TRAP Study: Testosterone for Androgen Receptor Polymorphism

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).

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Key information

Conditions

Fertility Disorders

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Instituto Bernabeu

Alicante, 03016, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Age equal to or greater than 40 years.
Previous cycle with less than 4 oocytes retrieved.
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.

Treatment and study plan

Transdermal Gel in Sachet Dosage Form

Drug

Transdermal testosterone gel application prior to ovarian stimulation in the study group.

No pretreatment

Drug

No pretreatment prior to the ovarian stimulation in the control group.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Instituto Bernabeu

Other

Registry information

Official study title

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

Acronym: TRAP

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Jan 8, 2024
Registry last updated: May 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed