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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

V Mijatovic contact

+312044444567

mijatovic@amsterdamumc.nl

Danah Kamphuis contact

+312044444567

d.kamphuis@amsterdamumc.nl

Netherlands1 site, 1 recruiting

  • Amsterdam AMC

    Amsterdam, 1081HV

    Velja Mijatovic, mijatovic@amsterdamumc.nl

    Danah Kamphuis, d.kamphuis@amsterdamumc.nl

    Recruiting

Other trials in Netherlands

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.

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 groups in NCT05608590
Study groupRoleWhat they receive
Direct HSG during fertility work-upExperimentalTubal 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-upActive comparatorTubal 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.

  1. Time to live birth

    Calculated from the last menstrual bleeding within 6 months after randomization

    Measured: 6 months

  2. Time to live birth

    Calculated from the last menstrual bleeding within 12 months after randomization

    Measured: 12 months

Secondary outcomes (21)

  1. Number of live births

    Defined as the birth of a live born baby, after 24 weeks gestation

    Measured: 6 months

  2. Number of live births

    Defined as the birth of a live born baby, after 24 weeks gestation

    Measured: 12 months

  3. Number of ongoing pregnancies

    Defined as the presence of a heart beat at 10 to 12 weeks gestation

    Measured: 6 and 12 months

  4. Number of ongoing pregnancies

    Defined as the presence of a heart beat at 10 to 12 weeks gestation

    Measured: 6 months

  5. Number of clinical pregnancies

    Defined as gestational sac detected on ultrasonography

    Measured: 12 months

  6. Number of miscarriages

    Presence of non-vitality on ultrasound or spontaneous loss of pregnancy

    Measured: 6 months

  7. Number of miscarriages

    Presence of non-vitality on ultrasound or spontaneous loss of pregnancy

    Measured: 12 months

  8. Number of ectopic pregnancies

    Embryo implanted outside the uterine cavity

    Measured: 6 months

  9. Number of ectopic pregnancies

    Embryo implanted outside the uterine cavity

    Measured: 12 months

  10. Number of multiple pregnancies

    Pregnancy of two or more foetuses

    Measured: 6 months

  11. Number of multiple pregnancies

    Pregnancy of two or more foetuses

    Measured: 12 months

  12. Number of complication after HSG

    e.g. intravasation or infection

    Measured: One month after HSG

  13. Number of pregnancy complications

    e.g. pre-term birth, hypertension

    Measured: 6 months

  14. Number of pregnancy complications

    e.g. pre-term birth, hypertension

    Measured: 12 months

  15. Number of still births

    Death or loss of the baby before or during

    Measured: 12 months

  16. Number of still births

    Death or loss of the baby before or during

    Measured: 6 months

  17. Incidence of thyroid dysfunction after HSG

    TSH and fT4 measurement (blood test)

    Measured: One month after HSG

  18. Number of cycles of artificial reproductive techniques

    Number of cycles of IUI and IVF/ICSI

    Measured: 6 and 12 months

  19. Number of cycles of artificial reproductive techniques

    Number of cycles of IUI and IVF/ICSI

    Measured: 6 months

  20. Number of cycles of artificial reproductive techniques

    Number of cycles of IUI and IVF/ICSI

    Measured: 12 months

  21. 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.

  1. First posted8 Nov 2022
  2. Study start22 Aug 2019
  3. Primary completion1 Dec 2025 (estimated)
  4. Study completion1 Jan 2026 (estimated)

Resources

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)
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

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?

On the ClinicalTrials.gov record for NCT05608590.

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.

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