Fertility Disorders
Conditions
Keywords
ovarian stimulation; testosterone
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).
Interventions
DRUGTransdermal Gel in Sachet Dosage Form
Transdermal testosterone gel application prior to ovarian stimulation in the study group.
DRUGNo pretreatment
No pretreatment prior to the ovarian stimulation in the control group.
Sponsors
Instituto Bernabeu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of COC (cumulus-oocyte complexes) | 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. |
Countries
Spain
Outcome results
None listed