Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
110
Countries
1
Sites
1
Infertility
To compare the two stimulation groups of 15 vs 20 mcg of follitropin-delta (equivalent to 225IU vs 300IU of rFSH) regarding the number of euploid embryos in advanced age women undergoing PGT-A with a PPOS protocol.
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 → ongoing
- Decision date (initial)
- 2023-11-14
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- FUNDACION SANTIAGO DEXEUS FONT
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
To compare the two stimulation groups of 15 vs 20 mcg of follitropin-delta (equivalent to 225IU vs 300IU of rFSH) regarding the number of euploid embryos in advanced age women undergoing PGT-A with a PPOS protocol.
Secondary objectives 25
- Total gonadotropin dose and length of stimulation
- Number of oocytes and mature oocytes (MIIs) retrieved
- Endocrine profile at specific intervals (estradiol, progesterone, FSH and LH)
- Follicle to Oocyte Index (FOI) (ratio between the total number of oocytes collected at the end of ovarian stimulation and the number of antral follicles available at the start of stimulation).
- Follicular Output RaTe (FORT) (ratio of the number of preovulatory follicles and the number of antral follicles available at the start of stimulation).
- Cycle cancelation rate
- Reason for cycle cancelation
- Fertilization rate
- Time of appearance of the 2nd polar body (tPB2)
- Time of pronuclei appearance (tPNa)
- Evaluation of both pronuclei (PN)
- Time of pronuclei disappearance (tPNf)
- Time of division from 2 to 8 cells (t2, t3, t4, t5, t6, t7, t8)
- Time of compactation (tSC)
- Time of morula (tM)
- Time of cavitation (tSB)
- Time of full blastulation (tB)
- Total number of day 5 blastocysts
- Total number of good quality blastocysts
- Total number of embryos
- Blastocyst formation rate, defined as the proportion of 2PN zygotes that reach the blastocyst stage
- Number of embryos cryopreserved
- Embryo stage (D5, D6, D7)
- Clinical pregnancy rate, defined as the visualization of one or more gestational sacs
- Ongoing pregnancy rate, defined as a viable intrauterine pregnancy of at least 8-10 weeks duration confirmed on an ultrasound scan
Conditions and MedDRA coding
Infertility
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | LLT | 10016398 | Female infertility | 10038604 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Infertile patients with indication for IVF
- Undergoing preimplantation genetic screening cycles
- Age >= 38 and < 42 years old
- AMH > 1.5 ng/ml and < 3.5 ng/ml (AMH result of up to one year will be valid)
- BMI 18.5 – 30 Kg/m2
Exclusion criteria 5
- Severe male factor requiring TESE (testicular sperm extraction)
- Administration of any other drug potentially interfering with the treatment
- 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).
- Monogenic disease to be detected with PGT-M
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- To compare the two stimulation groups of 15 vs 20 mcg of follitropin-delta (equivalent to 225IU vs 300IU of rFSH) regarding the number of euploid embryos in advanced age women undergoing PGT-A with a PPOS protocol
Secondary endpoints 25
- Total gonadotropin dose and length of stimulation
- Number of oocytes and mature oocytes (MIIs) retrieved
- Endocrine profile at specific intervals (estradiol, progesterone, FSH and LH)
- Follicle to Oocyte Index (FOI) (ratio between the total number of oocytes collected at the end of ovarian stimulation and the number of antral follicles available at the start of stimulation).
- Follicular Output RaTe (FORT) (ratio of the number of preovulatory follicles and the number of antral follicles available at the start of stimulation).
- Cycle cancelation rate
- Reason for cycle cancelation
- Fertilization rate
- Time of appearance of the 2nd polar body (tPB2)
- Time of pronuclei appearance (tPNa)
- Evaluation of both pronuclei (PN)
- Time of pronuclei disappearance (tPNf)
- Time of division from 2 to 8 cells (t2, t3, t4, t5, t6, t7, t8)
- Time of compactation (tSC)
- Time of morula (tM)
- Time of cavitation (tSB)
- Time of full blastulation (tB)
- Total number of day 5 blastocysts
- Total number of good quality blastocysts
- Total number of embryos
- Blastocyst formation rate, defined as the proportion of 2PN zygotes that reach the blastocyst stage
- Number of embryos cryopreserved
- Embryo stage (D5, D6, D7)
- Clinical pregnancy rate, defined as the visualization of one or more gestational sacs
- Ongoing pregnancy rate, defined as a viable intrauterine pregnancy of at least 8-10 weeks duration confirmed on an ultrasound scan
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
REKOVELLE 72 micrograms/2.16 mL solution for injection in a pre-filled pen
PRD6680136 · Product
- Active substance
- Follitropin Delta
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 20 µg microgram(s)
- Max total dose
- 300 µg microgram(s)
- Max treatment duration
- 15 Day(s)
- Authorisation status
- Authorised
- ATC code
- G03GA10 — -
- Marketing authorisation
- EU/1/16/1150/006
- MA holder
- FERRING PHARMACEUTICALS A/S
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 2
Seidigestan 200 mg cápsulas blandas
PRD308331 · Product
- Active substance
- Progesterone
- Pharmaceutical form
- CAPSULE, SOFT
- Route of administration
- ORAL
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 3000 mg milligram(s)
- Max treatment duration
- 15 Week(s)
- Authorisation status
- Authorised
- ATC code
- G03DA04 — PROGESTERONE
- Marketing authorisation
- 64.899
- MA holder
- SEID, S.A.
- MA country
- Spain
- 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
- 0.2 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
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 | Ongoing, recruiting | 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 | 2023-12-12 | 2023-12-14 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-07 | Spain | Acceptable 2023-11-03
|
2023-11-14 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-01 | Spain | Acceptable | 2024-03-19 |
| 3 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-05-23 | Spain | Acceptable 2024-07-04
|
2024-07-04 |