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)
- 2024-04-29
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-510596-37-00
- 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
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
TESTOGEL 50 mg gel transdérmico en sobres
PRD548745 · Product
- Active substance
- Testosterone
- Pharmaceutical form
- TRANSDERMAL GEL IN SACHET
- Route of administration
- TRANSDERMAL USE
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 210 mg milligram(s)
- Max treatment duration
- 21 Day(s)
- Authorisation status
- Authorised
- ATC code
- G03BA03 — TESTOSTERONE
- Marketing authorisation
- 65016
- MA holder
- LABORATOIRES BESINS INTERNATIONAL
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 3
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
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
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 | Not authorised | 100 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-17 | Spain | Not acceptable 2024-04-29
|
2024-04-29 |