Overview
Sponsor-declared trial summary
Female infertility
To compare the number of total oocytes and metaphase II (MII) oocytes obtained after controlled ovarian stimulation with α-Corifolitropin vs. β-Folitropin in donors in whom medroxyprogesterone acetate (MPA) has been used to prevent early luteinisation.
Key facts
- Sponsor
- Ivi Valencia S.L., Ivi Valencia S.L.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Trial duration
- 17 Jun 2025 → ongoing
- Decision date (initial)
- 2023-12-13
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To compare the number of total oocytes and metaphase II (MII) oocytes obtained after controlled ovarian stimulation with α-Corifolitropin vs. β-Folitropin in donors in whom medroxyprogesterone acetate (MPA) has been used to prevent early luteinisation.
Conditions and MedDRA coding
Female infertility
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- - Signature of subject's informed consent prior to any trial-related activity. - Age between 18 and 35 years (inclusive). - Regular menstrual cycle, 25 to 35 days (both inclusive). - Absence of physical and mental illness at the time of donation at the discretion of the investigator. - BMI 18-28 kg/m2 (both inclusive) at the time of donation. - No personal or family history of interest at the discretion of the investigator. - Normal uterus and ovaries, without organic pathology. - No polycystic ovaries. - Antral follicle count greater than 12 in the sum of the two ovaries at the time of the selection visit. - Normal karyotype. - Negative screening for infectious diseases (Hepatitis B Virus, Hepatitis C Virus, Human Immunodeficiency Virus and Syphilis). - General analysis with haemogram, haemostasis and biochemistry with parameters within normality.
Exclusion criteria 1
- - Concurrent participation in another clinical trial. - Previous participation in this clinical trial. - Any systemic or metabolic disorder (i.e.: diabetes...) that contraindicates the use of gonadotrophins. - Personal history of thrombophlebitis and thromboembolic phenomena and AHT. - Severe hepatic insufficiency, cardiovascular disease. - Suspicion or evidence of breast or hormone-dependent genital organ malignancy - known hypersensitivity to MPA or its excipients - Use of long-term hormonal contraception (hormonal IUDs or subcutaneous implants) at least 1 month prior to inclusion - Any reason for exclusion from the oocyte donation programme
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Number of MII oocytes and mature oocyte rate
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
—
SCP180072 · ATC
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 150 µg microgram(s)
- Max total dose
- 150 µg microgram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- G03GA09 — CORIFOLLITROPIN ALFA
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
—
SCP727159 · ATC
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 225 IU international unit(s)
- Max total dose
- 4500 IU international unit(s)
- Max treatment duration
- 20 Day(s)
- Authorisation status
- Authorised
- ATC code
- G03GA06 — FOLLITROPIN BETA
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Ivi Valencia S.L.
- Sponsor organisation
- Ivi Valencia S.L.
- Address
- Placa Policia Local 3
- City
- Valencia
- Postcode
- 46015
- Country
- Spain
Scientific contact point
- Organisation
- Ivi Valencia S.L.
- Contact name
- Juan Giles Jumenez
Public contact point
- Organisation
- Ivi Valencia S.L.
- Contact name
- Juan Giles Jumenez
Ivi Valencia S.L.
- Sponsor organisation
- Ivi Valencia S.L.
- Address
- Placa Policia Local 3
- City
- Valencia
- Postcode
- 46015
- Country
- Spain
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 318 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Spain | 2025-06-17 | 2025-07-08 |
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) | 2304-VLC-051-JG_Protocolo v2 16102024_cc_redacted | 2 |
| Protocol (for publication) | Protocol 2023-506908-66-00_redacted | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_ELONVA | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_PUREGON | 1 |
| Synopsis of the protocol (for publication) | Protocol synopsis_ENG 2023-506908-66-00_redacted | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-18 | Spain | Acceptable 2023-12-13
|
2023-12-13 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-23 | Spain | Acceptable 2024-12-09
|
2024-12-09 |