Female InfertilityPhase 4H2Oil-timingNCT05608590
What is the Best Moment for Performing an HSG in Women With a Unfulfilled Childwish
A Phase 4 study testing Lipiodol UltraFluid in people with Female Infertility, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial summary
The aim of this study is to determine whether direct tubal flushing with oil-based contrast at HSG incorporated in the fertility work-up results in 10% more ongoing pregnancies and a shorter time to pregnancy, which will therefore be effective and cost-effective compared to delayed tubal flushing 6 months after… Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Female Infertility
- What is being tested?
- Lipiodol UltraFluid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 554 participants
- Where
- 1 siteNetherlands
- Study dates
- 22 Aug 2019to 1 Jan 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women between 18-39 years of age
- Spontaneous menstrual cycle
- Perceived low risk for tubal pathology
- Undergoing fertility work-up
Who cannot join
- Women with known endocrine disorders (e.g. the polycystic ovary syndrome, diabetes, hyperthyroidism and hyperprolactinemia. Except for well managed hypothyroidism with TSH between 0.3 and 2.5mIU/l)
- Ovulation disorders defined as less than eight menstrual cycles per year
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam AMC
Amsterdam, 1081HV
Velja Mijatovic, mijatovic@amsterdamumc.nl
Danah Kamphuis, d.kamphuis@amsterdamumc.nl
About this study
Official title: Tubal Flushing With Oil-based Contrast During HSG in Subfertile Women: Is Early Flushing Effective and Cost-effective as Compared to Delayed Flushing? - H2Oil-timing Study
The aim of this study is to determine whether direct tubal flushing with oil-based contrast at HSG incorporated in the fertility work-up results in 10% more ongoing pregnancies and a shorter time to pregnancy, which will therefore be effective and cost-effective compared to delayed tubal flushing 6 months after fertility work-up is completed in women at low risk for tubal pathology.
Read the detailed description
Rationale: The investigators hypothesize that direct tubal flushing with oil-based contrast at HSG incorporated in the fertility work-up results in 10% more ongoing pregnancies and a shorter time to pregnancy compared to delayed tubal flushing 6 months after fertility work-up is completed in women at low risk for tubal pathology, which will lead to a reduction in the need for expensive fertility treatments like IVF and/or ICSI, and will therefore be an effective and cost effective strategy.
Objective: The aim of this study is to determine whether direct tubal flushing with oil-based contrast at HSG incorporated in the fertility work-up results in 10% more ongoing pregnancies and a shorter time to pregnancy, which will therefore be effective and cost-effective compared to delayed tubal flushing 6 months after fertility work-up is completed in women at low risk for tubal pathology.
Study design: The investigators plan a multicentre randomized controlled trial with an economic analysis alongside it. Infertile women at low risk for tubal pathology will be randomized to direct tubal flushing with oil-based contrast incorporated in the fertility work-up or delayed tubal flushing 6 months after fertility work-up is completed.
Study population: Infertile women 18-38 years of age, who have a spontaneous menstrual cycle and at low risk for tubal pathology, undergoing fertility work-up.
Intervention (if applicable): Direct tubal flushing with oil-based contrast at HSG as part of the fertility work-up compared to delayed tubal flushing 6 months after the fertility work-up is completed.
Main study parameters/endpoints: The primary outcome is time to live birth, calculated from positive pregnancy test and within 12 months after randomization.
Our hypothesis is that tubal flushing at HSG with oil-based contrast incorporated in the fertility work-up will result in 10% more ongoing pregnancies and a shorter time to pregnancy, and thus reducing the need for ART and reducing costs.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: As two strategies are compared (tubal flushing with oil-based contrast at HSG incorporated in the fertility work-up versus 6 months after completion of fertility work-up) that are already applied in current practice, no additional risks or burdens are expected from the study.
- Conditions
- Female Infertility
- Being tested
- Lipiodol UltraFluid
- Keywords
- Infertility, Fallopian tubes, Hysterosalpingography, Tubal flushing, Pregnancy, Live birth, Cost-effectiveness, Randomized controlled trial
- Medical subject headings
- Infertility, Female, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipiodol UltraFluidDrug
Also called Oil-based contrast
The investigational product is an oil-based contrast medium, Lipiodol® (Guerbet). Lipiodol® is a solution of ethyl esters of iodized fatty acids of poppy seed oil equivalent to 480mg I /ml and is a licensed contrast agent in the Netherlands (RVG 02806, see SmPC D2). The maximum amount of Lipiodol® per HSG procedure is 15 ml.
| Study group | Role | What they receive |
|---|---|---|
| Direct HSG during fertility work-up | Experimental | Tubal flushing at HSG with Lipiodol® (oil-based contrast medium) (max. 15mL) incorporated in the fertility work-up Receives: Drug: Lipiodol UltraFluid |
| Delayed HSG 6 months after completing fertility work-up | Active comparator | Tubal flushing at HSG with Lipiodol® (oil-based contrast medium) (max. 15mL) after a 6 months waiting period after completion of fertility work-up Receives: Drug: Lipiodol UltraFluid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to live birth
Calculated from the last menstrual bleeding within 6 months after randomization
Measured: 6 months
Time to live birth
Calculated from the last menstrual bleeding within 12 months after randomization
Measured: 12 months
Secondary outcomes (21)
Number of live births
Defined as the birth of a live born baby, after 24 weeks gestation
Measured: 6 months
Number of live births
Defined as the birth of a live born baby, after 24 weeks gestation
Measured: 12 months
Number of ongoing pregnancies
Defined as the presence of a heart beat at 10 to 12 weeks gestation
Measured: 6 and 12 months
Number of ongoing pregnancies
Defined as the presence of a heart beat at 10 to 12 weeks gestation
Measured: 6 months
Number of clinical pregnancies
Defined as gestational sac detected on ultrasonography
Measured: 12 months
Number of miscarriages
Presence of non-vitality on ultrasound or spontaneous loss of pregnancy
Measured: 6 months
Number of miscarriages
Presence of non-vitality on ultrasound or spontaneous loss of pregnancy
Measured: 12 months
Number of ectopic pregnancies
Embryo implanted outside the uterine cavity
Measured: 6 months
Number of ectopic pregnancies
Embryo implanted outside the uterine cavity
Measured: 12 months
Number of multiple pregnancies
Pregnancy of two or more foetuses
Measured: 6 months
Number of multiple pregnancies
Pregnancy of two or more foetuses
Measured: 12 months
Number of complication after HSG
e.g. intravasation or infection
Measured: One month after HSG
Number of pregnancy complications
e.g. pre-term birth, hypertension
Measured: 6 months
Number of pregnancy complications
e.g. pre-term birth, hypertension
Measured: 12 months
Number of still births
Death or loss of the baby before or during
Measured: 12 months
Number of still births
Death or loss of the baby before or during
Measured: 6 months
Incidence of thyroid dysfunction after HSG
TSH and fT4 measurement (blood test)
Measured: One month after HSG
Number of cycles of artificial reproductive techniques
Number of cycles of IUI and IVF/ICSI
Measured: 6 and 12 months
Number of cycles of artificial reproductive techniques
Number of cycles of IUI and IVF/ICSI
Measured: 6 months
Number of cycles of artificial reproductive techniques
Number of cycles of IUI and IVF/ICSI
Measured: 12 months
Neonatal thyroid dysfunction
Screening on congenital thyroid dysfunction postpartum
Measured: Within one week after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start22 Aug 2019
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female InfertilityStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 554 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Principal investigator, Prof. Velja Mijatovic, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05608590
- Sponsor's protocol ID
- NL62838.029.18
- Other IDs
- 2018.004153.24, NL7926, 2018
- Acronym
- H2Oil-timing
- Status last verified
- May 2023
- First submitted
- 18 Jul 2022
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tubal Flushing With Oil-based Contrast During HSG in Subfertile Women: Is Early Flushing Effective and Cost-effective as Compared to Delayed Flushing? - H2Oil-timing Study
- ClinicalTrials.gov ID
- NCT05608590
- Acronym / sponsor ID
- H2Oil-timing / NL62838.029.18
- Conditions
- Female Infertility
- Keywords
- Infertility, Fallopian tubes, Hysterosalpingography, Tubal flushing, Pregnancy, Live birth, Cost-effectiveness, Randomized controlled trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 554 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 22 Aug 2019 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 8 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to determine whether direct tubal flushing with oil-based contrast at HSG incorporated in the fertility work-up results in 10% more ongoing pregnancies and a shorter time to pregnancy, which will therefore be effective and cost-effective compared to delayed tubal flushing 6 months after fertility work-up is completed in women at low risk for tubal pathology.
Detailed description
Rationale: The investigators hypothesize that direct tubal flushing with oil-based contrast at HSG incorporated in the fertility work-up results in 10% more ongoing pregnancies and a shorter time to pregnancy compared to delayed tubal flushing 6 months after fertility work-up is completed in women at low risk for tubal pathology, which will lead to a reduction in the need for expensive fertility treatments like IVF and/or ICSI, and will therefore be an effective and cost effective strategy.
Objective: The aim of this study is to determine whether direct tubal flushing with oil-based contrast at HSG incorporated in the fertility work-up results in 10% more ongoing pregnancies and a shorter time to pregnancy, which will therefore be effective and cost-effective compared to delayed tubal flushing 6 months after fertility work-up is completed in women at low risk for tubal pathology.
Study design: The investigators plan a multicentre randomized controlled trial with an economic analysis alongside it. Infertile women at low risk for tubal pathology will be randomized to direct tubal flushing with oil-based contrast incorporated in the fertility work-up or delayed tubal flushing 6 months after fertility work-up is completed.
Study population: Infertile women 18-38 years of age, who have a spontaneous menstrual cycle and at low risk for tubal pathology, undergoing fertility work-up.
Intervention (if applicable): Direct tubal flushing with oil-based contrast at HSG as part of the fertility work-up compared to delayed tubal flushing 6 months after the fertility work-up is completed.
Main study parameters/endpoints: The primary outcome is time to live birth, calculated from positive pregnancy test and within 12 months after randomization.
Our hypothesis is that tubal flushing at HSG with oil-based contrast incorporated in the fertility work-up will result in 10% more ongoing pregnancies and a shorter time to pregnancy, and thus reducing the need for ART and reducing costs.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: As two strategies are compared (tubal flushing with oil-based contrast at HSG incorporated in the fertility work-up versus 6 months after completion of fertility work-up) that are already applied in current practice, no additional risks or burdens are expected from the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Direct HSG during fertility work-up | Experimental | Drug: Lipiodol UltraFluidTubal flushing at HSG with Lipiodol® (oil-based contrast medium) (max. 15mL) incorporated in the fertility work-up |
| Delayed HSG 6 months after completing fertility work-up | Active comparator | Drug: Lipiodol UltraFluidTubal flushing at HSG with Lipiodol® (oil-based contrast medium) (max. 15mL) after a 6 months waiting period after completion of fertility work-up |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women between 18-39 years of age
- Spontaneous menstrual cycle
- Perceived low risk for tubal pathology
- Undergoing fertility work-up
Key exclusion criteria (5 listed)
- Women with known endocrine disorders (e.g. the polycystic ovary syndrome, diabetes, hyperthyroidism and hyperprolactinemia. Except for well managed hypothyroidism with TSH between 0.3 and 2.5mIU/l)
- Ovulation disorders defined as less than eight menstrual cycles per year
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lipiodol UltraFluidAlso: Oil-based contrastThe investigational product is an oil-based contrast medium, Lipiodol® (Guerbet). Lipiodol® is a solution of ethyl esters of iodized fatty acids of poppy seed oil equivalent to 480mg I /ml and is a licensed contrast agent in the Netherlands (RVG 02806, see SmPC D2). The maximum amount of Lipiodol® per HSG procedure is 15 ml. | Drug | Delayed HSG 6 months after completing fertility work-up, Direct HSG during fertility work-up |
Primary outcome
Time to live birth
Time frame: 6 months
Calculated from the last menstrual bleeding within 6 months after randomization
Time to live birth
Time frame: 12 months
Calculated from the last menstrual bleeding within 12 months after randomization
21 secondary outcomes
Number of live births
Time frame: 6 months
Number of live births
Time frame: 12 months
Number of ongoing pregnancies
Time frame: 6 and 12 months
Number of ongoing pregnancies
Time frame: 6 months
Number of clinical pregnancies
Time frame: 12 months
Number of miscarriages
Time frame: 6 months
Number of miscarriages
Time frame: 12 months
Number of ectopic pregnancies
Time frame: 6 months
Number of ectopic pregnancies
Time frame: 12 months
Number of multiple pregnancies
Time frame: 6 months
Number of multiple pregnancies
Time frame: 12 months
Number of complication after HSG
Time frame: One month after HSG
Number of pregnancy complications
Time frame: 6 months
Number of pregnancy complications
Time frame: 12 months
Number of still births
Time frame: 12 months
Number of still births
Time frame: 6 months
Incidence of thyroid dysfunction after HSG
Time frame: One month after HSG
Number of cycles of artificial reproductive techniques
Time frame: 6 and 12 months
Number of cycles of artificial reproductive techniques
Time frame: 6 months
Number of cycles of artificial reproductive techniques
Time frame: 12 months
Neonatal thyroid dysfunction
Time frame: Within one week after birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lipiodol UltraFluid in people with Female Infertility, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact V Mijatovic (+312044444567, mijatovic@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to live birth (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023; AzTrials last refreshed its copy on 7 Nov 2026.