Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruitment ended
Participants planned
736
Countries
1
Sites
14
Infertile women with at least one patent tube at Hysterosalpingo-foam sonography
To determine if the additional tubal flushing with oil-based contrast after undergoing Hyfosy significantly improves the occurrence rate of live birth, counting from the first day of the last menstrual cycle in which the patient conceives within 6 months after Hyfosy compared to no additional flushing after undergoing …
Key facts
- Sponsor
- Antwerp University Hospital
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Phenomena and Processes [G] - Reproductive and Urinary Physiological Phenomena [G08]
- Trial duration
- 12 Jul 2024 → ongoing
- Decision date (initial)
- 2024-07-12
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-508896-35-00
- EudraCT number
- 2020-002135-30
- ClinicalTrials.gov
- NCT04379973
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To determine if the additional tubal flushing with oil-based contrast after undergoing Hyfosy significantly improves the occurrence rate of live birth, counting from the first day of the last menstrual cycle in which the patient conceives within 6 months after Hyfosy compared to no additional flushing after undergoing Hyfosy.
Conditions and MedDRA coding
Infertile women with at least one patent tube at Hysterosalpingo-foam sonography
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Intervention with IMP versus control during Hyfosy Intervention with IMP (Lipiodol Ultra Fluide) versus control during HyFoSy (Hydrosalpingo-Foam-Sonografie)
|
Randomised Controlled | None | Intervention: Administreation of Lipiodol Ultra Fluide Control: No administration of Lipiodol Ultra Fluide |
Regulatory references
- Scientific advice from competent authorities
- Federal Agency For Medicines And Health Products, Commissie Voor Medische Ethiek Zna
- Plan to share IPD
- No
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Infertile women undergoing Hyfosy as part of the fertility workup. Women will be eligible if they (1) are ≥ 18 years and < 40 years
- (2) have infertility defined as: lack of conception despite 12 months of unprotected intercourse OR; if they are taking part in a donor sperm insemination programme: three cycles of donor insemination without pregnancy OR; in case of treated ovulation disorder: three ovulatory ovulation induction cycles without pregnancy
- (3) have tubal patency of at least one Fallopian tube on Hyfosy
Exclusion criteria 10
- known iodine allergy
- allergy to poppy seed oil
- ovulation disorders defined as less than eight menstrual cycles per year who did not have three ovulatory cycles after ovulation induction
- contra-indication to have tubal patency testing according to the site’s indication
- active thyroid disorders
- untreated subclinical hypothyroidism (TSH>2.5mIU/L) in case of auto-immune thyroid disease
- uterine surgery in the past two months before Hyfosy
- a male partner (if applicable) with a post-wash Total Motile Sperm Count (TMC) < 1x106 and/or TMC < 3x106 in the native sperm analysis [TMC is defined as volume X concentration X (A* (progressive) + B* (non progressive) motility in %) divided by 100] OR with a history suspect of severe male factor infertility if no sperm sample is available at time of randomisation (*A+B when A,B,C is used (WHO 2010) A+B+C when A,B,C, D is used (WHO 2021))
- an indication for IVF defined as patients who are advised to go to IVF immediately because of bilateral tubal block, severe male factor infertility, unsolved anovulatory problems, endometriosis with residual functional problems”
- no Belgian national number (RRN/INS)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- the occurrence of live birth, counting from the first day of the last menstrual cycle in which the patient conceives within 6 months after Hyfosy.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Lipiodol Ultra-Fluide, 480 mg I/ml, solution injectable
PRD347943 · Product
- Active substance
- Ethyl Esters of Iodised Fatty Acids From Poppyseed Oil
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAUTERINE USE
- Max daily dose
- 4800 mg milligram(s)
- Max total dose
- 4800 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V08AD01 — ETHYL ESTERS OF IODISED FATTY ACIDS
- Marketing authorisation
- BE017613
- MA holder
- GUERBET
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Antwerp University Hospital
- Sponsor organisation
- Antwerp University Hospital
- Address
- Drie Eikenstraat 655
- City
- Edegem
- Postcode
- 2650
- Country
- Belgium
Scientific contact point
- Organisation
- Antwerp University Hospital
- Contact name
- Diane De Neubourg
Public contact point
- Organisation
- Antwerp University Hospital
- Contact name
- Diane De Neubourg
Locations
1 EU/EEA country · 14 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 736 | 14 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Regional De La Citadelle
Center for Reproductive Medicine, Bld Du Douzieme-De-Ligne 1, 4000, Liege
Ziekenhuis Oost Limburg
Center for Reproductive Medicine, Synaps Park 1, 3600, Genk
CHC MontLegia
Center for Reproductive Medicine, Boulev. De Patience Et Beajonc 2, 4000, Liege
Universitair Ziekenhuis Gent
Center for Reproductive Medicine, Corneel Heymanslaan 10, 9000, Gent
UZ Brussel
Center for Reproductive Medicine, Laarbeeklaan 101, 1090, Jette
Imelda
Center for Reproductive Medicine, Imeldalaan 9, 2820, Bonheiden
Hopital Erasme
Center for Reproductive Medicine, Lennikse Baan 808, 1070, Anderlecht
AZ Turnhout
Center for Reproductive Medicine, Steenweg Op Merksplas 44, 2300, Turnhout
Algemeen Ziekenhuis Klina
Center for Reproductive Medicine, Augustijnslei 100, 2930, Brasschaat
Cliniques Universitaires Saint-Luc
Center for Reproductive Medicine, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Antwerp University Hospital
Center for Reproductive Medicine, Drie Eikenstraat 655, 2650, Edegem
GasthuisZusters Antwerpen
Center for Reproductive Medicine, Oosterveldlaan 24, 2610, Antwerp
Katholieke Universiteit te Leuven
Center for Reproductive Medicine, Herestraat 49, 3000, Leuven
AZ Sint-Lucas & Volkskliniek
Center for Reproductive Medicine, Groenebriel 1, 9000, Gent
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 | 2024-07-12 | 2024-07-12 | 2025-10-29 |
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 2023-508896-35-00 | 4.0 |
| Protocol (for publication) | D1_Protocol_2023-508896-35-00_TC | 4.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements NTF | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF additional DU | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF additional ENG | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF additional FR | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF additional NL | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF initial DU | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF initial ENG | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF initial FR | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF initial NL | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Prescreening DU | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Prescreening ENG | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Prescreening FR | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Prescreening NL | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Initial_DU_2023-508896-35-00_TC | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Initial_ENG_2023-508896-35-00_TC | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Initial_FR_2023-508896-35-00_TC | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Initial_NL_2023-508896-35-00_TC | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Infomration Material Patient brochure_DUI | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Infomration Material Patient brochure_ENG | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Infomration Material Patient brochure_FR | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Infomration Material Patient brochure_NL | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Lipiodol Ultra Fluide | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol Synopsis NL 2023-508896-35-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis DU 2023-508896-35-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis ENG 2023-508896-35-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis FR 2023-508896-35-00 | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-19 | Belgium | Acceptable with conditions 2024-07-08
|
2024-07-12 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-10-04 | Belgium | Acceptable 2024-12-05
|
2024-12-13 |