Clinical trial • Not applicable • Other
IODIXANOL for Female infertility
Not applicable trial of IODIXANOL for Female infertility.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Female infertility
- Trial Stage
- Not applicable
- Drug Modality
- Diagnostic agent
Key dates
- Initial CTIS Submission Date
- 15-10-2024
- First CTIS Authorization Date
- 29-11-2024
Trial design
Randomised, open-label, group 1: hsg water; group 2: hsg oil (two-arm randomized comparison of water-based versus oil-based contrast during hysterosalpingography).-controlled Not applicable trial across 9 sites in Netherlands.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Group 1: HSG water; Group 2: HSG Oil (two-arm randomized comparison of water-based versus oil-based contrast during hysterosalpingography).
- Target Sample Size
- 499
- Trial Duration For Participant
- 183
Eligibility
Recruits 499 Vulnerable population selected (isVulnerablePopulationSelected: true). Informed consent handled via a subject information and informed consent form document ('SIS and ICF adults'). Participants must be willing and able to sign the consent form (exclusion: "Not willing or able to sign the consent form"). No assent or minor consent procedures are described..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected: true). Informed consent handled via a subject information and informed consent form document ('SIS and ICF adults'). Participants must be willing and able to sign the consent form (exclusion: "Not willing or able to sign the consent form"). No assent or minor consent procedures are described.
Inclusion criteria
- {"criterion_text":"- Ovulation disorders (ovulation disorders will be defined as less than 8 menstrual cycles per year)\n- 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)\n- Above 38 years of age"}
Exclusion criteria
- {"criterion_text":"- Iodine allergy\n- Male subfertility defined as a post-wash total motile sperm count < 1 x10^6 spermatozoa/ml\n- Not willing or able to sign the consent form\n- Endocrine disorders as diabetes, hyperthyroidism or hyperprolactinemia (except for well managed hypothyroidism with TSH between 0.3 and 2.5mIU/l)"}
Endpoints
Primary endpoints
- {"endpoint_text":"- The primary outcome is conception leading to live birth, with a positive pregnancy test preceding the pregnancy within 6 months after randomization.","definition_or_measurement_approach":"Conception leading to live birth, with a positive pregnancy test preceding the pregnancy within 6 months after randomization (endpoint measured as a positive pregnancy test within 6 months post-randomization and resulting live birth)."}
Secondary endpoints
- {"endpoint_text":"- Biochemical pregnancy\n- Clinical pregnancy\n- Ongoing pregnancy\n- Miscarriage\n- Ectopic pregnancy\n- Multiple pregnancy\n- Time to pregnancy\n- Complications following HSG (infection, intravastion)\n- Pregnancy outcomes (f.e. birth weight)\n- Pregnancy complications\n- Stillbirth\n- Thyroid function of the woman (before and 1 month after HSG)\n- Neonatal outcomes\n- Additional fertility treatments (Intra-uterine insemination, IVF, IVF/ICSI)\n- Costs within 6 months after randomization\n- Thyroid function of neonate (determined by heelprick)","definition_or_measurement_approach":"Biochemical pregnancy: as stated. Clinical pregnancy: as stated. Ongoing pregnancy: as stated. Miscarriage: as stated. Ectopic pregnancy: as stated. Multiple pregnancy: as stated. Time to pregnancy: time-to-event measurement for pregnancy. Complications following HSG: e.g. infection, intravasation (as stated). Pregnancy outcomes: e.g. birth weight (as stated). Pregnancy complications: as stated. Stillbirth: as stated. Thyroid function of the woman: measured before and 1 month after HSG. Neonatal outcomes: as stated. Additional fertility treatments: capture use of IUI, IVF, IVF/ICSI. Costs: costs within 6 months after randomization. Thyroid function of neonate: determined by heelprick."}
Recruitment
- Planned Sample Size
- 499
- Recruitment Window Months
- 71
- Consent Approach
- Informed consent obtained from participants using a subject information sheet and informed consent form for adults ('SIS and ICF adults'). Participants must be willing and able to sign the consent form (exclusion: "Not willing or able to sign the consent form"). No details on languages or assent/minor consent provided.
Geography
- Total Number Of Sites
- 9
- Total Number Of Participants
- 499
Netherlands
- Latest Decision Or Authorization Date
- 29-11-2024
- Number Of Sites
- 9
- Number Of Participants
- 499
Sites
- Site Name
- Amsterdam UMC Stichting
- Department Name
- Verloskunde & Gynaecologie
- Contact Person Name
- Velja Mijatovic
- Contact Person Email
- v.mijatovic@amsterdamumc.nl
- Site Name
- Ziekenhuis Amstelland
- Department Name
- gynaecologie
- Contact Person Name
- Alexander Mozes
- Contact Person Email
- almo@zha.nl
- Site Name
- Catharina Ziekenhuis Stichting
- Department Name
- Gynaecologie
- Contact Person Name
- Dana Huppelschoten
- Contact Person Email
- dana.huppelschoten@radboudumc.nl
- Site Name
- Elkerliek Ziekenhuis
- Department Name
- Gynaecologie
- Contact Person Name
- Josien Penninx
- Contact Person Email
- Josien.penninx@elkerliekziekenhuis.nl
- Site Name
- Reinier de Graaf Groep
- Department Name
- gynaecologie
- Contact Person Name
- Evert van Santbrink
- Contact Person Email
- e.vansantbrink@rddg.nl
- Site Name
- Zaans Medisch Centrum Stichting
- Department Name
- Gynaecologie
- Contact Person Name
- Angelo Hooker
- Contact Person Email
- hooker.a@zaansmc.nl
- Site Name
- Universitair Medisch Centrum Groningen
- Department Name
- Gynaecologie
- Contact Person Name
- Marjoleine Dieudonnée Louwerse
- Contact Person Email
- m.d.louwerse@umcg.nl
- Site Name
- Gelre Hospitals
- Department Name
- Gynaecologie
- Contact Person Name
- Maaike Traas
- Contact Person Email
- m.traas@gelre.nl
- Site Name
- Rijnstate Ziekenhuis Stichting
- Department Name
- Gynaecologie
- Contact Person Name
- Annemiek Nap
- Contact Person Email
- anap@rijnstate.nl
Sponsor
Primary sponsor
- Full Name
- Amsterdam UMC Stichting
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Netherlands
Third parties
- {"country":"","full_name":"GUERBET","duties_or_roles":"Monetary support / funder","organisation_type":""}
- {"country":"","full_name":"ZonMW","duties_or_roles":"Monetary support / funder","organisation_type":""}
Investigational products
- Investigational Product Name
- VISIPAQUE 320 mg I/ml, oplossing voor injectie
- Active Substance
- IODIXANOL
- Modality
- Diagnostic agent
- Routes Of Administration
- INTRAUTERINE USE
- Route
- INTRAUTERINE USE
- Authorisation Status
- Authorised (marketing authorisation RVG 17665)
- Maximum Dose
- 50 ml
- Investigational Product Name
- Lipiodol Ultra Fluide, 480 mg I/ml, oplossing voor injectie.
- Active Substance
- ETHYL ESTERS OF IODISED FATTY ACIDS FROM POPPYSEED OIL
- Modality
- Diagnostic agent
- Routes Of Administration
- INTRAUTERINE USE
- Route
- INTRAUTERINE USE
- Authorisation Status
- Authorised (marketing authorisation RVG 02806)
- Maximum Dose
- 15 ml
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