The Cost-effectiveness of Hysterosalpingography Versus Hysterosalpingo-foam Sonography During Fertility Work-up

NCT05882188 | Recruiting DMC

• 1 other identifier: NL83352.018.22
• Study Type: interventional
• Target: 1,102
• Locations: 1 country
• Sites: 1

Brief 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. The hypothesis is that tubal flushing with oil-based contrast during HSG leads to more live births than tubal flushing during HyFoSy.

Conditions

Infertility

Keywords

Hysterosalpingography; Hysterosalpingo Foam Sonography; Infertility work-up; Cost-effectiveness; Live birth; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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.

  within six months after randomization

Secondary Outcomes (10)

• Time to pregnancy leading to live birth

  within six months after randomization

• Number of clinical pregnancies

  within six months after randomization

• Number of miscarriages

  within six months after randomization

• Number of multiple pregnancies

  within six months after randomization

• Number of ectopic pregnancies

  within six months after randomization

Study Arms (2)

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.

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.

Procedure: ExEm Foam

Interventions

Oil-based contrast PROCEDURE

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.

Tubal flushing during HSG with oil-based contrast

ExEm Foam PROCEDURE

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.

Tubal flushing HyFoSy

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (1)

AmsterdamUMC

Amsterdam, Netherlands

RECRUITING

Related Publications (1)

• 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.

  PMID: 39581724 DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Central Study Contacts

Danah Kamphuis, Msc

CONTACT

+312044444567; FOil@amsterdamumc.nl

Velja Mijatovic, Prof

CONTACT

+312044444567; mijatovic@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: May 31, 2023
• Study Start: September 22, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)