Cost-effectiveness of transvaginal hydrolaparoscopy 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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22115

Enrollment

1330

Registered

2012-06-03

Start date

2012-08-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

tubal patency, subfertility

Interventions

Women who are randomized in the THL arm will undergo a THL for fallopian tube assessment. In the HSG-arm all women will undergo a HSG. When abnormalities are seen at HSG, like one-sided tubal occlus

Eligibility

Inclusion criteria

Inclusion criteria: 1. Women presenting with primary or secondary subfertility for at least 12 months; 2. Age 18-39 years; 3. Normal transvaginal ultrasound, performed in the follicular phase of the menstrual cycle; 4. Presence of both ovaries.

Exclusion criteria

Exclusion criteria: 1. Positive Chlamydia status at PCR; 2. Prior tubal testing; 3. Immobile uterus not allowing THL; 4. Women with a uterus in retroversion flexion, as a THL is not feasible in these women; 5. Masses/or cysts in the pouch of Douglas or ovarian cysts, interfering with THL; 6. Prior tubal surgery; 7. Iodine allergy.

Design outcomes

Primary

Measure	Time frame
The primary outcome will be a live born child. If no pregnancy occurs, follow-up ends after 24 months.	—

Secondary

Measure	Time frame
1. Time-to live-birth; 2. Clinical pregnancy, defined as any registered heart beat at ultrasonography; 3. On-going pregnancy, viable intra-uterine singleton pregnancy, defined as fetal heart beat seen by ultrasonography at 12 weeks gestation; 4. Miscarriage, defined as loss of an intra-uterine pregnancy (confirmed by ultrasound or histologic examination) before the 16th week of pregnancy; 5. Multiple pregnancy, defined as a registered heartbeat of at least two foetuses at 12 weeks of gestation; 6. Ectopic pregnancy; 7. Complications (bowel perforation, bladder perforation, bleeding, anaphylactic shock); 8. Costs (direct and indirect); 9. Pain scores and acceptability scores on a visual analogue scale (VAS) from zero (no pain, perfectly acceptable) to ten (unbearable pain, completely unacceptable); 10. Generic quality of life QOL (SF-36).	—

Measure

Time frame

1. Time-to live-birth; 2. Clinical pregnancy, defined as any registered heart beat at ultrasonography; 3. On-going pregnancy, viable intra-uterine singleton pregnancy, defined as fetal heart beat seen by ultrasonography at 12 weeks gestation; 4. Miscarriage, defined as loss of an intra-uterine pregnancy (confirmed by ultrasound or histologic examination) before the 16th week of pregnancy; 5. Multiple pregnancy, defined as a registered heartbeat of at least two foetuses at 12 weeks of gestation; 6. Ectopic pregnancy; 7. Complications (bowel perforation, bladder perforation, bleeding, anaphylactic shock); 8. Costs (direct and indirect); 9. Pain scores and acceptability scores on a visual analogue scale (VAS) from zero (no pain, perfectly acceptable) to ten (unbearable pain, completely unacceptable); 10. Generic quality of life QOL (SF-36).

—

Contacts

Public ContactC.A.M. Koks

MMC, department of Obstetrics and Gynecology Postbus 7777

c.koks@mmc.nl+31 (0)40 8888384

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)