TRAP study: Testosterone for Androgen Receptor Polymorphism.

Phase 1

• Conditions: low ovarian reserve according to Bologna criteria and carriers of androgen receptor polymorphism; Therapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]

• Registration Number: CTIS2024-510596-37-00
• Lead Sponsor: Instituto Bernabeu S.L.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-17
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 100

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)., 10.Muestra seminal procedente de eyaculado., 11.Ability to comply with the study protocol., 12.To have given their written consent., 2.Carriers of the androgen receptor polymorphism: between 22 and 24 CAG repeats., 3. Body Mass Index (BMI) less than 32., 4.Indication for in vitro fertilization., 5.Presence of both ovaries., 6.Absence of ovarian cysts., 7.Absence of endometriosis., 8.Karyotype and normal fragile X study., 9.Absence of severe male factor.

Exclusion Criteria

1. Non-compliance with instructions or non-formalization of informed consent., 2.Concurrent participation in another study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified