NCT05608590

Brief 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 fertility work-up is completed in women at low risk for tubal pathology.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
554

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2019

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 22, 2019

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

July 18, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 8, 2022

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

May 6, 2023

Status Verified

May 1, 2023

Enrollment Period

6.3 years

First QC Date

July 18, 2022

Last Update Submit

May 5, 2023

Conditions

Female Infertility

Keywords

InfertilityFallopian tubesHysterosalpingographyTubal flushingPregnancyLive birthCost-effectivenessRandomized controlled trial

Outcome Measures

Primary Outcomes (2)

  • Time to live birth

    Calculated from the last menstrual bleeding within 6 months after randomization

    6 months

  • Time to live birth

    Calculated from the last menstrual bleeding within 12 months after randomization

    12 months

Secondary Outcomes (21)

  • Number of live births

    6 months

  • Number of live births

    12 months

  • Number of ongoing pregnancies

    6 and 12 months

  • Number of ongoing pregnancies

    6 months

  • Number of clinical pregnancies

    12 months

  • +16 more secondary outcomes

Study Arms (2)

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

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

Drug: Lipiodol UltraFluid

Interventions

Lipiodol UltraFluidDRUG

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.

Also known as: Oil-based contrast
Delayed HSG 6 months after completing fertility work-upDirect HSG during fertility work-up

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women between 18-39 years of age
  • Spontaneous menstrual cycle
  • Perceived low risk for tubal pathology
  • Undergoing fertility work-up

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amsterdam AMC

Amsterdam, 1081HV, Netherlands

RECRUITING

MeSH Terms

Conditions

Infertility, FemaleInfertility

Interventions

Ethiodized Oil

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Iodized OilPlant OilsOilsLipidsPlant PreparationsBiological ProductsComplex Mixtures

Central Study Contacts

V Mijatovic

CONTACT

+312044444567mijatovic@amsterdamumc.nl

Danah Kamphuis

CONTACT

+312044444567d.kamphuis@amsterdamumc.nl

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 18, 2022

First Posted

November 8, 2022

Study Start

August 22, 2019

Primary Completion

December 1, 2025

Study Completion

January 1, 2026

Last Updated

May 6, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)