SIGnificance of Routine Hysteroscopy Prior to a First 'in Vitro Fertilization'(IVF) Treatment Cycle (inSIGHT)

UMC Utrecht

Status and phase: Completed; Phase 4

Conditions: Intrauterine Abnormalities in Infertility

Treatments: Procedure: Office hysteroscopy (in combination with a 'Saline Infusion Sonography'(SIS))

Study type: Interventional

Funder types: Other

Identifiers

NCT01242852

inSIGHT

Details and patient eligibility

About

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

Enrollment: 750 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women indicated for a first IVF/ICSI treatment
• Primary or secondary infertility
• Normal Transvaginal Ultrasound, performed in the follicular phase of the menstrual cycle

Exclusion criteria

• Recurrent miscarriage
• Prior hysteroscopy treatments
• Meno-metrorrhagia (defined as any intermenstrual loss of blood)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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750 participants in 2 patient groups

Additional diagnostic tests

Experimental group

Description:

Participants in the experimental arm will undergo standard hysteroscopy with treatment-on-the spot of predefined intrauterine abnormalities. In two of the participating clinics, also a 'Saline Infusion Sonography' (SIS) will be performed, 1 week before the hysteroscopy. After the additional diagnostic test(s), standard IVF/ICSI treatment will be initiated.

Treatment:

Procedure: Office hysteroscopy (in combination with a 'Saline Infusion Sonography'(SIS))

Routine fertility workup

No Intervention group

Description:

Patients allocated to the conventional strategy will be scheduled for IVF and undergo standard treatment, without SIS or hysteroscopy.