Clinical trial NCT01242852: SIGnificance of Routine Hysteroscopy Prior to a First 'in Vitro Fertilization'(IVF) Treatment Cycle
Official title: SIGnificance of Routine Hysteroscopy Prior to a First 'in Vitro Fertilization'(IVF) Treatment Cycle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intrauterine Abnormalities in Infertility
Keywords: Hysteroscopy
infertility
subfertility
intrauterine abnormalities
intracavitary pathology
IVF
ICSI
in vitro fertilization
intracytoplasmic sperm injection
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Erasmus Medical Center
name: Maastricht University Medical Center
name: Maxima Medical Center
First posted: 2010-11-17
Enrollment: 750
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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


Eligibility criteria: 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)

Primary outcomes:
measure: Ongoing pregnancy
timeFrame: 18 months
Secondary outcomes:
measure: Implantation rate
timeFrame: 18 months
measure: Miscarry rate
timeFrame: 18 months
measure: Costs
timeFrame: 24 months
measure: Patient tolerance
timeFrame: 24 months
measure: Prevalence of unexpected intrauterine abnormalities
timeFrame: 3 months
measure: Diagnostic accuracy of SIS
timeFrame: 3 months
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
References:
citation: Smit JG, Kasius JC, Eijkemans MJC, Koks CAM, van Golde R, Nap AW, Scheffer GJ, Manger PAP, Hoek A, Schoot BC, van Heusden AM, Kuchenbecker WKH, Perquin DAM, Fleischer K, Kaaijk EM, Sluijmer A, Friederich J, Dykgraaf RHM, van Hooff M, Louwe LA, Kwee J, de Koning CH, Janssen ICAH, Mol F, Mol BWJ, Broekmans FJM, Torrance HL. Hysteroscopy before in-vitro fertilisation (inSIGHT): a multicentre, randomised controlled trial. Lancet. 2016 Jun 25;387(10038):2622-2629. doi: 10.1016/S0140-6736(16)00231-2. Epub 2016 Apr 27.
citation: Smit JG, Kasius JC, Eijkemans MJ, Koks CA, Van Golde R, Oosterhuis JG, Nap AW, Scheffer GJ, Manger PA, Hoek A, Kaplan M, Schoot DB, van Heusden AM, Kuchenbecker WK, Perquin DA, Fleischer K, Kaaijk EM, Sluijmer A, Friederich J, Laven JS, van Hooff M, Louwe LA, Kwee J, Boomgaard JJ, de Koning CH, Janssen IC, Mol F, Mol BW, Torrance HL, Broekmans FJ. The inSIGHT study: costs and effects of routine hysteroscopy prior to a first IVF treatment cycle. A randomised controlled trial. BMC Womens Health. 2012 Aug 8;12:22. doi: 10.1186/1472-6874-12-22.