TRAP Study: Testosterone for Androgen Receptor Polymorphism

Phase 4

Not yet recruiting

• Conditions: Fertility Disorders
• Interventions: Drug: Transdermal Gel in Sachet Dosage Form; Drug: No pretreatment

• Registration Number: NCT06195163
• Lead Sponsor: Instituto Bernabeu

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-22
• Study First Submitted QC: 2023-12-22
• Study First Posted: 2024-01-08
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-09
• Study Start: 2025-09-30
• Primary Completion: 2026-09-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group	Transdermal Gel in Sachet Dosage Form	Daily 10 mg transdermal testosterone for 21 days prior to the start of ovarian stimulation.
Control group	No pretreatment	No pre-treatment prior to ovarian stimulation.

Primary Outcome Measures

Name	Time	Method
Number of COC (cumulus-oocyte complexes)	Egg collection day (between 8 and 14 days after starting of ovarian stimulation)	If number of COC is higher at least by 1.5 in the experimental group.

Trial Locations

Locations (1)

Instituto Bernabeu; 🇪🇸 Alicante, Spain