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Completed

NCT Number: NCT01242852

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

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

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Key information

Conditions

Intrauterine Abnormalities in Infertility Genital Diseases Infertility Urogenital Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University Medical Center Utrecht

Utrecht, 3584 CX, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Other names: Hysteroscopy

Primary outcomes

  1. Ongoing pregnancy

    Time frame: 18 months

    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 outcomes

  1. Implantation rate

    Time frame: 18 months

    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)

  2. Miscarry rate

    Time frame: 18 months

    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)

  3. Costs

    Time frame: 24 months

    Cost calculations of, SIS, hysteroscopy procedures and the IVF treatment

  4. Patient tolerance

    Time frame: 24 months

    Patient tolerance of a SIS and diagnostic/therapeutic hysteroscopy procedure

  5. Prevalence of unexpected intrauterine abnormalities

    Time frame: 3 months

  6. Diagnostic accuracy of SIS

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • Erasmus Medical Center
  • Maastricht University Medical Center
  • Maxima Medical Center

Registry information

Acronym: inSIGHT

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Nov 17, 2010
Registry last updated
Jun 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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