Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ended
Participants planned
110
Countries
1
Sites
1
infertility
To compare the two stimulation groups of CC plus rFSH 150IU vs. 300IU regarding the number of GQB according to the Istanbul Consensus criteria
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
- 9 Sep 2024 → 11 Mar 2026
- Decision date (initial)
- 2024-09-09
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-514322-23-00
- EudraCT number
- 2021-000941-42
- ClinicalTrials.gov
- NCT04983173
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To compare the two stimulation groups of CC plus rFSH 150IU vs. 300IU regarding the number of GQB according to the Istanbul Consensus criteria
Conditions and MedDRA coding
infertility
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | PT | 10021926 | Infertility | 100000004872 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- infertile patients undergoing ovarian stimulation for IVF
- AFC ≥ 5 and ≤ 10
- AMH ≤1.5 ng/ml (AMH result of up to one year will be valid)
- Age ≥ 35 years and ≤40 years
- BMI >18.5 and <25 kg/m2
- Willing to participate in the study
Exclusion criteria 6
- AFC >10
- History of untreated autoimmune, endocrine or metabolic disorders
- Contraindication for hormonal treatment
- Preimplantation genetic diagnosis
- Severe male factor (sperm concentration <5M/mL)
- Recent history of severe disease requiring regular treatment (clinically significant concurrent medical condition that could compromise subject safety or interfered with the trial assessment and patients with any contraindication of being pregnant).
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary efficacy endpoint is the number of good-quality blastocysts (GQB), according to the Istanbul Consensus Criteria. The primary efficacy endpoint is related to the primary trial objective.
Secondary endpoints 12
- Time of pronuclei appearance
- Time of pronuclei disappearance
- The total number of embryos
- Time of division from 2 to 8 cells
- Time of compactation
- Time of morula
- Time of cavitation
- Time of full blastulation
- Time of expanded blastocyst
- Time of hatched blastocyst
- Blastocyst formation rate
- Cycle cancelation rate
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
Ovaleap 900 IU/1.5 mL solution for injection
PRD6962945 · Product
- Active substance
- Follitropin Alfa (Genetical Recombination)
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 150 IU international unit(s)
- Max total dose
- 2250 IU international unit(s)
- Max treatment duration
- 15 Day(s)
- Authorisation status
- Authorised
- ATC code
- G03GA05 — FOLLITROPIN ALFA
- Marketing authorisation
- EU/1/13/871/003
- MA holder
- THERAMEX IRELAND LIMITED
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Ovaleap 450 IU/0.75 mL solution for injection
PRD6962944 · Product
- Active substance
- Follitropin Alfa (Genetical Recombination)
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 150 IU international unit(s)
- Max total dose
- 2250 IU international unit(s)
- Max treatment duration
- 15 Day(s)
- Authorisation status
- Authorised
- ATC code
- G03GA05 — FOLLITROPIN ALFA
- Marketing authorisation
- EU/1/13/871/002
- MA holder
- THERAMEX IRELAND LIMITED
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Ovaleap 300 IU/0.5 mL solution for injection
PRD6962943 · Product
- Active substance
- Follitropin Alfa (Genetical Recombination)
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 150 IU international unit(s)
- Max total dose
- 2250 IU international unit(s)
- Max treatment duration
- 15 Day(s)
- Authorisation status
- Authorised
- ATC code
- G03GA05 — FOLLITROPIN ALFA
- Marketing authorisation
- EU/1/13/871/001
- MA holder
- THERAMEX IRELAND LIMITED
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
PRD509571 · Product
- Active substance
- Clomifene Citrate
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 250 mg milligram(s)
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- G03GB02 — CLOMIFENE
- Marketing authorisation
- 43.880
- MA holder
- LABORATORIOS EFFIK S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 4
Orgalutran 0.25 mg/0.5 mL solution for injection
PRD8889190 · Product
- Active substance
- Ganirelix
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- 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
- EU/1/00/130/002
- MA holder
- N.V. ORGANON
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Ovitrelle 250 micrograms/0.5 mL solution for injection in pre-filled syringe
PRD3530802 · Product
- Active substance
- Choriogonadotropin Alfa
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 6500 IU international unit(s)
- Max total dose
- 6500 IU international unit(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- G03GA08 — CHORIOGONADOTROPIN ALFA
- Marketing authorisation
- EU/1/00/165/007
- MA holder
- MERCK EUROPE B.V.
- 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 USE
- 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
Utrogestan 200 mg cápsulas vaginales blandas
PRD10354307 · Product
- Active substance
- Progesterone, Micronised
- Pharmaceutical form
- VAGINAL CAPSULE, SOFT
- Route of administration
- VAGINAL USE
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 200 mg milligram(s)
- Max treatment duration
- 42 Day(s)
- Authorisation status
- Authorised
- ATC code
- G03DA04 — PROGESTERONE
- Marketing authorisation
- 88298
- MA holder
- BESINS HEALTHCARE IRELAND LIMITED
- 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
- Ignacio Rodriguez
Public contact point
- Organisation
- Santiago Dexeus Font Fundacio Privada
- Contact name
- Ignacio Rodriguez
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 110 | 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 | 2024-09-09 | 2026-03-11 | 2024-09-09 | 2025-12-16 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 9 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_PROTOCOLO INTENS-EQ_Trial_V2_02062021 | 1 |
| Recruitment arrangements (for publication) | K1_recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_HIPCI INTENS-EQ EN V2_02062021 | 1 |
| Subject information and informed consent form (for publication) | L1_HIPCI INTENS-EQ ESP V2_02062021 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_FT_OMIFIN | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ovaleap-epar-product-information_es | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ovaleap-epar-product-information_es | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ovaleap-epar-product-information_es | 1 |
| Synopsis of the protocol (for publication) | D1_RESUMEN INTENS-EQ V2 02062021 limpia | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-02 | Spain | Acceptable with conditions 2024-09-09
|
2024-09-09 |