SIGnificance of Routine Hysteroscopy Prior to a First 'in Vitro Fertilization'(IVF) Treatment Cycle (inSIGHT)
This study is currently recruiting participants.
Verified April 2013 by UMC Utrecht
Sponsor:
UMC Utrecht
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: April 24, 2013
Last verified: April 2013
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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: | May 2015 |
| Estimated Primary Completion Date: | May 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01242852
Contacts
| Contact: F.J.M Broekmans, M.D., PhD | 0031887551041 | f.broekmans@umcutrecht.nl |
| Contact: J.G. Smit, M.D. | 0031887553629 | jsmit6@umcutrecht.nl |
Locations
| Netherlands | |
| University Medical Center Utrecht | Recruiting |
| Utrecht, Netherlands, 3584 CX | |
| Contact: F.J.M Broekmans, M.D., PhD 0031887551041 f.broekmans@umcutrecht.nl | |
| Contact: J.G. Smit, M.D. 0031887553629 jsmit6@umcutrecht.nl | |
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: | April 24, 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 May 19, 2013