TRAP Study: Testosterone for Androgen Receptor Polymorphism
Launched by INSTITUTO BERNABEU · Dec 22, 2023
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
The TRAP Study is a research trial that aims to find out if using a skin patch with testosterone can help women with fertility issues, particularly those who have a low number of healthy eggs and a specific genetic variation associated with androgen receptors. The main goal is to see if this treatment can increase the number of egg cells (called cumulus-oocyte complexes) collected during a procedure known as intracytoplasmic sperm injection (ICSI). This study is currently not recruiting participants, but it will focus on women aged between 22 and 40 who have certain fertility challenges.
To participate, women must meet specific criteria, such as having a low ovarian reserve (which means having fewer eggs than normal), being carriers of a certain genetic marker, and having a body mass index (BMI) under 32. Additionally, they should be planning to undergo in vitro fertilization and must have both ovaries. Participants will need to provide consent and follow the study guidelines. If you meet these requirements and are interested, this trial could provide valuable insights into improving fertility treatment options for women facing similar challenges.
Gender
FEMALE
Eligibility 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.
About Instituto Bernabeu
Instituto Bernabeu is a leading reproductive health and fertility clinic dedicated to providing advanced medical care and innovative treatments for individuals and couples seeking to conceive. With a focus on evidence-based practices and cutting-edge technologies, the institute specializes in assisted reproductive techniques, including in vitro fertilization (IVF), gamete donation, and fertility preservation. Renowned for its commitment to patient-centered care, Instituto Bernabeu combines clinical excellence with a compassionate approach, ensuring that each patient's unique needs are met throughout their fertility journey. As a sponsor of clinical trials, the institute actively contributes to the advancement of reproductive medicine and the development of new therapeutic options.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Alicante, , Spain
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported