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Oil- based versus water-based contrast media for hysterosalpingography (HSG) in infertile women with unevaluated indications: a randomized controlled trial

Oil- based versus water-based contrast media for hysterosalpingography (HSG) in infertile women with unevaluated indications: a randomized controlled trial - H2Oil2 study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON52387
Enrollment
680
Registered
2019-07-22
Start date
2019-08-20
Completion date
Unknown
Last updated
2025-03-24

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

Conditions

testing if the fallopian tubes are open Tubal patency testing

Interventions

We will compare tubal flushing with oil-based contrast (intervention) versus tubal flushing with water-based contrast (control).

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Women: 1: with ovulation disorders (defined as less than 8 menstrual cycles per year) or; 2: at high risk for tubal pathology (defined as a positive chlamydia infection, a pelvic inflammatory disease, known endometriosis, abdominal surgery (including tubectomy for ectopic pregnancy and appendectomy) and/or peritonitis in the medical history) or; 3: above 38 years of age

Exclusion criteria

Exclusion criteria: - Iodine allergy - Male subfertility defined as a post-wash total motile sperm count

Design outcomes

Primary

MeasureTime frame
Primary outcome is conception leading to live birth within 6 months after randomization.

Secondary

MeasureTime frame
- Biochemical pregnancy - 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) - Costs within 6 months after randomization - Thyroid function of neonate (determined by heelprick)

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)