TRAP Study: Testosterone for Androgen Receptor Polymorphism

• Status: Not yet recruiting
• Trial end date: 2025-03-31
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Instituto Bernabeu

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.