Tubal flushing with oil-based contrast during HSG in subfertile women: Is early flushing effective and cost-effective as compared to delayed flushing?

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON52895

Enrollment

354

Registered

2019-07-23

Start date

2019-08-22

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

testing whether the fallopian tubes are open Tubal patency testing

Interventions

Direct tubal flushing with oil-based contrast as part of the fertility work-up compared to delayed tubal flushing 6 months after the fertility work-up is completed.

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Women between 18-39 years of age - Spontaneous menstrual cycle - Perceived low risk for tubal pathology - Undergoing fertility work-up with an indication for tubal patency testing

Exclusion criteria

Exclusion criteria: - Women with known endocrine disorders (e.g. the polycystic ovary syndrome, diabetes, hyperthyroidism and hyperprolactinemia, except for well managed hypothyroidism (TSH 0.3-2.5mIU/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

Design outcomes

Primary

Measure	Time frame
Primary outcome is time to life birth within 6 and 12 months after randomization. Time to live birth within 6 months after randomization provides us information about the comparison on HSG with oil-based contrast performed during fertility work-up compared to no HSG. Time to live birth within 12 months after randomization provides information on the comparison of HSG with oil-based contract during fertility work-up versus 6 months after completing fertility work-up. 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.	—

Measure

Time frame

Primary outcome is time to life birth within 6 and 12 months after randomization. Time to live birth within 6 months after randomization provides us information about the comparison on HSG with oil-based contrast performed during fertility work-up compared to no HSG. Time to live birth within 12 months after randomization provides information on the comparison of HSG with oil-based contract during fertility work-up versus 6 months after completing fertility work-up. 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.

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Secondary

Measure	Time frame
- Life birth - Clinical pregnancy - Ongoing pregnancy - Miscarriage - Ectopic pregnancy - Multiple pregnancy - Complications following HSG (infection, intravastion) - Pregnancy outcomes (f.e. birth weight) - Pregnancy complications - Stillbirth - Thyroid function of the woman (before and 1 month after HSG) - Neonatal outcomes - Additional fertility treatments (Intra-uterine insemination, IVF, IVF/ICSI) - Direct and indirect costs within 12 months after randomization - Thyroid function of neonate (determined by heelprick by RIVM) - Level of pain and anxiety during HSG	—

Measure

Time frame

- Life birth - Clinical pregnancy - Ongoing pregnancy - Miscarriage - Ectopic pregnancy - Multiple pregnancy - Complications following HSG (infection, intravastion) - Pregnancy outcomes (f.e. birth weight) - Pregnancy complications - Stillbirth - Thyroid function of the woman (before and 1 month after HSG) - Neonatal outcomes - Additional fertility treatments (Intra-uterine insemination, IVF, IVF/ICSI) - Direct and indirect costs within 12 months after randomization - Thyroid function of neonate (determined by heelprick by RIVM) - Level of pain and anxiety during HSG

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)