TESTOSTERONE for Low ovarian reserve (according to Bologna criteria) | Androgen receptor polymorphism

Inclusion criteria

• {"criterion_text":"- 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).\n- 10.\tMuestra seminal procedente de eyaculado.\n- 11.\tAbility to comply with the study protocol.\n- 12.\tTo have given their written consent.\n- 2.\tCarriers of the androgen receptor polymorphism: between 22 and 24 CAG repeats.\n- 3. Body Mass Index (BMI) less than 32.\n- 4.\tIndication for in vitro fertilization.\n- 5.\tPresence of both ovaries.\n- 6.\tAbsence of ovarian cysts.\n- 7.\tAbsence of endometriosis.\n- 8.\tKaryotype and normal fragile X study.\n- 9.\tAbsence of severe male factor."}

Exclusion criteria

• {"criterion_text":"- 1. Non-compliance with instructions or non-formalization of informed consent.\n- 2.\tConcurrent participation in another study."}

Primary endpoints

• {"endpoint_text":"- number of oocyte cumulus complexes obtained","definition_or_measurement_approach":"Count of cumulus-oocyte complexes (COCs) obtained after ovarian stimulation."}

Secondary endpoints

• {"endpoint_text":"- Number of metaphase II stage oocytes obtained.","definition_or_measurement_approach":"Count of oocytes in metaphase II (MII) obtained."}
• {"endpoint_text":"- Duration of stimulation (days)","definition_or_measurement_approach":"Number of days of ovarian stimulation (measured in days)."}
• {"endpoint_text":"- Dose of medication used","definition_or_measurement_approach":"Total dose of stimulation medication used (measured in medication-specific units)."}
• {"endpoint_text":"- Fertilization rate","definition_or_measurement_approach":"Proportion/percentage of oocytes that fertilize (fertilized oocytes/inseminated or injected oocytes)."}
• {"endpoint_text":"- Blastocyst formation rate","definition_or_measurement_approach":"Proportion/percentage of embryos reaching blastocyst stage (blastocysts/MII or per fertilized oocyte as specified)."}
• {"endpoint_text":"- Cancellation rate","definition_or_measurement_approach":"Proportion/percentage of cycles cancelled prior to oocyte retrieval."}
• {"endpoint_text":"- Viable intrauterine gestation (confirmed by ultrasound)","definition_or_measurement_approach":"Presence of viable intrauterine pregnancy confirmed by ultrasound."}

Spain

Earliest CTIS Part Ii Submission Date

01-02-2024

Latest Decision Or Authorization Date

29-04-2024

Processing Time Days

88

Number Of Sites

4

Number Of Participants

100

Primary sponsor

Full Name

Instituto Bernabeu S.L.

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Spain