosage Form; Drug: No pretreatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06195163

IBMR46

Details and patient eligibility

About

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).

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Study group

Experimental group

Description:

Daily 10 mg transdermal testosterone for 21 days prior to the start of ovarian stimulation.

Treatment:

Drug: Transdermal Gel in Sachet Dosage Form

Control group

Active Comparator group

Description:

No pre-treatment prior to ovarian stimulation.

Treatment:

Drug: No pretreatment