Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
60
Countries
1
Sites
1
Subfertility
To compare CFA / PPOS stimulation versus conventional rFSH / GnRH antagonist ovarian stimulation cycles with respect to mean treatment-related quality of life and patient satisfaction in both subjects undergoing elective fertility preservation and subjects undergoing PGT.
Key facts
- Sponsor
- Universitair Ziekenhuis Gent
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Phenomena and Processes [G] - Reproductive and Urinary Physiological Phenomena [G08]
- Trial duration
- 24 Jan 2025 → ongoing
- Decision date (initial)
- 2023-10-27
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Ghent University Hospital · Organon
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To compare CFA / PPOS stimulation versus conventional rFSH / GnRH antagonist ovarian
stimulation cycles with respect to mean treatment-related quality of life and patient satisfaction
in both subjects undergoing elective fertility preservation and subjects undergoing PGT.
Secondary objectives 1
- To evaluate if the effect of treatment regimen on mean treatment-related quality of life and patient satisfaction is different between subjects undergoing elective fertility preservation and subjects undergoing PGT treatment. Thus testing for effect modification of the treatment by indication for the treatment (preventive against therapeutic).
Conditions and MedDRA coding
Subfertility
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | PPOS and CFA for elective freeze-all ovarian stimulation cycles The aim of this study is to compare CFA/PPOS stimulation
(study arm 1) versus conventional rFSH/GnRH antagonist
ovarian stimulation (study arm 2)
|
Randomised Controlled | None | study arm 1: CFA/PPOS stimulation study arm 2: conventional rFSH/GnRH antagonist ovarian stimulation |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Group 1: indication for oocyte cryopreservation
- Group 2: indication for IVF/ICSI and PGT-A
- for both groups: First ovarian stimulation cycle
- for both groups: Aged ≥ 18 and < 41 years old at the time of first OPU
- for both groups: Body Mass Index (BMI) ≥ 18 kg/m² and < 32 kg/m²
Exclusion criteria 7
- Contra-indication for ovarian stimulation
- Expected poor ovarian response (Bologna Criteria)
- PCOS patients
- Refusal to fill out questionnaires before, during and after treatment
- Simultaneous participation in another clinical study
- Untreated and uncontrolled thyroid dysfunction
- Current use of oral contraceptives, anti-psychotics, anti-epileptics or chemotherapy
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Treatment-related quality of life and patient satisfaction retrieved from the second questionnaire (Q2), which is completed at the end of each stimulation cycle; after the agonist trigger and before the oocyte retrieval.
Secondary endpoints 1
- Patient feedback derived from the third questionnaire (Q3), which is completed within 3 weeks after completing the second stimulation cycle.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 10
Puregon 300 IU/0.36 mL solution for injection
PRD9022782 · Product
- Active substance
- Follitropin Beta
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 225 IU international unit(s)
- Max total dose
- 3150 IU international unit(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- G03GA06 — FOLLITROPIN BETA
- Marketing authorisation
- EU/1/96/008/038
- MA holder
- N.V. ORGANON
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Puregon 900 IU/1.08 mL solution for injection
PRD9022794 · Product
- Active substance
- Follitropin Beta
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 225 IU international unit(s)
- Max total dose
- 3150 IU international unit(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- G03GA06 — FOLLITROPIN BETA
- Marketing authorisation
- EU/1/96/008/041
- MA holder
- N.V. ORGANON
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Puregon 600 IU/0.72 mL solution for injection
PRD9022786 · Product
- Active substance
- Follitropin Beta
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 225 IU international unit(s)
- Max total dose
- 3150 IU international unit(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- G03GA06 — FOLLITROPIN BETA
- Marketing authorisation
- EU/1/96/008/039
- MA holder
- N.V. ORGANON
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Cerazette 75 microgram film-coated tablets
PRD9189910 · Product
- Active substance
- Desogestrel
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 75 µg microgram(s)
- Max total dose
- 1050 µg microgram(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- G03AC09 — DESOGESTREL
- Marketing authorisation
- PA23198/016/001
- MA holder
- ORGANON PHARMA (IRELAND) LIMITED
- MA country
- Ireland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Gonapeptyl Daily 0,1 mg/1 ml, oplossing voor injectie
PRD434759 · Product
- Active substance
- Triptorelin Acetate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 0.2 µg microgram(s)
- Max total dose
- 0.2 µg microgram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L02AE04 — TRIPTORELIN
- Marketing authorisation
- BE 339902
- MA holder
- FERRING N.V.
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Gonapeptyl Daily 0,1 mg/1 ml, solution injectable
PRD433987 · Product
- Active substance
- Triptorelin Acetate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 0.2 µg microgram(s)
- Max total dose
- 0.2 µg microgram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L02AE04 — TRIPTORELIN
- Marketing authorisation
- BE 339902
- MA holder
- FERRING N.V.
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Gonapeptyl Daily 0,1 mg/ml, Injektionslösung
PRD6816053 · Product
- Active substance
- Triptorelin Acetate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 0.2 µg microgram(s)
- Max total dose
- 0.2 µg microgram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L02AE04 — TRIPTORELIN
- Marketing authorisation
- BE 339902
- MA holder
- FERRING N.V.
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Elonva 150 micrograms solution for injection
PRD9049683 · 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
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Orgalutran 0.25 mg/0.5 mL solution for injection
PRD8889183 · Product
- Active substance
- Ganirelix
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 0.25 µg microgram(s)
- Max total dose
- 2.25 µg microgram(s)
- Max treatment duration
- 9 Day(s)
- Authorisation status
- Authorised
- ATC code
- H01CC01 — GANIRELIX
- Marketing authorisation
- EU/1/00/130/001
- MA holder
- N.V. ORGANON
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Orgalutran 0.25 mg/0.5 mL solution for injection
PRD8889187 · Product
- Active substance
- Ganirelix
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 0.25 µg microgram(s)
- Max total dose
- 2.25 µg microgram(s)
- Max treatment duration
- 9 Day(s)
- Authorisation status
- Authorised
- ATC code
- H01CC01 — GANIRELIX
- Marketing authorisation
- EU/1/00/130/002
- MA holder
- N.V. ORGANON
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitair Ziekenhuis Gent
- Sponsor organisation
- Universitair Ziekenhuis Gent
- Address
- Corneel Heymanslaan 10
- City
- Gent
- Postcode
- 9000
- Country
- Belgium
Scientific contact point
- Organisation
- Universitair Ziekenhuis Gent
- Contact name
- Sara Somers
Public contact point
- Organisation
- Universitair Ziekenhuis Gent
- Contact name
- Sara Somers
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 60 | 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 |
|---|---|---|---|---|---|
| Belgium | 2025-01-24 | 2025-01-27 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements public | 1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF adults public | 2.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF adults track changes | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF sponsor statement public | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF sponsor statement track changes | 2.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material study emergency card public | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-11 | Belgium | Acceptable 2023-10-27
|
2023-10-27 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-04-09 | Belgium | Acceptable 2023-10-27
|
2025-04-09 |