Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
300
Countries
1
Sites
1
Subfertility
to compare the probability of having at least one good quality blastocyst after CFA stimulation versus the probability of having at least one good quality blastocyst after a first MNC, in women with a clinical indication for ART and an expected low response to ovarian stimulation. Good quality is defined by the Gardner…
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
- 15 Jul 2022 → ongoing
- Decision date (initial)
- 2024-06-27
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Ghent University Hospital · Organon
External identifiers
- EU CT number
- 2023-509094-23-00
- EudraCT number
- 2021-001835-22
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
to compare the probability of having at least one good quality blastocyst after CFA stimulation versus the probability of having at least one good quality blastocyst after a first MNC, in women with a clinical indication for ART and an expected low response to ovarian stimulation. Good quality is defined by the Gardner score 5AA, 5AB or 5BA.
Secondary objectives 3
- to compare the probability of having at least one good quality blastocyst after CFA stimulation versus the probability of having at least one good quality blastocyst after a second or third MNC, in women with a clinical indication for ART and an expected low response to ovarian stimulation.
- to compare A. One cycle of CFA versus B. two, or up to three MNCs. With respect to - the relative number of blastocysts after ART, relative to the number of oocytes - the probability of having at least one blastocyst of good quality after ART - the probability of having an ongoing pregnancy - the time until ongoing pregnancy in women with a clinical indication for ART and an expected low response to ovarian stimulation.
- to assess AMH and AFC as treatment selection markers to predict ART treatment effects for individual subjects and subsequently help deliver that ART approach to those subjects most likely to benefit from it. For each potential treatment selection marker, we will first explore if there is heterogeneity in the ART effect on the probability of having at least one good quality blastocyst according to baseline AMH/AFC levels. Ideally, cut-offs for serum AMH and/or AFC can be found to classify subjects whom will benefit most from either ART approach (one cycle of CFA or a single MNC / up to two MNCs / up to three MNCs).
Conditions and MedDRA coding
Subfertility
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | two strategies for the management of predicted low prognosis patients under stimulation for IVF/ICSI The study will compare the efficacy of two different strategies for the management of predicted low prognosis patients under stimulation for In Vitro Fertilization (IVF)/IntraCytoplasmic Sperm Injection (ICSI)
|
Randomised Controlled | None | Control group: up to three Modified Natural Cycles (MNC) Intervention group: a single Gonadotropin-Releasing Hormone (GnRH) antagonist corifollitropin alfa (CFA) stimulation |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- women with a clinical indication for ART with an expected low response to ovarian stimulation. Expected low prognosis will be defined according to the POSEIDON classification, which stratifies patients according to whether they have an unexpected (groups 1 and 2) or expected (groups 3 or 4) inappropriate ovarian response to gonadotropin stimulation. This trial only includes patients fulfilling the criteria of groups 3 or 4: • POSEIDON Group 3: patients < 35 years with poor ovarian reserve pre-stimulation parameters (AFC < 5 or AMH < 1.2 ng/ml*) • POSEIDON Group 4: patients ≥ 35 years with poor ovarian reserve pre-stimulation parameters (AFC < 5 or AMH < 1.2 ng/ml*) * AMH value should not be older than 12 months.
- Informed consent form (ICF) dated and signed
- Age ≥ 18 and < 45 years old
- Body Mass Index (BMI) ≥ 18.5 kg/m² and < 35 kg/m²
- Regular menstrual cycles (between 21 and 35 days)
- Two ovaries present
- Current pregnancy-wish
- Single embryo transfer (SET)
Exclusion criteria 9
- Basal FSH > 20 IU/L in the last 12 months
- Simultaneous participation in another clinical study
- Untreated and uncontrolled thyroid dysfunction
- Tumors of the ovary, breast, uterus, pituitary or hypothalamus
- Abnormal (not menstrual) vaginal bleeding without a known/diagnosed cause
- Malformations of the reproductive organs
- Current use of oral contraceptives, anti-psychotics, anti-epileptics or chemotherapy
- Previous antibiotic hypersensitivity reactions (streptomycin and/or neomycin)
- Patients who undergo preimplantation genetic testing (PGT), fertility preservation or oocyte donation
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- the probability of having at least one good quality blastocyst after ART (on the day of embryo transfer) (binary endpoint).
Secondary endpoints 3
- the relative number of blastocyts after ART (on the day of embryo transfer), relative to the number of oocytes (rate)
- the probability of having at least one blastocyst of good quality after ART (on the day of embryo transfer) (binary endpoint)
- the probability of having an ongoing pregnancy which is defined as 6 to 8 weeks gestational age (binary endpoint) o Related sensitivity endpoint:, as confirmed by ultrasound (time to event)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 11
Elonva 150 micrograms solution for injection
PRD9049683 · Product
- Active substance
- Corifollitropin Alfa
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 150 µg microgram(s)
- Max total dose
- 1800 µg microgram(s)
- Max treatment duration
- 6 Month(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
Puregon 900 IU/1.08 mL solution for injection
PRD9022794 · Product
- Active substance
- Follitropin Beta
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 300 IU international unit(s)
- Max total dose
- 54000 IU international unit(s)
- Max treatment duration
- 6 Month(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
Orgalutran 0.25 mg/0.5 mL solution for injection
PRD8889183 · 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
- 37.5 mg milligram(s)
- Max treatment duration
- 6 Month(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
Ovitrelle 250 micrograms/0.5 mL solution for injection in pre-filled syringe
PRD3312178 · Product
- Active substance
- Choriogonadotropin Alfa
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 250 µg microgram(s)
- Max total dose
- 1500 µg microgram(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- G03GA08 — CHORIOGONADOTROPIN ALFA
- Marketing authorisation
- EU/1/00/165/007
- MA holder
- MERCK EUROPE B.V.
- 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
PRD333018 · Product
- Active substance
- Choriogonadotropin Alfa
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 250 µg microgram(s)
- Max total dose
- 1500 µg microgram(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- G03GA08 — CHORIOGONADOTROPIN ALFA
- Marketing authorisation
- EU/1/00/165/007
- MA holder
- MERCK EUROPE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Puregon 150 IU/0.18 mL solution for injection
PRD9022790 · Product
- Active substance
- Follitropin Beta
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 300 IU international unit(s)
- Max total dose
- 54000 IU international unit(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- G03GA06 — FOLLITROPIN BETA
- Marketing authorisation
- EU/1/96/008/040
- MA holder
- N.V. ORGANON
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Ovitrelle 250 micrograms/0.5 mL solution for injection in pre-filled syringe
PRD3312177 · Product
- Active substance
- Choriogonadotropin Alfa
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 250 µg microgram(s)
- Max total dose
- 1500 µg microgram(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- G03GA08 — CHORIOGONADOTROPIN ALFA
- Marketing authorisation
- EU/1/00/165/007
- MA holder
- MERCK EUROPE B.V.
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Puregon 300 IU/0.36 mL solution for injection
PRD9022782 · Product
- Active substance
- Follitropin Beta
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 300 IU international unit(s)
- Max total dose
- 54000 IU international unit(s)
- Max treatment duration
- 6 Month(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
Orgalutran 0.25 mg/0.5 mL solution for injection
PRD8889187 · 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
- 37.5 mg milligram(s)
- Max treatment duration
- 6 Month(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
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
- 250 µg microgram(s)
- Max total dose
- 1500 µg microgram(s)
- Max treatment duration
- 6 Month(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
Puregon 600 IU/0.72 mL solution for injection
PRD9022786 · Product
- Active substance
- Follitropin Beta
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 300 IU international unit(s)
- Max total dose
- 54000 IU international unit(s)
- Max treatment duration
- 6 Month(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
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
- Wijnant Kathleen
Public contact point
- Organisation
- Universitair Ziekenhuis Gent
- Contact name
- Wijnant Kathleen
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 300 | 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 | 2022-07-15 | 2022-07-15 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 28 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_ Protocol 2023-509094-23-00 public | 5.0 |
| Protocol (for publication) | D2_Questionnaire 1A_Dutch_public | 1.0 |
| Protocol (for publication) | D2_Questionnaire 1B_Dutch_public | 1.0 |
| Protocol (for publication) | D2_Questionnaire 2_Dutch_public | 1.0 |
| Protocol (for publication) | D2_Questionnaire 3_Dutch_public | 1.0 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K2_ Recruitment material public | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF adults public | 4.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF adults_Clean_public | 6.0 |
| 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) | L2_ Other subject information material study emergency card | 1.0 |
| Subject information and informed consent form (for publication) | L2_Informed consent procedure | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_ SMPC Elonva | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_ SMPC Orgalutran | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_ SMPC Orgalutran | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_ SmPC Ovitrelle | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_ SmPC Ovitrelle | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_ SmPC Ovitrelle | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_ SmPC Ovitrelle | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_ SmPC Puregon | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_ SmPC Puregon | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_ SmPC Puregon | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_ SmPC Puregon | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis Dutch 2023-509094-23-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis Dutch 2023-509094-23-00_Clean_public | 3.0 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis English 2023-509094-23-00 | 3.0 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis French 2023-509094-23-00_public | 2.0 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis German 2023-509094-23-00_public | 2.0 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-14 | Belgium | Acceptable 2024-06-27
|
2024-06-27 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-02-20 | Belgium | Acceptable 2025-04-28
|
2025-04-28 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-04-29 | Belgium | Acceptable 2025-04-28
|
2026-04-29 |