What is the Best Moment for Performing an HSG in Women With a Unfulfilled Childwish

Female Infertility Clinical Trial

— H2Oil-timing  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05608590
• Other study ID #: NL62838.029.18
• Secondary ID: 2018.004153.24NL
• Status: Recruiting
• Phase: Phase 4
• Start date: August 22, 2019
• Est. completion date: January 1, 2026

Study information

• Verified date: May 2023
• Source: Amsterdam UMC, location VUmc
• Contact: V Mijatovic
• Phone: +312044444567
• Email: mijatovic[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 554
• Est. completion date: January 1, 2026
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

Inclusion Criteria:

• Women between 18-39 years of age

• Spontaneous menstrual cycle

• Perceived low risk for tubal pathology

• Undergoing fertility work-up

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Female Infertility
• Flushing
• Infertility
• Infertility, Female

Intervention

Drug:
• Lipiodol UltraFluid
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.

Locations

Country	Name	City	State
Netherlands	Amsterdam AMC	Amsterdam

Sponsors (2)

Lead Sponsor	Collaborator
Amsterdam UMC, location VUmc	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to live birth	Calculated from the last menstrual bleeding within 6 months after randomization	6 months
Primary	Time to live birth	Calculated from the last menstrual bleeding within 12 months after randomization	12 months
Secondary	Number of live births	Defined as the birth of a live born baby, after 24 weeks gestation	6 months
Secondary	Number of live births	Defined as the birth of a live born baby, after 24 weeks gestation	12 months
Secondary	Number of ongoing pregnancies	Defined as the presence of a heart beat at 10 to 12 weeks gestation	6 and 12 months
Secondary	Number of ongoing pregnancies	Defined as the presence of a heart beat at 10 to 12 weeks gestation	6 months
Secondary	Number of clinical pregnancies	Defined as gestational sac detected on ultrasonography	12 months
Secondary	Number of miscarriages	Presence of non-vitality on ultrasound or spontaneous loss of pregnancy	6 months
Secondary	Number of miscarriages	Presence of non-vitality on ultrasound or spontaneous loss of pregnancy	12 months
Secondary	Number of ectopic pregnancies	Embryo implanted outside the uterine cavity	6 months
Secondary	Number of ectopic pregnancies	Embryo implanted outside the uterine cavity	12 months
Secondary	Number of multiple pregnancies	Pregnancy of two or more foetuses	6 months
Secondary	Number of multiple pregnancies	Pregnancy of two or more foetuses	12 months
Secondary	Number of complication after HSG	e.g. intravasation or infection	One month after HSG
Secondary	Number of pregnancy complications	e.g. pre-term birth, hypertension	6 months
Secondary	Number of pregnancy complications	e.g. pre-term birth, hypertension	12 months
Secondary	Number of still births	Death or loss of the baby before or during	12 months
Secondary	Number of still births	Death or loss of the baby before or during	6 months
Secondary	Incidence of thyroid dysfunction after HSG	TSH and fT4 measurement (blood test)	One month after HSG
Secondary	Number of cycles of artificial reproductive techniques	Number of cycles of IUI and IVF/ICSI	6 and 12 months
Secondary	Number of cycles of artificial reproductive techniques	Number of cycles of IUI and IVF/ICSI	6 months
Secondary	Number of cycles of artificial reproductive techniques	Number of cycles of IUI and IVF/ICSI	12 months
Secondary	Neonatal thyroid dysfunction	Screening on congenital thyroid dysfunction postpartum	Within one week after birth