Overview
Sponsor-declared trial summary
Infertility
To compare the number of mature oocytes (MII) retrieved after 2-shot sequential administration of Corifollitropin alpha (CFA) and a unique administration of CFA followed by the administration of rFSH daily for ovarian stimulation (OS) in patients undergoing elective fertility preservation in a progestin-primed ovarian …
Key facts
- Sponsor
- Santiago Dexeus Font Fundacio Privada
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Trial duration
- 12 Dec 2023 → 9 Sep 2025
- Decision date (initial)
- 2023-10-26
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- ORGANON SPAIN
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To compare the number of mature oocytes (MII) retrieved after 2-shot sequential administration of Corifollitropin alpha (CFA) and a unique administration of CFA followed by the administration of rFSH daily for ovarian stimulation (OS) in patients undergoing elective fertility preservation in a progestin-primed ovarian stimulation (PPOS) protocol and GnRH-agonist (GnRH-a) triggering.
Secondary objectives 5
- Total number of oocytes retrieved
- Endocrine profile on the day of trigger (FSH, LH, Estradiol, progesterone)
- Incidence of OHSS
- Quality of life questionnaire “FertiQoL”
- Length of stimulation
Conditions and MedDRA coding
Infertility
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10021930 | Infertility NOS | 10038604 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- AFC ≤ 20
- Anti-Mullerian hormone (AMH) ≤ 3ng/ml (AMH result of up to one year will be valid)
- Between 18 and 40 years old
- BMI > 18 and < 30 kg/m2
- Able to come to the Center to comply with the procedures of the study: blood tests, appointments and drug dispensation
Exclusion criteria 7
- Medically indicated fertility preservation
- AFC > 20
- Polycystic ovarian syndrome (PCOS) according to the Rotterdam criteria
- FSH ≥ 20
- History of untreated autoimmune, endocrine, or metabolic disorders
- Contraindication for hormonal treatment
- Recent history of severe disease requiring regular treatment (clinically significant concurrent medical condition that could compromise subject safety or interfered with the trial assessment).
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- To compare the number of MII oocytes retrieved after final oocyte maturation with a 2-shot sequential administration of CFA or a unique administration of CFA followed by daily rFSH for controlled ovarian stimulation in patients undergoing elective fertility preservation.
Secondary endpoints 5
- Total number of oocytes retrieved
- Endocrine profile on the day of trigger (FSH, LH, estradiol, progesterone)
- Incidence of OHSS
- Quality of life questionnaire “FertiQoL”
- Length of stimulation
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Elonva 100 micrograms solution for injection
PRD9049682 · Product
- Active substance
- Corifollitropin Alfa
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 100 µg microgram(s)
- Max total dose
- 100 µg microgram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- G03GA09 — -
- Marketing authorisation
- EU/1/09/609/001
- MA holder
- N.V. ORGANON
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
Puregon 900 IU/1.08 ml solution for injection
PRD9022797 · Product
- Active substance
- Follitropin Beta
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 200 IU international unit(s)
- Max total dose
- 2000 IU international unit(s)
- Max treatment duration
- 10 Day(s)
- Authorisation status
- Authorised
- ATC code
- G03GA06 — FOLLITROPIN BETA
- Marketing authorisation
- EU/1/96/008/041
- MA holder
- N.V. ORGANON
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 3
Cerazet 75 microgramos comprimidos recubiertos con película
PRD8838400 · Product
- Active substance
- Desogestrel
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 75 µg microgram(s)
- Max total dose
- 750 µg microgram(s)
- Max treatment duration
- 10 Day(s)
- Authorisation status
- Authorised
- ATC code
- G03AC09 — DESOGESTREL
- Marketing authorisation
- 62285
- MA holder
- ORGANONSALUD, S.L.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Elonva 150 micrograms solution for injection
PRD9049686 · Product
- Active substance
- Corifollitropin Alfa
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS 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 — -
- Marketing authorisation
- EU/1/09/609/002
- MA holder
- N.V. ORGANON
- MA country
- Norway
- 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 INJECTION
- Max daily dose
- 0.1 mg milligram(s)
- Max total dose
- 0.1 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
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Santiago Dexeus Font Fundacio Privada
- Sponsor organisation
- Santiago Dexeus Font Fundacio Privada
- Address
- Gran Via De Carles III 71-75
- City
- Barcelona
- Postcode
- 08028
- Country
- Spain
Scientific contact point
- Organisation
- Santiago Dexeus Font Fundacio Privada
- Contact name
- Unidad Soporte Investigación
Public contact point
- Organisation
- Santiago Dexeus Font Fundacio Privada
- Contact name
- Unidad Soporte Investigación
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 194 | 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 | 2023-12-12 | 2025-09-09 | 2023-12-19 | 2025-08-28 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-30 | Spain | Acceptable 2023-10-20
|
2023-10-26 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-04-04 | Spain | Acceptable | 2024-04-17 |