InfertilityFOilNCT05882188
The Cost-effectiveness of Hysterosalpingography Versus Hysterosalpingo-foam Sonography During Fertility Work-up
A study testing Oil-based contrast and ExEm Foam in people with Infertility, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial summary
Hysterosalpingography (HSG) and hysterosalpingo-foam sonography are two methods to assess tubal patency during fertility work-up. This study aims to investigate the effectiveness of tubal flushing with oil-based contrast during HSG compared to tubal flushing during HyFoSy in women undergoing fertility work-up. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Oil-based contrast and ExEm Foam
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,102 participants
- Where
- 1 siteNetherlands
- Study dates
- 22 Sep 2023to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Infertile women or women with oligo-or anovulation
- Indication for tubal patency testing during the fertility work-up
- Sufficient understanding of the Dutch or English language
- Signed informed consent
Who cannot join
- Severe male factor with a total motile sperm count <3x106ml (pre-washed)
- Known contrast (iodine) allergy
- Women who have had a gynecologic procedure within the last 30 days
- Women with known or suspected reproductive tract neoplasia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
AmsterdamUMC
Amsterdam
Danah Kamphuis, FOil@amsterdamumc.nl
About this study
Official title: Is, in Infertile Women Undergoing a Basic Fertility Work-up, Tubal Flushing With Oil-based Contrast Medium During Hysterosalpingography (HSG) Cost-effective Compared to Tubal Flushing by Hysterosalpingo-foam Sonography (HyFoSy)?
Hysterosalpingography (HSG) and hysterosalpingo-foam sonography are two methods to assess tubal patency during fertility work-up. This study aims to investigate the effectiveness of tubal flushing with oil-based contrast during HSG compared to tubal flushing during HyFoSy in women undergoing fertility work-up. The hypothesis is that tubal flushing with oil-based contrast during HSG leads to more live births than tubal flushing during HyFoSy.
Read the detailed description
Background: The diagnostic work-up for infertility generally includes estimating the risk for tubal pathology and if indicated assessing tubal patency. Traditionally, tubal patency testing during the fertility work-up is performed with hysterosalpingography (HSG). In previous studies it has been demonstrated that tubal flushing with oil-based contrast during HSG resulted in more ongoing pregnancies than when HSG is performed with water-based contrast. HyFoSy is a more patient friendly alternative for HSG. Up till now, the fertility enhancing effect of tubal flushing with ExEm Foam during HyFoSy has only been studied in relatively small and observational studies.
Objectives:The main objective of this study is to determine whether tubal flushing with oil-based contrast during HSG results into more pregnancies leading to live births when compared to tubal flushing with ExEm Foam during HyFoSy, and whether this approach is cost-effective. In this study the safety of both strategies will also be compared.
Rationale: The hypothesis is that tubal flushing with oil-based contrast during HSG leads to more live births compared to tubal flushing with ExEm Foam during HyFoSy in women with an indication for tubal patency testing. If more live births are achieved, expensive fertility treatments will be less needed, which makes tubal flushing with oil-based contrast during HSG a cost-effective strategy.
Study design: This study is a multicenter randomized controlled trial with an economic analysis alongside it. Women with indication for tubal patency testing will be randomized to tubal flushing with oil-based contrast during HSG and tubal flushing with ExEm Foam during HyFoSy.
- Conditions
- Infertility
- Being tested
- Oil-based contrast, ExEm Foam
- Keywords
- Hysterosalpingography, Hysterosalpingo Foam Sonography, Infertility work-up, Cost-effectiveness, Live birth, Randomized controlled trial
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oil-based contrastProcedure or surgery
oil-based contrast fluid, Lipiodol Ultra Fluid. Lipiodol is a solution of iodinated ethyl esters of fatty acids of poppyseed oil. Equivalent to 480 mg iodine per ml. The maximum dosage is 15ml. Lipiodol is produced by Guerbet, France. Lipiodol is FDA approved and registered as contrast agent for HSG.
ExEm FoamProcedure or surgery
ExEm Foam which is created by mixing 5ml ExEm-gel and 5ml of purified water. ExEm-gel contains hydroxyethylcellulose and glycerol. The ExEm Foam is distributed by IQ Medical Ventures, the Netherlands. ExEm Foam is FDA approved, CE marked and registered as contrast agent for HyFoSy.
| Study group | Role | What they receive |
|---|---|---|
| Tubal flushing during HSG with oil-based contrast | Experimental | Tubal flushing during HSG HSG will be performed by a gynaecologist, fertility doctor or nurse according to local protocols. HSG will be performed in the follicular phase of the cycle. Preferably, HSG is performed in the next cycle after randomization, but if this is not feasible the procedure may be postponed up till one month after randomization. After cleaning the vagina and cervix, a vacuum cervix adapter will be applied to the cervix or a Lipiodol resistant balloon catheter or hysterophore will be placed through the cervix. Up to 15ml of Lipiodol Ultra Fluid will be injected into the uterine cavity and its spread directly monitored by fluoroscopy. Six to eight radiographs will be taken and assessed by a gynaecologist or radiologist. The maximum amount of oil-based contrast medium is set at 15ml. Receives: Procedure: Oil-based contrast |
| Tubal flushing HyFoSy | Active comparator | Tubal flushing during HyFoSy will be performed by a gynaecologist, fertility doctor, sonographer or nurse according to local protocols. HyFoSy will be performed in the follicular phase of the cycle. Preferably, HyFosy is performed in the next cycle after randomization, but if this is not feasible the procedure may be postponed up till one month after randomization. During HyFoSy approximately 5-10cc of foam will be introduced through a little cervical balloon-less applicator into the uterine cavity. During infusion of the foam into the uterine cavity, a transvaginal ultrasound will be performed which shows whether the Fallopian tubes are patent. The assessment of the procedure will be done by the one who performed the procedure. Receives: Procedure: ExEm Foam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of pregnancies leading to live birth.
Pregnancy is defined as a positive pregnancy test, increase in human chorionic gonadotropin (HCG) level or a pregnancy shown on ultrasonographic examination. Live birth is defined as the birth of live baby born beyond 24 weeks of pregnancy.
Measured: within six months after randomization
Secondary outcomes (10)
Time to pregnancy leading to live birth
Calculated from the day of randomization till the first day of the last menstrual bleeding before a positive pregnancy test.
Measured: within six months after randomization
Number of clinical pregnancies
Clinical pregnancy is defined as gestational sac with or without heartbeat visible on ultrasound.
Measured: within six months after randomization
Number of miscarriages
Miscarriage is defined as presence of non-vitality on ultrasound or spontaneous loss off pregnancy
Measured: within six months after randomization
Number of multiple pregnancies
Multiple pregnancy is defined as two or more vital intrauterine pregnancies at 12 weeks gestation.
Measured: within six months after randomization
Number of ectopic pregnancies
Ectopic pregnancy is defined as no intrauterine gestational sac with: an ectopic gestational sac OR HCG concentration >1500 international units per liter (IU/L) with free fluid/ectopic mass on ultrasound or serum HCG >2000IU/L without free fluid/ectopic mass on ultrasound
Measured: within six months after randomization
Number of adverse events
e.g. infection, intravasation, thyroid dysfunction
Measured: within one months after tubal patency testing
Procedural pain scores
measured by Visual Analogue Scale (VAS) on a scale from 0.0 to 10.0 centimeter immediately after tubal patency testing.
Measured: Within 15 minutes after tubal patency testing
Number of fertility treatment cycles
e.g. intra uterine insemination, in vitro fertilization, intracytoplasmatic sperm injection
Measured: within six months after randomization
Number of pregnancy complications
e.g. pregnancy induced hypertension, fetal growth restriction, still birth.
Measured: within six months after randomization
Cost-effectiveness
Comparing the costs (including costs for tubal patency testing and additional fertility treatments) and the effects (chance of live birth)
Measured: within six months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start22 Sep 2023
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,102 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
- NCT05882188
- Sponsor's protocol ID
- NL83352.018.22
- Acronym
- FOil
- Status last verified
- Apr 2024
- First submitted
- 5 May 2023
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kamphuis D, Huijser JPM, van Welie N, Verhoeve HR, Kuijper E, de Bruin JP, van Dongen AJCM, Gielen SCJP, de Krom G, Janse F, Koks CAM, Nap AW, Anema JR, Bosmans JE, Stoker J, van Wely M, Mol BWJ, Mijatovic V, Dreyer K. Tubal flushing with oil-based contrast during hysterosalpingography versus tubal flushing by hysterosalpingo-foam sonography in infertile women undergoing fertility work-up: study protocol of a randomised controlled trial (FOil study). BMJ Open. 2024 Nov 24;14(11):e091778. doi: 10.1136/bmjopen-2024-091778.
PubMed 39581724
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is, in Infertile Women Undergoing a Basic Fertility Work-up, Tubal Flushing With Oil-based Contrast Medium During Hysterosalpingography (HSG) Cost-effective Compared to Tubal Flushing by Hysterosalpingo-foam Sonography (HyFoSy)?
- ClinicalTrials.gov ID
- NCT05882188
- Acronym / sponsor ID
- FOil / NL83352.018.22
- Conditions
- Infertility
- Keywords
- Hysterosalpingography, Hysterosalpingo Foam Sonography, Infertility work-up, Cost-effectiveness, Live birth, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,102 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 22 Sep 2023 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 31 May 2023 (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.
Hysterosalpingography (HSG) and hysterosalpingo-foam sonography are two methods to assess tubal patency during fertility work-up. This study aims to investigate the effectiveness of tubal flushing with oil-based contrast during HSG compared to tubal flushing during HyFoSy in women undergoing fertility work-up. The hypothesis is that tubal flushing with oil-based contrast during HSG leads to more live births than tubal flushing during HyFoSy.
Detailed description
Background: The diagnostic work-up for infertility generally includes estimating the risk for tubal pathology and if indicated assessing tubal patency. Traditionally, tubal patency testing during the fertility work-up is performed with hysterosalpingography (HSG). In previous studies it has been demonstrated that tubal flushing with oil-based contrast during HSG resulted in more ongoing pregnancies than when HSG is performed with water-based contrast. HyFoSy is a more patient friendly alternative for HSG. Up till now, the fertility enhancing effect of tubal flushing with ExEm Foam during HyFoSy has only been studied in relatively small and observational studies.
Objectives:The main objective of this study is to determine whether tubal flushing with oil-based contrast during HSG results into more pregnancies leading to live births when compared to tubal flushing with ExEm Foam during HyFoSy, and whether this approach is cost-effective. In this study the safety of both strategies will also be compared.
Rationale: The hypothesis is that tubal flushing with oil-based contrast during HSG leads to more live births compared to tubal flushing with ExEm Foam during HyFoSy in women with an indication for tubal patency testing. If more live births are achieved, expensive fertility treatments will be less needed, which makes tubal flushing with oil-based contrast during HSG a cost-effective strategy.
Study design: This study is a multicenter randomized controlled trial with an economic analysis alongside it. Women with indication for tubal patency testing will be randomized to tubal flushing with oil-based contrast during HSG and tubal flushing with ExEm Foam during HyFoSy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tubal flushing during HSG with oil-based contrast | Experimental | Procedure: Oil-based contrastTubal flushing during HSG HSG will be performed by a gynaecologist, fertility doctor or nurse according to local protocols. HSG will be performed in the follicular phase of the cycle. Preferably, HSG is performed in the next cycle after randomization, but if this is not feasible the procedure may be postponed up till one month after randomization. After cleaning the vagina and cervix, a vacuum cervix adapter will be applied to the cervix or a Lipiodol resistant balloon catheter or hysterophore will be placed through the cervix. Up to 15ml of Lipiodol Ultra Fluid will be injected into the uterine cavity and its spread directly monitored by fluoroscopy. Six to eight radiographs will be taken and assessed by a gynaecologist or radiologist. The maximum amount of oil-based contrast medium is set at 15ml. |
| Tubal flushing HyFoSy | Active comparator | Procedure: ExEm FoamTubal flushing during HyFoSy will be performed by a gynaecologist, fertility doctor, sonographer or nurse according to local protocols. HyFoSy will be performed in the follicular phase of the cycle. Preferably, HyFosy is performed in the next cycle after randomization, but if this is not feasible the procedure may be postponed up till one month after randomization. During HyFoSy approximately 5-10cc of foam will be introduced through a little cervical balloon-less applicator into the uterine cavity. During infusion of the foam into the uterine cavity, a transvaginal ultrasound will be performed which shows whether the Fallopian tubes are patent. The assessment of the procedure will be done by the one who performed the procedure. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Infertile women or women with oligo-or anovulation
- Indication for tubal patency testing during the fertility work-up
- Sufficient understanding of the Dutch or English language
- Signed informed consent
Key exclusion criteria (4 listed)
- Severe male factor with a total motile sperm count <3x106ml (pre-washed)
- Known contrast (iodine) allergy
- Women who have had a gynecologic procedure within the last 30 days
- Women with known or suspected reproductive tract neoplasia
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 |
|---|---|---|
| Oil-based contrastoil-based contrast fluid, Lipiodol Ultra Fluid. Lipiodol is a solution of iodinated ethyl esters of fatty acids of poppyseed oil. Equivalent to 480 mg iodine per ml. The maximum dosage is 15ml. Lipiodol is produced by Guerbet, France. Lipiodol is FDA approved and registered as contrast agent for HSG. | Procedure or surgery | Tubal flushing during HSG with oil-based contrast |
| ExEm FoamExEm Foam which is created by mixing 5ml ExEm-gel and 5ml of purified water. ExEm-gel contains hydroxyethylcellulose and glycerol. The ExEm Foam is distributed by IQ Medical Ventures, the Netherlands. ExEm Foam is FDA approved, CE marked and registered as contrast agent for HyFoSy. | Procedure or surgery | Tubal flushing HyFoSy |
Primary outcome
Number of pregnancies leading to live birth.
Time frame: within six months after randomization
Pregnancy is defined as a positive pregnancy test, increase in human chorionic gonadotropin (HCG) level or a pregnancy shown on ultrasonographic examination. Live birth is defined as the birth of live baby born beyond 24 weeks of pregnancy.
10 secondary outcomes
Time to pregnancy leading to live birth
Time frame: within six months after randomization
Number of clinical pregnancies
Time frame: within six months after randomization
Number of miscarriages
Time frame: within six months after randomization
Number of multiple pregnancies
Time frame: within six months after randomization
Number of ectopic pregnancies
Time frame: within six months after randomization
Number of adverse events
Time frame: within one months after tubal patency testing
Procedural pain scores
Time frame: Within 15 minutes after tubal patency testing
Number of fertility treatment cycles
Time frame: within six months after randomization
Number of pregnancy complications
Time frame: within six months after randomization
Cost-effectiveness
Time frame: within six months after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Derived from this study: PubMed 39581724Kamphuis D, Huijser JPM, van Welie N, Verhoeve HR, Kuijper E, de Bruin JP, van Dongen AJCM, Gielen SCJP, de Krom G, Janse F, Koks CAM, Nap AW, Anema JR, Bosmans JE, Stoker J, van Wely M, Mol BWJ, Mijatovic V, Dreyer K. Tubal flushing with oil-based contrast during hysterosalpingography versus tubal flushing by hysterosalpingo-foam sonography in infertile women undergoing fertility work-up: study protocol of a randomised controlled trial (FOil study). BMJ Open. 2024 Nov 24;14(11):e091778. doi: 10.1136/bmjopen-2024-091778.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oil-based contrast and ExEm Foam in people with 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 4 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: looking for participants now, as of the sponsor's last update on 24 Apr 2024. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Danah Kamphuis, Msc (+312044444567, FOil@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of pregnancies leading to live birth. (time frame: within six months after randomization). 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 NCT05882188, which also lists 1 linked publication.
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 24 Apr 2024.