TRAP study: Testosterone for Androgen Receptor Polymorphism.

Phase 4

Withdrawn

Conditions: low ovarian reserve according to Bologna criteria and carriers of androgen receptor polymorphism

Registration Number: 2024-510596-37-00

Lead Sponsor: Instituto Bernabeu S.L.

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

Recruitment & Eligibility

Status: Not authorised

Sex: Female

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).

Muestra seminal procedente de eyaculado.
Ability to comply with the study protocol.
To have given their written consent.
Carriers of the 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.
Karyotype and normal fragile X study.
Absence of severe male factor.

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

Primary Outcome Measures

Name	Time	Method
number of oocyte cumulus complexes obtained		number of oocyte cumulus complexes obtained

Secondary Outcome Measures

Name	Time	Method
Number of metaphase II stage oocytes obtained.		Number of metaphase II stage oocytes obtained.
Duration of stimulation (days)		Duration of stimulation (days)
Dose of medication used		Dose of medication used
Fertilization rate		Fertilization rate
Blastocyst formation rate		Blastocyst formation rate
Cancellation rate		Cancellation rate
Viable intrauterine gestation (confirmed by ultrasound)		Viable intrauterine gestation (confirmed by ultrasound)

Trial Locations

Locations (4): Instituto Bernabeu Albacete S.L.
🇪🇸
Albacete, Spain
Instituto Bernabeu Palma De Mallorca S.L.
🇪🇸
Palma, Spain
Instituto Bernabeu Madrid S.L.
🇪🇸
Madrid, Spain
Instituto Bernabeu S.L.
🇪🇸
Alicante, Spain
Instituto Bernabeu Albacete S.L.
🇪🇸Albacete, Spain
Maria del Mar Perez Haro
Site contact
0034967100055
research@institutobernabeu.com