Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruitment pending
Participants planned
160
Countries
1
Sites
3
Female Infertility
Quantify the mean difference in oocytes obtained with PRFG-Endoret® compared to placebo injection.
Key facts
- Sponsor
- Ivi Alicante S.L.
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Phenomena and Processes [G] - Reproductive and Urinary Physiological Phenomena [G08]
- Decision date (initial)
- 2025-07-30
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- BTI Biotechnology Institute
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
Quantify the mean difference in oocytes obtained with PRFG-Endoret® compared to placebo injection.
Conditions and MedDRA coding
Female Infertility
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- - Women with a diagnosis of low ovarian response according to POSEIDON III/IV criteria. - Age limited to between 18 and 42 years, inclusive - Regular cycles, on a monthly basis with an interval of 24 to 35 days. - Treatments limited to a single IVF/IVF PGT-A cycle, in which there will be no oocyte/embryo accumulation. - Normal karyotypes in both partners. - Complete preoperative blood work valid for 6 months according to standard clinical practice, with a minimum platelet count >160,000/mcL. - Negative serologies for HIV, HCV, HBV and RPR less than <3 months old. In case of not having a recent test, it will be performed at the in-study research centre at no cost to the patient. - Semen with a sperm count greater than 5 million motile sperm per ejaculate or sperm donation treatments. - Both ovaries accessible for vaginal puncture - BMI >18 kg/m2
Exclusion criteria 1
- - Diagnosis of ovarian failure or amenorrhoeic blips - Failure to meet POSEIDON III/IV criteria - Presence of autoimmune pathology, thrombophilias, use of anticoagulants or antiplatelet agents or history of cancer treatment (chemotherapy/radiotherapy) - Platelets with levels below 160xmcL, aplastic anaemia or thrombocytosis. - Presence of ovarian and/or tubal pathology; patients with a single ovary, previous ovarian surgery, hydrosalpinx, known ovarian endometrioma or dermoid cyst - BMI >35 kg/m2 - Male partner with less than 5 million total motile sperm per ejaculate and/or sample obtained by testicular biopsy. - Diagnosis of endometrial insufficiency, which is defined as endometrial thickness equal to or less than 6 mm in the previous cycle and/or presence of persistent endometrial fluid.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- number of oocytes retrieved after intraovarian administration of the study treatment, PRGF Endoret® vs. placebo
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB14918MIG · Substance
- Active substance
- Platelet Concentrate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 6 ml millilitre(s)
- Max total dose
- 6 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
Suero Fisiológico Braun 0,9% disolvente para uso parenteral Cloruro de sodio
PRD11896749 · Product
- Active substance
- Sodium Chloride
- Substance synonyms
- SODIUM CHLORID
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 6 ml millilitre(s)
- Max total dose
- 6 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V07AB — SOLVENTS AND DILUTING AGENTS, INCL. IRRIGATING SOLUTIONS
- Marketing authorisation
- 58449
- MA holder
- B.BRAUN MEDICAL, 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
Ivi Alicante S.L.
- Sponsor organisation
- Ivi Alicante S.L.
- Address
- Avinguda De Denia 111
- City
- Alicante
- Postcode
- 03015
- Country
- Spain
Scientific contact point
- Organisation
- Ivi Alicante S.L.
- Contact name
- Manuel Muñoz
Public contact point
- Organisation
- Ivi Alicante S.L.
- Contact name
- Manuel Muñoz
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 160 | 3 |
| 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 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | 2406-ALC-150-MM PROTOCOLO_DEF_redacted | 1 |
| Recruitment arrangements (for publication) | informedconsent_patientrecruitmentprocedure_RCT | 1 |
| Subject information and informed consent form (for publication) | 2406-ALC-150-MM CI_ f-241106_definitivo | 1 |
| Subject information and informed consent form (for publication) | 2406-ALC-150-MM HIP_ 28112024 definitivo | 1 |
| Synopsis of the protocol (for publication) | Resumen 2406-ALC-150-MM | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-04-15 | Spain | Acceptable with conditions 2025-07-28
|
2025-07-30 |