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)?

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 42
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Netherlands
AmsterdamUMC
RECRUITING
Amsterdam
Contact Information
Primary
Danah Kamphuis, Msc
FOil@amsterdamumc.nl
+312044444567
Backup
Velja Mijatovic, Prof
mijatovic@amsterdamumc.nl
+312044444567
Time Frame
Start Date: 2023-09-22
Estimated Completion Date: 2027-06-01
Participants
Target number of participants: 1102
Treatments
Experimental: Tubal flushing during HSG with oil-based contrast
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.
Active_comparator: Tubal flushing HyFoSy
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.
Related Therapeutic Areas
Sponsors
Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development
Leads: Amsterdam UMC, location VUmc

This content was sourced from clinicaltrials.gov

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