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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Erasmus Medical Center
Maastricht University Medical Center
Maxima Medical Center
Information provided by (Responsible Party):
Frank JM Broekmans, UMC Utrecht
ClinicalTrials.gov Identifier:
NCT01242852
First received: November 16, 2010
Last updated: November 25, 2013
Last verified: November 2013
  Purpose

BACKGROUND: Despite the numerous advances in the field of 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

Condition Intervention Phase
Intrauterine Abnormalities in Infertility
Procedure: Office hysteroscopy (in combination with a 'Saline Infusion Sonography'(SIS))
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Diagnostic
Official Title: SIGnificance of Routine Hysteroscopy Prior to a First 'in Vitro Fertilization'(IVF) Treatment Cycle

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • Ongoing pregnancy [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • Implantation rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Cumulative implantation rate 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)

  • Miscarry rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Cumulative miscarry rate 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)

  • Costs [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Cost calculations of, SIS, hysteroscopy procedures and the IVF treatment

  • Patient tolerance [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Patient tolerance of a SIS and diagnostic/therapeutic hysteroscopy procedure

  • Prevalence of unexpected intrauterine abnormalities [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Diagnostic accuracy of SIS [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 738
Study Start Date: May 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Additional diagnostic tests
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 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, polypsnare 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.
Other Name: Hysteroscopy
No Intervention: Routine fertility workup
Patients allocated to the conventional strategy will be scheduled for IVF and undergo standard treatment, without SIS or hysteroscopy.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01242852

Locations
Netherlands
University Medical Center Utrecht
Utrecht, Netherlands, 3584 CX
Sponsors and Collaborators
UMC Utrecht
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Erasmus Medical Center
Maastricht University Medical Center
Maxima Medical Center
  More Information

Additional Information:
No publications provided by UMC Utrecht

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Frank JM Broekmans, MD, PhD, UMC Utrecht
ClinicalTrials.gov Identifier: NCT01242852     History of Changes
Other Study ID Numbers: inSIGHT
Study First Received: November 16, 2010
Last Updated: November 25, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by UMC Utrecht:
Hysteroscopy
infertility
subfertility
intrauterine abnormalities
intracavitary pathology
IVF
ICSI
in vitro fertilization
intracystoplasmic sperm injection

Additional relevant MeSH terms:
Congenital Abnormalities
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on August 28, 2014