Overview
Sponsor-declared trial summary
Prevention of female infertility.
The aim of the current randomized controlled trial is to compare the efficacy of Random Start Ovarian Stimulation to conventional early follicular phase stimulation in Elective Oocyte Cryopreservation cycles.
Key facts
- Sponsor
- UZ Brussel
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Phenomena and Processes [G] - Reproductive and Urinary Physiological Phenomena [G08]
- Trial duration
- 19 Feb 2025 → ongoing
- Decision date (initial)
- 2024-10-10
- 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, Therapy
The aim of the current randomized controlled trial is to compare the efficacy of Random Start Ovarian Stimulation to conventional early follicular phase stimulation in Elective Oocyte Cryopreservation cycles.
Conditions and MedDRA coding
Prevention of female infertility.
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Age from ≥ 25 to ≤ 39 years
- Body mass Index (BMI) ≥18 to < 30 kg/m2
- Signed informed consent
- Regular menstrual cycle length i.e. 24-35 days
- Patients who are not taking hormonal contraception or who stopped hormonal contraception at least 2 months ago
- Normally accessible ovaries/ ovary
Exclusion criteria 5
- Patients currently taking hormonal contraception (including intrauterine devices)
- Contraindications to the use of gonadotropins
- Endometriosis grade 3-4
- Patients with Anti-müllerian hormone (AMH) <0.5 ng/mL (Revelli et al., JARG 2016) or AMH >3.2 ng/mL (Roche Diagnostics PCOM)
- Any untreated endocrine abnormality
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Total number of mature cryopreserved oocytes per ovarian stimulation (OS) cycle in elective oocyte cryopreservation.
Secondary endpoints 3
- The total number of oocytes retrieved
- Total consumption of gonadotropins (IU) used during Ovarian Stimulation
- Duration of Ovarian Stimulation, defined as the time from the first day of stimulation until the application of the trigger for the final oocyte maturation
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 5
Duphaston 10 mg filmomhulde tabletten
PRD11263823 · Product
- Active substance
- Dydrogesterone
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 30 mg milligram(s)
- Max total dose
- 630 mg milligram(s)
- Max treatment duration
- 21 Day(s)
- Authorisation status
- Authorised
- ATC code
- G03DB01 — DYDROGESTERONE
- Marketing authorisation
- BE071951
- MA holder
- THERAMEX IRELAND LIMITED
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Duphaston 10 mg comprimés pelliculés
PRD11263835 · Product
- Active substance
- Dydrogesterone
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 30 mg milligram(s)
- Max total dose
- 630 mg milligram(s)
- Max treatment duration
- 21 Day(s)
- Authorisation status
- Authorised
- ATC code
- G03DB01 — DYDROGESTERONE
- Marketing authorisation
- BE071951
- MA holder
- THERAMEX IRELAND LIMITED
- 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 mg/ml milligram(s)/millilitre
- Max total dose
- 0.2 mg/ml milligram(s)/millilitre
- 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
Bemfola 300 IU/0.50 mL solution for injection in pre-filled pen
PRD4656315 · Product
- Active substance
- Follitropin Alfa
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 300 IU international unit(s)
- Max total dose
- 6300 IU international unit(s)
- Max treatment duration
- 21 Day(s)
- Authorisation status
- Authorised
- ATC code
- G03GA05 — FOLLITROPIN ALFA
- Marketing authorisation
- EU/1/13/909/004
- MA holder
- GEDEON RICHTER PLC.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD11263821 · Product
- Active substance
- Dydrogesterone
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 30 mg milligram(s)
- Max total dose
- 630 mg milligram(s)
- Max treatment duration
- 21 Day(s)
- Authorisation status
- Authorised
- ATC code
- G03DB01 — DYDROGESTERONE
- Marketing authorisation
- BE071951
- MA holder
- THERAMEX IRELAND LIMITED
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
UZ Brussel
- Sponsor organisation
- UZ Brussel
- Address
- Laarbeeklaan 101
- City
- Jette
- Postcode
- 1090
- Country
- Belgium
Scientific contact point
- Organisation
- UZ Brussel
- Contact name
- Michel De Vos
Public contact point
- Organisation
- UZ Brussel
- Contact name
- Elsie Nulens
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 277 | 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 | 2025-02-19 | 2025-03-05 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 14 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-509919-89-00-redacted | 4 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF ENG-redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF FR-redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF NL-redacted | 4 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Bemfola FR | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Bemfola NL | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Duphaston FR | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Duphaston NL | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Gonapeptyl FR | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Gonapeptyl NL | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis DE 2023-509919-89-00_redacted | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis FR 2023-509919-89-00_redacted | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis NL 2023-509919-89-00_redacted | 2 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-30 | Belgium | Acceptable with conditions 2024-10-10
|
2024-10-10 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-19 | Belgium | Acceptable 2025-02-04
|
2025-02-05 |