Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
936
Countries
1
Sites
9
Infertility
Conception leading to live birth, with a positive pregnancy test preceding the pregnancy within 6 months after randomization.
Key facts
- Sponsor
- Amsterdam UMC Stichting
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Trial duration
- 29 Nov 2024 → ongoing
- Decision date (initial)
- 2024-11-29
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- GUERBET · ZonMW
External identifiers
- EU CT number
- 2024-512571-12-00
- EudraCT number
- 2018-004192-12
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis, Safety, Therapy
Conception leading to live birth, with a positive pregnancy test preceding the pregnancy within 6 months after randomization.
Secondary objectives 17
- Biochemical pregnancy
- Clinical pregnancy
- Ongoing pregnancy
- Miscarriage
- Ectopic pregnancy
- Multiple pregnancy
- Time to Event (pregnancy)
- Complications following HSG (infection, intravastion)
- Pregnancy outcomes (f.e. birth weight)
- Pregnancy complications
- Stillbirth
- Thyroid function of the woman (before and 1 month after HSG)
- Neonatal outcomes
- Additional fertility treatments (Intra-uterine insemination, IVF, IVF/ICSI)
- Costs within 6 months after randomization
- Thyroid function of neonate (determined by heelprick)
- Anxiety level prior to HSG
Conditions and MedDRA coding
Infertility
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | LLT | 10016398 | Female infertility | 10038604 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Treatment Phase HSG water vs HSG (Oil)
|
Randomised Controlled | None | Group 1: HSG water Group 2: HSG Oil |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Ovulation disorders (ovulation disorders will be defined as less than 8 menstrual cycles per year)
- High risk for tubal pathology (high risk for tubal pathology will be defined as a positive chlamydia infection, a pelvic inflammatory disease, known endometriosis, abdominal surgery (including tubectomy for ectopic pregnancy and appendectomy) and/or peritonitis in the medical history)
- Above 38 years of age
Exclusion criteria 4
- Iodine allergy
- Male subfertility defined as a post-wash total motile sperm count < 1 x10^6 spermatozoa/ml
- Not willing or able to sign the consent form
- Endocrine disorders as diabetes, hyperthyroidism or hyperprolactinemia (except for well managed hypothyroidism with TSH between 0.3 and 2.5mIU/l)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary outcome is conception leading to live birth, with a positive pregnancy test preceding the pregnancy within 6 months after randomization.
Secondary endpoints 16
- Biochemical pregnancy
- Clinical pregnancy
- Ongoing pregnancy
- Miscarriage
- Ectopic pregnancy
- Multiple pregnancy
- Time to pregnancy
- Complications following HSG (infection, intravastion)
- Pregnancy outcomes (f.e. birth weight)
- Pregnancy complications
- Stillbirth
- Thyroid function of the woman (before and 1 month after HSG)
- Neonatal outcomes
- Additional fertility treatments (Intra-uterine insemination, IVF, IVF/ICSI)
- Costs within 6 months after randomization
- Thyroid function of neonate (determined by heelprick)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
VISIPAQUE 320 mg I/ml, oplossing voor injectie
PRD315617 · Product
- Active substance
- Iodixanol
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAUTERINE USE
- Max daily dose
- 50 ml millilitre(s)
- Max total dose
- 50 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V08AB09 — IODIXANOL
- Marketing authorisation
- RVG 17665
- MA holder
- GE HEALTHCARE B.V.
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Lipiodol Ultra Fluide, 480 mg I/ml, oplossing voor injectie.
PRD6749839 · 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
- 15 ml millilitre(s)
- Max total dose
- 15 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V08AD01 — ETHYL ESTERS OF IODISED FATTY ACIDS
- Marketing authorisation
- RVG 02806
- MA holder
- GUERBET
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Amsterdam UMC Stichting
- Sponsor organisation
- Amsterdam UMC Stichting
- Address
- De Boelelaan 1117
- City
- Amsterdam
- Postcode
- 1081 HV
- Country
- Netherlands
Scientific contact point
- Organisation
- Amsterdam UMC Stichting
- Contact name
- Prof. dr. V. Mijatovic
Public contact point
- Organisation
- Amsterdam UMC Stichting
- Contact name
- Prof. dr. V. Mijatovic
Locations
1 EU/EEA country · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 499 | 9 |
| Rest of world
China, United Kingdom
|
— | 437 | — |
Investigational sites
Amsterdam UMC Stichting
Verloskunde & Gynaecologie, De Boelelaan 1117, 1081 HV, Amsterdam
Ziekenhuis Amstelland
gynaecologie, Laan Van De Helende Meesters 8, 1186 AM, Amstelveen
Elkerliek Ziekenhuis
Gynaecologie, Wesselmanlaan 25, 5707 HA, Helmond
Universitair Medisch Centrum Groningen
Gynaecologie, Hanzeplein 1, 9713 GZ, Groningen
Reinier de Graaf Groep
gynaecologie, Reinier De Graafweg 5, 2625 AD, Delft
Zaans Medisch Centrum Stichting
Gynaecologie, Koningin Julianaplein 58, 1502 DV, Zaandam
Catharina Ziekenhuis Stichting
Gynaecologie, Michelangelolaan 2, 5623 EJ, Eindhoven
Gelre Hospitals
Gynaecologie, Albert Schweitzerlaan 31, 7334 DZ, Apeldoorn
Rijnstate Ziekenhuis Stichting
Gynaecologie, Wagnerlaan 55, 6815 AD, Arnhem
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 |
|---|---|---|---|---|---|
| Netherlands | 2024-11-29 | 2024-11-29 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-512571-12-00 | 1.10 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | SIS and ICF adults | 1.8 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Lipiodol Ultra Fluide | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC VISIPAQUE | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-15 | Netherlands | Acceptable 2024-11-29
|
2024-11-29 |