Is Hysterosalpingo-Foam Sonografie (HyFoSy) een kosteneffectief alternatief voor hysterosalpingografie (HSG) als tubadoorgankelijkheidstest in subfertiele vrouwen?

Is Hysterosalpingo-Foam Sonography (HyFoSy) a cost-effective alternative for hysterosalpingography (HSG) in assessing tubal patency in subfertile women?

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28335

Enrollment

1163

Registered

2014-08-19

Start date

2015-05-07

Completion date

Unknown

Last updated

2024-06-11

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

Conditions

None listed

Interventions

RCT1: Hysterosalpingo-foam sonography (HyFoSy) and hysterosalpingography (HSG) in a random order. In case of discordance test results between HyFoSy and HSG women will be included in RCT 2: management

Eligibility

Inclusion criteria

Inclusion criteria: - Between 18-41 years - Subfertile for at least one year. - Valid indication for patency testing in the fertility work-up or before intra-uterine insemination treatment.

Exclusion criteria

Exclusion criteria: - Anovulation not responding on ovulation induction - Endometriosis - Tubal patency testing in the past - Severe male factor with a Total motile sperm count <1x106/ml - Known contrast (iodine) allergy - If not willing or able to sign the informed consent

Design outcomes

Primary

Measure	Time frame
The primary outcome is ongoing pregnancy rates leading to live birth within 12-months after inclusion.	—

Secondary

Measure	Time frame
The secondary outcomes are: - Time to pregnancy - Clinical pregnancy rate - Miscarriage rate - Multiple pregnancy rate - Preterm birth rate - Concordance between HyFoSy and HSG - Direct and indirect costs - Pain scores	—

Contacts

Public ContactJ. van Rijswijk

VUmc - Voortplantingsgeneeskunde, De Boelelaan 1118, PK -1Y 154, 1081 HZ Amsterdam

j.vanrijswijk@vumc.nl020-4445277

Outcome results