Overview
Sponsor-declared trial summary
Volutary women who wish to donate their oocytes
To evaluate the effect of FE 999049 on the number of cumulus-oocyte complexes (COCs) when a Primed Progestin Ovarian Stimulation (PPOS) protocol is associated to both conventional follicular phase stimulation and Luteal phase Ovarian Stimulation (LPOS) protocol in oocyte donors.
Key facts
- Sponsor
- Universitair Ziekenhuis Brussel
- Participant type
- Healthy volunteers, Patients
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Trial duration
- 2 Feb 2023 → ongoing
- Decision date (initial)
- 2024-07-31
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-513998-48-00
- EudraCT number
- 2022-003049-37
- ClinicalTrials.gov
- NCT05521828
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Efficacy
To evaluate the effect of FE 999049 on the number of cumulus-oocyte complexes (COCs) when a Primed Progestin Ovarian Stimulation (PPOS) protocol is associated to both conventional follicular phase stimulation and Luteal phase Ovarian Stimulation (LPOS) protocol in oocyte donors.
Secondary objectives 1
- To determine whether LPOS using PPOS protocol has comparable outcomes to conventional follicular phase stimulation with PPOS protocol, in oocyte donor patients.
Conditions and MedDRA coding
Volutary women who wish to donate their oocytes
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Age from≥ 18 to ≤ 36 years
- BMI ≥18 to < 28
- Signed informed consent
- Regular menstrual cycle length i.e. 24-35 days
Exclusion criteria 6
- Contraindications to the use of gonadotropins
- Endometriosis grade 3-4
- Patients with AMH <1.1 ng/ml and/or AFC<7
- Patients with FNPO (Follicle Number Per Ovary) ≥ 19 and/or AMH >5ng/ml
- Patients under contraception with hormonal IUD
- Any untreated endocrine abnormality
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Total number of retrieved COCs
Secondary endpoints 5
- Endocrine profile in both treatment groups
- Consumption (mcg) of gonadotrophins
- Duration of ovarian stimulation
- Days of progestin use
- Total number of MII oocytes
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 6
REKOVELLE 12 micrograms/0.36 mL solution for injection in a pre-filled pen
PRD5098647 · Product
- Active substance
- Follitropin Delta
- Substance synonyms
- RFSH
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 12 µg microgram(s)
- Max total dose
- 180 µg microgram(s)
- Max treatment duration
- 15 Day(s)
- Authorisation status
- Authorised
- ATC code
- G03GA10 — -
- Marketing authorisation
- EU/1/16/1150/004
- MA holder
- FERRING PHARMACEUTICALS A/S
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Duphaston 10 mg filmomhulde tabletten
PRD11263823 · Product
- Active substance
- Dydrogesterone
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 200 mg milligram(s)
- Max treatment duration
- 10 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
REKOVELLE 72 micrograms/2.16 mL solution for injection in a pre-filled pen
PRD5098780 · Product
- Active substance
- Follitropin Delta
- Substance synonyms
- RFSH
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 12 µg microgram(s)
- Max total dose
- 180 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
- 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
- 20 mg milligram(s)
- Max total dose
- 200 mg milligram(s)
- Max treatment duration
- 10 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
REKOVELLE 36 micrograms/1.08 mL solution for injection in a pre-filled pen
PRD5098734 · Product
- Active substance
- Follitropin Delta
- Substance synonyms
- RFSH
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 12 µg microgram(s)
- Max total dose
- 180 µg microgram(s)
- Max treatment duration
- 15 Day(s)
- Authorisation status
- Authorised
- ATC code
- G03GA10 — -
- Marketing authorisation
- EU/1/16/1150/005
- MA holder
- FERRING PHARMACEUTICALS A/S
- MA country
- EU
- 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
- 20 mg milligram(s)
- Max total dose
- 200 mg milligram(s)
- Max treatment duration
- 10 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
Universitair Ziekenhuis Brussel
- Sponsor organisation
- Universitair Ziekenhuis Brussel
- Address
- Laarbeeklaan 101
- City
- Jette
- Postcode
- 1090
- Country
- Belgium
Scientific contact point
- Organisation
- Universitair Ziekenhuis Brussel
- Contact name
- Christophe Blockeel
Public contact point
- Organisation
- Universitair Ziekenhuis Brussel
- Contact name
- Elsie Nulens
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 50 | 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 | 2023-02-02 | 2023-02-05 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 15 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_ProtocolV1 2024-513998-48-00 redacted | 1 |
| Protocol (for publication) | D1_ProtocolV2 2024-513998-48-00 redacted | 2 |
| Protocol (for publication) | D1_ProtocolV3_clean_2024-513998-48-00 redacted | 3 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement NA | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults EN-redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults FR-redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults NL-redacted | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Duphaston FR | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Duphaston NL | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Rekovelle FR | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Rekovelle FR | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Rekovelle FR | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Rekovelle NL | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Rekovelle NL | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Rekovelle NL | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-08 | Belgium | Acceptable with conditions 2024-07-31
|
2024-07-31 |