Overview
Sponsor-declared trial summary
low ovarian reserve according to Bologna criteria and carriers of androgen receptor polymorphism
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).
Key facts
- Sponsor
- Instituto Bernabeu S.L.
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Decision date (initial)
- 2025-10-06
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- BESINS HEALTHCARE
External identifiers
- EU CT number
- 2024-510596-37-01
- ClinicalTrials.gov
- NCT06195163
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Efficacy
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).
Secondary objectives 1
- To assess whether there are differences between the two groups in terms of: number of mature (MII) oocytes, fertilization rate, blastocyst formation rate (blastocysts/MII), number of follicles >14 mm on the day of GnRH agonist administration to trigger final oocyte maturation, duration of stimulation, gonadotropin consumption, cycle cancellation rate, free androgen index value and gestation rate.
Conditions and MedDRA coding
low ovarian reserve according to Bologna criteria and carriers of androgen receptor polymorphism
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-510596-37-00 | Transdermal testosterone pretreatment in poor responders with androgen receptor polymorphism undergoing ICSI: A Randomized Clinical Investigation. | Instituto Bernabeu S.L. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 12
- 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).
- 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.
- 10. Muestra seminal procedente de eyaculado.
- 11. Ability to comply with the study protocol.
- 12. To have given their written consent.
Exclusion criteria 2
- 1. Non-compliance with instructions or non-formalization of informed consent.
- 2. Concurrent participation in another study.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- number of oocyte cumulus complexes obtained
Secondary endpoints 7
- Number of metaphase II stage oocytes obtained.
- Duration of stimulation (days)
- Dose of medication used
- Fertilization rate
- Blastocyst formation rate
- Cancellation rate
- Viable intrauterine gestation (confirmed by ultrasound)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD12749027 · Product
- Active substance
- Testosterone
- Pharmaceutical form
- GEL
- Route of administration
- TRANSDERMAL USE
- Max daily dose
- 11 mg milligram(s)
- Max total dose
- 231 mg milligram(s)
- Max treatment duration
- 21 Day(s)
- Authorisation status
- Not Authorised
- ATC code
- G03BA03 — TESTOSTERONE
- MA holder
- BESINS HEALTHCARE IRELAND LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Auxiliary 3
Bemfola 300 IU/0.50 mL solution for injection in pre-filled pen
PRD4656304 · Product
- Active substance
- Follitropin Alfa
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0.25 mg milligram(s)
- Max total dose
- 2.5 mg milligram(s)
- Max treatment duration
- 10 Day(s)
- Authorisation status
- Authorised
- ATC code
- G03GA05 — FOLLITROPIN ALFA
- Marketing authorisation
- EU/1/13/909/013
- MA holder
- GEDEON RICHTER PLC.
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Decapeptyl diario 0,1 mg polvo y disolvente para solución inyectable
PRD390680 · Product
- Active substance
- Triptorelin
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0.2 mg milligram(s)
- Max total dose
- 0.2 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L02AE04 — TRIPTORELIN
- Marketing authorisation
- 62.431
- MA holder
- IPSEN PHARMA SA
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Astarté 0,25 mg/0,5 ml solución inyectable en jeringa precargada EFG
PRD9301930 · Product
- Active substance
- Ganirelix
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0.25 mg milligram(s)
- Max total dose
- 2.5 mg milligram(s)
- Max treatment duration
- 10 Day(s)
- Authorisation status
- Authorised
- ATC code
- H01CC01 — GANIRELIX
- Marketing authorisation
- 86368
- MA holder
- GP-PHARM S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Instituto Bernabeu S.L.
- Sponsor organisation
- Instituto Bernabeu S.L.
- Address
- Avinguda Albufereta 31
- City
- Alicante
- Postcode
- 03016
- Country
- Spain
Scientific contact point
- Organisation
- Instituto Bernabeu S.L.
- Contact name
- Ana Fuentes Rozalen
Public contact point
- Organisation
- Instituto Bernabeu S.L.
- Contact name
- Ana Fuentes Rozalen
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 100 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 18 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protocolo v5 comparado con la version anterior | 5 |
| Protocol (for publication) | Protocolo_MR46_v2_25jan2024 | 2 |
| Protocol (for publication) | Protocolo_MR46_v3_13mar024 | 3 |
| Protocol (for publication) | Protocolo_MR46_v4_30mar2024 | 4 |
| Protocol (for publication) | Protocolo_MR46_v5_12may2025 | 5 |
| Protocol (for publication) | Protocolo_MR46_v6_03sept2025_def_signed | 6 |
| Protocol (for publication) | Protocolo_MR46_v6_03sept2025_signed | 6 |
| Protocol (for publication) | ProtocoloMR46_v1_22sep2023 | 1 |
| Recruitment arrangements (for publication) | Bernabeu Estudio TRAP Criterios reclutamiento | 1 |
| Recruitment arrangements (for publication) | Bernabeu Estudio TRAP_Criterios reclutamiento | 1 |
| Subject information and informed consent form (for publication) | CI_TRAP_v3_RFI_11ago2025 | 3 |
| Subject information and informed consent form (for publication) | HIP CI_estudio TRAP | 1 |
| Subject information and informed consent form (for publication) | HIP_CI_estudio TRAP_v2 | 2 |
| Subject information and informed consent form (for publication) | HIP_CI_estudio TRAP_v2_fecha y version | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | IMPD ANDROGEL 1pc GEL IN PUMP BHIIR2024011 | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES_v1_22sep2023 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES_v2_25ene2024 | 1 |
| Synopsis of the protocol (for publication) | Protocolo_resumen__MR46_v5_12may2025 | 5 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-06-19 | Spain | Acceptable with conditions 2025-10-06
|
2025-10-06 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-11-17 | Spain | Acceptable 2026-02-17
|
2026-02-18 |