Clinical trial • Not applicable • Other
TESTOSTERONE for Low ovarian reserve | Androgen receptor polymorphism
Not applicable trial of TESTOSTERONE for Low ovarian reserve | Androgen receptor polymorphism.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Low ovarian reserve | Androgen receptor polymorphism
- Trial Stage
- Not applicable
- Drug Modality
- Small molecule|Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 19-06-2025
- First CTIS Authorization Date
- 06-10-2025
Trial design
Randomised, testosterone gel 1% (testosterone) — transdermal gel; max daily dose 11 mg; max treatment period 21 days; placebo: transparent gel pump where active substance (testosterone) is replaced by purified water. auxiliary medicines used in cycles include decapeptyl (triptorelin) subcutaneous 0.2 mg, astarté (ganirelix) 0.25 mg subcutaneous, and bemfola (follitropin alfa) injection (as per local regimen).-controlled Not applicable trial across 4 sites in Spain.
- Randomised
- Yes
- Comparator
- Testosterone Gel 1% (Testosterone) — transdermal gel; max daily dose 11 mg; max treatment period 21 days; Placebo: transparent gel pump where active substance (testosterone) is replaced by purified water. Auxiliary medicines used in cycles include Decapeptyl (triptorelin) subcutaneous 0.2 mg, Astarté (ganirelix) 0.25 mg subcutaneous, and Bemfola (follitropin alfa) injection (as per local regimen).
- Biomarker Stratified
- True, Androgen receptor CAG repeat length (22-24 CAG repeats)
- Target Sample Size
- 100
Eligibility
Recruits 100 No vulnerable population selected; adult female participants only. Written informed consent is required..
- Vulnerable Population
- No vulnerable population selected; adult female participants only. Written informed consent is required.
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)."}
- {"criterion_text":"- 10.\tMuestra seminal procedente de eyaculado."}
- {"criterion_text":"- 11.\tAbility to comply with the study protocol."}
- {"criterion_text":"- 12.\tTo have given their written consent."}
- {"criterion_text":"- 2.\tCarriers of the androgen receptor polymorphism: between 22 and 24 CAG repeats."}
- {"criterion_text":"- 3. Body Mass Index (BMI) less than 32."}
- {"criterion_text":"- 4.\tIndication for in vitro fertilization."}
- {"criterion_text":"- 5.\tPresence of both ovaries."}
- {"criterion_text":"- 6.\tAbsence of ovarian cysts."}
- {"criterion_text":"- 7.\tAbsence of endometriosis."}
- {"criterion_text":"- 8.\tKaryotype and normal fragile X study."}
- {"criterion_text":"- 9.\tAbsence of severe male factor."}
Exclusion criteria
- {"criterion_text":"- 1. Non-compliance with instructions or non-formalization of informed consent."}
- {"criterion_text":"- 2.\tConcurrent participation in another study."}
Endpoints
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 at metaphase II (MII) stage obtained."}
- {"endpoint_text":"- Duration of stimulation (days)","definition_or_measurement_approach":"Number of days of ovarian stimulation."}
- {"endpoint_text":"- Dose of medication used","definition_or_measurement_approach":"Total dose(s) of medication used during the stimulation cycle (as recorded in treatment records)."}
- {"endpoint_text":"- Fertilization rate","definition_or_measurement_approach":"Proportion of oocytes fertilized (fertilized oocytes / inseminated/injected oocytes)."}
- {"endpoint_text":"- Blastocyst formation rate","definition_or_measurement_approach":"Proportion of embryos reaching blastocyst stage (blastocysts / MII or fertilized oocytes as specified in protocol)."}
- {"endpoint_text":"- Cancellation rate","definition_or_measurement_approach":"Proportion of cycles cancelled prior to oocyte retrieval."}
- {"endpoint_text":"- Viable intrauterine gestation (confirmed by ultrasound)","definition_or_measurement_approach":"Presence of a viable intrauterine pregnancy confirmed by ultrasound."}
Recruitment
- Planned Sample Size
- 100
- Recruitment Window Months
- 15
- Consent Approach
- Written informed consent required from participants; subject information and informed consent form documents are listed in the trial documents. Participants are adult females and provide their own written consent. No assent process described.
Geography
- Total Number Of Sites
- 4
- Total Number Of Participants
- 100
Spain
- Earliest CTIS Part Ii Submission Date
- 11-08-2025
- Latest Decision Or Authorization Date
- 06-10-2025
- Processing Time Days
- 56
- Number Of Sites
- 4
- Number Of Participants
- 100
Sites
- Site Name
- Instituto Bernabeu Palma De Mallorca S.L.
- Department Name
- Reproductive Medicine Palma de Mallorca
- Contact Person Name
- Cecilia Quetglas
- Contact Person Email
- research@institutobernabeu.com
- Site Name
- Instituto Bernabeu Madrid S.L.
- Department Name
- Reproductive Medicine Madrid
- Contact Person Name
- Rosa Maria Daurelio
- Contact Person Email
- research@institutobernabeu.com
- Site Name
- Instituto Bernabeu S.L.
- Department Name
- Reproductive Medicine Alicante
- Contact Person Name
- Ana Fuentes
- Contact Person Email
- research@institutobernabeu.com
- Site Name
- Instituto Bernabeu Albacete S.L.
- Department Name
- Reproductive Medicine Albacete
- Contact Person Name
- Maria del Mar Perez Haro
- Contact Person Email
- research@institutobernabeu.com
Sponsor
Primary sponsor
- Full Name
- Instituto Bernabeu S.L.
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- Testosterone Gel 1%
- Active Substance
- TESTOSTERONE
- Modality
- Small molecule
- Routes Of Administration
- TRANSDERMAL USE
- Route
- Transdermal
- Authorisation Status
- prodAuthStatus 1
- Starting Dose
- 11 mg (max daily dose listed 11 mg)
- Frequency
- Daily (as transdermal application)
- Maximum Dose
- 11 mg daily (maxTotalAmount 231 mg over treatment period)
- Investigational Product Name
- Bomba de gel transparente, donde la sustancia activa (testosterona) fue sustituida por agua purificada.
- Modality
- Other
- Investigational Product Name
- Decapeptyl diario 0,1 mg polvo y disolvente para solución inyectable
- Active Substance
- TRIPTORELIN
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SUBCUTANEOUS
- Route
- Subcutaneous
- Authorisation Status
- prodAuthStatus 2
- Starting Dose
- 0.2 mg
- Frequency
- Single/as per protocol (maxDailyDoseAmount 0.2 mg)
- Maximum Dose
- 0.2 mg
- Investigational Product Name
- Astarté 0,25 mg/0,5 ml solución inyectable en jeringa precargada EFG
- Active Substance
- GANIRELIX
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SUBCUTANEOUS
- Route
- Subcutaneous
- Authorisation Status
- prodAuthStatus 2
- Starting Dose
- 0.25 mg
- Frequency
- Daily as per protocol (maxDailyDoseAmount 0.25 mg)
- Maximum Dose
- 0.25 mg daily; maxTotalDoseAmount 2.5 mg
- Investigational Product Name
- Bemfola 300 IU/0.50 mL solution for injection in pre-filled pen
- Active Substance
- FOLLITROPIN ALFA
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SUBCUTANEOUS
- Route
- Subcutaneous
- Authorisation Status
- prodAuthStatus 2
- Frequency
- As per stimulation regimen (product provided in pre-filled pen)
- Combination Treatment
- Yes
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