THL study: A multicenter trial comparing the cost-effectiveness of transvaginal hydrolaparoscopy and hysterosalpingography in the work-up for subfertility.

THL study: A multicenter trial comparing the cost-effectiveness of transvaginal hydrolaparoscopy and hysterosalpingography in the work-up for subfertility. - THL-study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39517

Enrollment

1330

Registered

2012-11-28

Start date

2013-06-15

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

fallopian tube patency test tubal patency test

Interventions

Intervention: Women will be randomly allocated to THL or HSG.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Women presenting with primary or secondary subfertility for at least 12 months * Age >18 years * Normal transvaginal ultrasound, performed in the follicular phase of the menstrual cycle * Presence of both ovaries

Exclusion criteria

Exclusion criteria: * Positive Chlamydia status at PCR * Prior tubal testing * Immobile uterus not allowing THL * Women with a uterus in retroversion flexion, as a THL is not feasible in these women * Masses/or cysts in the pouch of Douglas or ovarian cysts, interfering with THL * Prior tubal surgery * Iodine allergy

Design outcomes

Primary

Measure	Time frame
Main study parameters/endpoints: The primary outcome is cumulative live birth rate at 24 months.	—

Secondary

Measure	Time frame
Secondary outcomes are time to live birth, pregnancy outcome (on-going pregnancy, miscarriage, multiple pregnancy), complications, diagnostic accuracy, generic quality of life, pain and discomfort, patient preferences and costs.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)