Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: SIGnificance of Routine Hysteroscopy Prior to a First 'in Vitro Fertilization'(IVF) Treatment Cycle
Brief Summary: BACKGROUND: Despite the numerous advances in the field of in vitro fertilisation/intracytoplasmic sperm injection (IVF/ICSI), there still exists a maximum implantation rate per embryo transferred of about 30%. Next to the physiological and physic burden that comes with every IVF treatment cycle, implantation failure also adds up to the considerable costs associated with ART. Studies have shown, that minor intrauterine abnormalities can be found in 11-40% of the infertile women with a normal transvaginal sonography. Detection and treatment of these abnormalities by office hysteroscopy have led to a 9-13% increase in pregnancy rate. Therefore, it is increasingly advocated to screen all infertile women on intracavitary pathology prior to the start of IVF/ICSI.

OBJECTIVE: The aim of the proposed study is to assess whether diagnosing and treating unsuspected intrauterine abnormalities by saline infusion sonography and/or routine office hysteroscopy prior to a first IVF/ICSI treatment cycle improves the cost-effectiveness of the fertility treatment.

STUDY DESIGN: Multicenter randomized intervention study. POPULATION: Asymptomatic women, indicated for a first IVF/ICSI treatment cycle and a normal transvaginal ultrasonography.

INTERVENTION: Participants will be randomized for a (SIS and) hysteroscopy with treatment-on-the spot of predefined intrauterine abnormalities versus no diagnostic work-up. In both groups standard IVF/ICSI treatment will be initiated.

PRIMARY OUTCOME MEASURE:

Cumulative ongoing pregnancy rate resulting in live birth achieved within 18 months of IVF/ICSI treatment after randomization (obtained in both treatment cycles with fresh embryos, as well as in subsequent cryo/thaw cycles)

SECONDARY OUTCOME MEASURE:

* Cumulative implantation rate achieved within 18 months of IVF/ICSI treatment after randomization (obtained in both treatment cycles with fresh embryos, as well as in subsequent cryo/thaw cycles)
* Cumulative miscarry rate within 18 months of IVF/ICSI treatment after randomization (obtained in both treatment cycles with fresh embryos, as well as in subsequent cryo/thaw cycles)
* Cost calculations of, SIS, hysteroscopy procedures and the IVF treatment
* Patient preference and tolerance of a SIS and diagnostic/therapeutic hysteroscopy procedure
* Prevalence of unexpected intrauterine abnormalities
* Diagnostic accuracy of SIS in diagnosing intrauterine abnormalities


Options:
A: Arm Label: Uterine polypectomy using morcellator; Type: EXPERIMENTAL; Interventions: Device: hysteroscopic morcellator (TruClear) | Arm Label: Electical Resection; Type: ACTIVE_COMPARATOR; Interventions: Device: Bipolar Electrical resectoscope (Versapoint) | Intervention Type: DEVICE; Name: hysteroscopic morcellator (TruClear); Assigned to Arm(s): Uterine polypectomy using morcellator | Intervention Type: DEVICE; Name: Bipolar Electrical resectoscope (Versapoint); Assigned to Arm(s): Electical Resection
B: Arm Label: Office hysteroscopy and endometrial snip; Type: EXPERIMENTAL; Interventions: Procedure: Office hysteroscopy and endometrial snip | Arm Label: Office hyteroscopy; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Office hysteroscopy | Intervention Type: PROCEDURE; Name: Office hysteroscopy and endometrial snip; Assigned to Arm(s): Office hysteroscopy and endometrial snip | Intervention Type: PROCEDURE; Name: Office hysteroscopy; Assigned to Arm(s): Office hyteroscopy
C: Intervention Type: PROCEDURE; Name: vaginoscopic hysteroscopy; Assigned to Arm(s): N/A
D: Arm Label: Additional diagnostic tests; Type: EXPERIMENTAL; Interventions: Procedure: Office hysteroscopy (in combination with a 'Saline Infusion Sonography'(SIS)) | Arm Label: Routine fertility workup; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: PROCEDURE; Name: Office hysteroscopy (in combination with a 'Saline Infusion Sonography'(SIS)); Assigned to Arm(s): Additional diagnostic tests

Answer: D