Cost-effectiveness of transvaginal hydrolaparoscopy in the work-up for subfertility.|
|- candidate number||12858|
|- NTR Number||NTR3462|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||3-jun-2012|
|- Secondary IDs|| |
|- Public Title||Cost-effectiveness of transvaginal hydrolaparoscopy in the work-up for subfertility.|
|- Scientific Title||THL study: A multicenter trial comparing the cost-effectiveness of transvaginal hydrolaparoscopy and hysterosalpingography in the work-up for subfertility.|
|- hypothesis||To diagnose tubal pathology various diagnostic tests are available. The current first line diagnostic test for tubal patency testing is hysterosalpingography (HSG). Transvaginal hydrolaparoscopy (THL) has recently been developed as a new outpatient procedure or exploration of the tubo-ovarian structures and tubal patency. In contrary to HSG, THL provides more more diagnostic information by allowing direct visualization of the tuboovarian structures. THL can directly identify women with tubal pathology with an accuracy approximating that of diagnostic laparoscopy, resulting in more women that will receive the proper treatment.
Based upon these considerations, we hypothesize that in a strategy using THL, women will have a shorter time to live birth compared to a strategy starting with HSG.|
|- Healt Condition(s) or Problem(s) studied||Subfertility, Tubal patency testing|
|- 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||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.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-aug-2012|
|- planned closingdate||1-aug-2016|
|- Target number of participants||1330|
|- 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 occlusion, two-sided tubal occlusion, or adhesions, when the initial test fails, or fails to show a reliable result, a DLS will be scheduled. Subsequently in women with a normal HSG, a DLS will be planned if pregnancy does not occur after 6 to 12 months.
After tubal assessment, women will be treated according to the national guidelines for subfertility. This treatment may consist of expectant management in case of a good prognosis to conceive naturally, intra uterine inseminations or in vitro fertilisation, according to the guideline of the Dutch Society for Obstetrics and Gynaecology (NVOG).
|- Primary outcome||The primary outcome will be a live born child. If no pregnancy occurs, follow-up ends after 24 months.|
|- Secondary outcome||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).
|- Trial web site||http://www.studies-obsgyn.nl|
|- CONTACT FOR PUBLIC QUERIES||Dr. C.A.M. Koks|
|- CONTACT for SCIENTIFIC QUERIES||Dr. C.A.M. Koks|
|- Sponsor/Initiator |
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Rationale: |
Infertility or involuntary childlessness is one of life's great misfortunes that affects approximately one in ten couples that aim for conception. Together with poor semen quality and anovulation, tubal pathology ranks among the most frequent causes of subfertility. From the 15,000 couples presenting with subfertility each year, approximately 3,000 will have tubal pathology.
To diagnose tubal pathology various diagnostic tests are available. Hysterosalpingography (HSG) and diagnostic laparoscopy are established invasive tests. Recently, transvaginal hydrolaparoscopy (THL) was developed. THL has the advantage of direct visualisation of the tubes, but in contrast to diagnostic laparoscopy, the procedure can be performed in an outpatient setting.
Although THL seems promising, it is unclear what its effectiveness and costs are relative to the current best imaging strategy, HSG.
The purpose of this study is to assess the costs and effects of THL compared to HSG in a large randomized controlled trial.
Multicenter randomized controlled clinical trial.
Subfertile women scheduled for tubal patency testing.
Women will be randomly allocated to THL or HSG.
Main study parameters/endpoints:
The primary outcome is cumulative live birth rate at 24 months. 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.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
As we compare strategies that are already applied in current practice, no additional risks or burdens are expected from the study.
|- Main changes (audit trail)|
|- RECORD||3-jun-2012 - 17-jun-2012|
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