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What is the Best Moment for Performing an HSG in Women With a Unfulfilled Childwish (H2Oil-timing)

Primary Purpose

Female Infertility

Status
Recruiting
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Lipiodol UltraFluid
Sponsored by
Amsterdam UMC, location VUmc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Female Infertility focused on measuring Infertility, Fallopian tubes, Hysterosalpingography, Tubal flushing, Pregnancy, Live birth, Cost-effectiveness, Randomized controlled trial

Eligibility Criteria

18 Years - 39 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Amsterdam AMCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Direct HSG during fertility work-up

Delayed HSG 6 months after completing fertility work-up

Arm Description

Tubal flushing at HSG with Lipiodol® (oil-based contrast medium) (max. 15mL) incorporated in the fertility work-up

Tubal flushing at HSG with Lipiodol® (oil-based contrast medium) (max. 15mL) after a 6 months waiting period after completion of fertility work-up

Outcomes

Primary Outcome Measures

Time to live birth
Calculated from the last menstrual bleeding within 6 months after randomization
Time to live birth
Calculated from the last menstrual bleeding within 12 months after randomization

Secondary Outcome Measures

Number of live births
Defined as the birth of a live born baby, after 24 weeks gestation
Number of live births
Defined as the birth of a live born baby, after 24 weeks gestation
Number of ongoing pregnancies
Defined as the presence of a heart beat at 10 to 12 weeks gestation
Number of ongoing pregnancies
Defined as the presence of a heart beat at 10 to 12 weeks gestation
Number of clinical pregnancies
Defined as gestational sac detected on ultrasonography
Number of miscarriages
Presence of non-vitality on ultrasound or spontaneous loss of pregnancy
Number of miscarriages
Presence of non-vitality on ultrasound or spontaneous loss of pregnancy
Number of ectopic pregnancies
Embryo implanted outside the uterine cavity
Number of ectopic pregnancies
Embryo implanted outside the uterine cavity
Number of multiple pregnancies
Pregnancy of two or more foetuses
Number of multiple pregnancies
Pregnancy of two or more foetuses
Number of complication after HSG
e.g. intravasation or infection
Number of pregnancy complications
e.g. pre-term birth, hypertension
Number of pregnancy complications
e.g. pre-term birth, hypertension
Number of still births
Death or loss of the baby before or during
Number of still births
Death or loss of the baby before or during
Incidence of thyroid dysfunction after HSG
TSH and fT4 measurement (blood test)
Number of cycles of artificial reproductive techniques
Number of cycles of IUI and IVF/ICSI
Number of cycles of artificial reproductive techniques
Number of cycles of IUI and IVF/ICSI
Number of cycles of artificial reproductive techniques
Number of cycles of IUI and IVF/ICSI
Neonatal thyroid dysfunction
Screening on congenital thyroid dysfunction postpartum

Full Information

First Posted
July 18, 2022
Last Updated
May 5, 2023
Sponsor
Amsterdam UMC, location VUmc
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT05608590
Brief Title
What is the Best Moment for Performing an HSG in Women With a Unfulfilled Childwish
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 22, 2019 (Actual)
Primary Completion Date
December 1, 2025 (Anticipated)
Study Completion Date
January 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Amsterdam UMC, location VUmc
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female Infertility
Keywords
Infertility, Fallopian tubes, Hysterosalpingography, Tubal flushing, Pregnancy, Live birth, Cost-effectiveness, Randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
554 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Direct HSG during fertility work-up
Arm Type
Experimental
Arm Description
Tubal flushing at HSG with Lipiodol® (oil-based contrast medium) (max. 15mL) incorporated in the fertility work-up
Arm Title
Delayed HSG 6 months after completing fertility work-up
Arm Type
Active Comparator
Arm Description
Tubal flushing at HSG with Lipiodol® (oil-based contrast medium) (max. 15mL) after a 6 months waiting period after completion of fertility work-up
Intervention Type
Drug
Intervention Name(s)
Lipiodol UltraFluid
Other Intervention Name(s)
Oil-based contrast
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to live birth
Description
Calculated from the last menstrual bleeding within 6 months after randomization
Time Frame
6 months
Title
Time to live birth
Description
Calculated from the last menstrual bleeding within 12 months after randomization
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Number of live births
Description
Defined as the birth of a live born baby, after 24 weeks gestation
Time Frame
6 months
Title
Number of live births
Description
Defined as the birth of a live born baby, after 24 weeks gestation
Time Frame
12 months
Title
Number of ongoing pregnancies
Description
Defined as the presence of a heart beat at 10 to 12 weeks gestation
Time Frame
6 and 12 months
Title
Number of ongoing pregnancies
Description
Defined as the presence of a heart beat at 10 to 12 weeks gestation
Time Frame
6 months
Title
Number of clinical pregnancies
Description
Defined as gestational sac detected on ultrasonography
Time Frame
12 months
Title
Number of miscarriages
Description
Presence of non-vitality on ultrasound or spontaneous loss of pregnancy
Time Frame
6 months
Title
Number of miscarriages
Description
Presence of non-vitality on ultrasound or spontaneous loss of pregnancy
Time Frame
12 months
Title
Number of ectopic pregnancies
Description
Embryo implanted outside the uterine cavity
Time Frame
6 months
Title
Number of ectopic pregnancies
Description
Embryo implanted outside the uterine cavity
Time Frame
12 months
Title
Number of multiple pregnancies
Description
Pregnancy of two or more foetuses
Time Frame
6 months
Title
Number of multiple pregnancies
Description
Pregnancy of two or more foetuses
Time Frame
12 months
Title
Number of complication after HSG
Description
e.g. intravasation or infection
Time Frame
One month after HSG
Title
Number of pregnancy complications
Description
e.g. pre-term birth, hypertension
Time Frame
6 months
Title
Number of pregnancy complications
Description
e.g. pre-term birth, hypertension
Time Frame
12 months
Title
Number of still births
Description
Death or loss of the baby before or during
Time Frame
12 months
Title
Number of still births
Description
Death or loss of the baby before or during
Time Frame
6 months
Title
Incidence of thyroid dysfunction after HSG
Description
TSH and fT4 measurement (blood test)
Time Frame
One month after HSG
Title
Number of cycles of artificial reproductive techniques
Description
Number of cycles of IUI and IVF/ICSI
Time Frame
6 and 12 months
Title
Number of cycles of artificial reproductive techniques
Description
Number of cycles of IUI and IVF/ICSI
Time Frame
6 months
Title
Number of cycles of artificial reproductive techniques
Description
Number of cycles of IUI and IVF/ICSI
Time Frame
12 months
Title
Neonatal thyroid dysfunction
Description
Screening on congenital thyroid dysfunction postpartum
Time Frame
Within one week after birth

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
V Mijatovic
Phone
+312044444567
Email
mijatovic@amsterdamumc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Danah Kamphuis
Phone
+312044444567
Email
d.kamphuis@amsterdamumc.nl
Facility Information:
Facility Name
Amsterdam AMC
City
Amsterdam
ZIP/Postal Code
1081HV
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Velja Mijatovic
Email
mijatovic@amsterdamumc.nl
First Name & Middle Initial & Last Name & Degree
Danah Kamphuis
Email
d.kamphuis@amsterdamumc.nl

12. IPD Sharing Statement

Plan to Share IPD
No

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

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