TRAP Study: Testosterone for Androgen Receptor Polymorphism (TRAP)

May 6, 2025 updated by: Andrea Bernabeu García, Instituto Bernabeu

Transdermal Testosterone Pretreatment in Poor Responders With Androgen Receptor Polymorphism Undergoing ICSI: A Randomized Clinical Investigation.

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Alicante, Spain, 03016
        • Instituto Bernabeu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group
Daily 10 mg transdermal testosterone for 21 days prior to the start of ovarian stimulation.
Drug: Transdermal Gel in Sachet Dosage Form
Transdermal testosterone gel application prior to ovarian stimulation in the study group.
Active Comparator: Control group
No pre-treatment prior to ovarian stimulation.
Drug: No pretreatment
No pretreatment prior to the ovarian stimulation in the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of COC (cumulus-oocyte complexes)
Time Frame: 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.
Egg collection day (between 8 and 14 days after starting of ovarian stimulation)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Bernabeu

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 30, 2025

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

December 22, 2023

First Submitted That Met QC Criteria

December 22, 2023

First Posted (Actual)

January 8, 2024

Study Record Updates

Last Update Posted (Actual)

May 9, 2025

Last Update Submitted That Met QC Criteria

May 6, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IBMR46

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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