NCT01242852

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
750

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2011

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 17, 2010

Completed
6 months until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

June 4, 2015

Status Verified

June 1, 2015

Enrollment Period

3.8 years

First QC Date

November 16, 2010

Last Update Submit

June 3, 2015

Conditions

Intrauterine Abnormalities in Infertility

Keywords

Hysteroscopyinfertilitysubfertilityintrauterine abnormalitiesintracavitary pathologyIVFICSIin vitro fertilizationintracytoplasmic sperm injection

Outcome Measures

Primary Outcomes (1)

  • Ongoing pregnancy

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

    18 months

Secondary Outcomes (6)

  • Implantation rate

    18 months

  • Miscarry rate

    18 months

  • Costs

    24 months

  • Patient tolerance

    24 months

  • Prevalence of unexpected intrauterine abnormalities

    3 months

  • +1 more secondary outcomes

Study Arms (2)

Additional diagnostic tests

EXPERIMENTAL

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.

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

Routine fertility workup

NO INTERVENTION

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

Interventions

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

Routine fertility work-up, added up with diagnostic tests. In 5 research centers the extra tests consist of SIS \& hysteroscopy (HY). In the other research hospitals it consists of only a HY. The HY examination will be scheduled on Day 3-12 of a cycle. It will be performed in an outpatient setting with a vaginoscopic approach. A 5-mm diameter continuous flow hysteroscope and a 30º direction of view will be used. The uterus will be inspected methodically a endometrial biopsy obtained and the findings recorded into a standardized form. Intrauterine pathology is defined as septum, endometrial polyp, submucous myoma, adhesions \& endometritis. These will be treated, using scissors, Versapoint, grasping forceps, polyp snare or antibiotics. In 5 of the research hospitals, 1 week prior to the HY, also a SIS will be performed. Via a catheter saline solution will be infused into the uterine cavity as distention media. The findings at the following sonography will be standardized recorded.

Also known as: Hysteroscopy
Additional diagnostic tests

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Utrecht

Utrecht, Utrecht, 3584 CX, Netherlands

Location

Related Publications (2)

  • 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.

    PMID: 27132052DERIVED

  • 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.

    PMID: 22873367DERIVED

Related Links

MeSH Terms

Conditions

Infertility

Interventions

Hysteroscopy

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and GynecologicalDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeObstetric Surgical ProceduresGynecologic Surgical ProceduresUrogenital Surgical Procedures

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

November 16, 2010

First Posted

November 17, 2010

Study Start

May 1, 2011

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

June 4, 2015

Record last verified: 2015-06

Locations

NL(1)