Intrauterine Abnormalities in InfertilityPhase 4inSIGHTNCT01242852
SIGnificance of Routine Hysteroscopy Prior to a First 'in Vitro Fertilization'(IVF) Treatment Cycle
A Phase 4 study testing Office hysteroscopy (in combination with a 'Saline Infusion Sonography'(SIS)) in people with Intrauterine Abnormalities in Infertility, run by UMC Utrecht at 1 site in Netherlands.
Trial 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%. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intrauterine Abnormalities in Infertility
- What is being tested?
- Office hysteroscopy (in combination with a 'Saline Infusion Sonography'(SIS))
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2011to Mar 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Women indicated for a first IVF/ICSI treatment
- Primary or secondary infertility
- Normal Transvaginal Ultrasound, performed in the follicular phase of the menstrual cycle
Who cannot join
- Recurrent miscarriage
- Prior hysteroscopy treatments
- Meno-metrorrhagia (defined as any intermenstrual loss of blood)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Medical Center Utrecht
Utrecht, Utrecht, 3584 CX
About this study
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.
Read more
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
- Being tested
- Office hysteroscopy (in combination with a 'Saline Infusion Sonography'(SIS))
- Keywords
- Hysteroscopy, infertility, subfertility, intrauterine abnormalities, intracavitary pathology, IVF, ICSI, in vitro fertilization, intracytoplasmic sperm injection
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Office hysteroscopy (in combination with a 'Saline Infusion Sonography'(SIS))Procedure or surgery
Also called Hysteroscopy
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 18 months
Secondary outcomes (6)
Implantation rate
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)
Measured: 18 months
Miscarry rate
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)
Measured: 18 months
Costs
Cost calculations of, SIS, hysteroscopy procedures and the IVF treatment
Measured: 24 months
Patient tolerance
Patient tolerance of a SIS and diagnostic/therapeutic hysteroscopy procedure
Measured: 24 months
Prevalence of unexpected intrauterine abnormalities
Measured: 3 months
Diagnostic accuracy of SIS
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2010 (estimated)
- Study startMay 2011
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intrauterine Abnormalities in InfertilityStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Erasmus Medical Center, Maastricht University Medical Center, Maxima Medical Center
- Responsible party
- Principal investigator, Bart CJM Fauser, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01242852
- Sponsor's protocol ID
- inSIGHT
- Acronym
- inSIGHT
- Status last verified
- Jun 2015
- First submitted
- 16 Nov 2010
- Last updated
- 4 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27132052Smit 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.
PubMed 22873367
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SIGnificance of Routine Hysteroscopy Prior to a First 'in Vitro Fertilization'(IVF) Treatment Cycle
- ClinicalTrials.gov ID
- NCT01242852
- Acronym / sponsor ID
- inSIGHT / inSIGHT
- Keywords
- Hysteroscopy, infertility, subfertility, intrauterine abnormalities, intracavitary pathology, IVF, ICSI, in vitro fertilization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Erasmus Medical Center, Maastricht University Medical Center, Maxima Medical Center
- Study start
- May 2011
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 17 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Additional diagnostic tests | Experimental | Procedure: Office hysteroscopy (in combination with a 'Saline Infusion Sonography'(SIS))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. |
| Routine fertility workup | No intervention | –Patients allocated to the conventional strategy will be scheduled for IVF and undergo standard treatment, without SIS or hysteroscopy. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Women indicated for a first IVF/ICSI treatment
- Primary or secondary infertility
- Normal Transvaginal Ultrasound, performed in the follicular phase of the menstrual cycle
Key exclusion criteria (3 listed)
- Recurrent miscarriage
- Prior hysteroscopy treatments
- Meno-metrorrhagia (defined as any intermenstrual loss of blood)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Office hysteroscopy (in combination with a 'Saline Infusion Sonography'(SIS))Also: HysteroscopyRoutine 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. | Procedure or surgery | Additional diagnostic tests |
Primary outcome
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)
6 secondary outcomes
Implantation rate
Time frame: 18 months
Miscarry rate
Time frame: 18 months
Costs
Time frame: 24 months
Patient tolerance
Time frame: 24 months
Prevalence of unexpected intrauterine abnormalities
Time frame: 3 months
Diagnostic accuracy of SIS
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2015.
- Derived from this study: PubMed 27132052Smit 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.
- Derived from this study: PubMed 22873367Smit 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.
- All consortium studies performed multicentered in The NetherlandsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Office hysteroscopy (in combination with a 'Saline Infusion Sonography'(SIS)) in people with Intrauterine Abnormalities in Infertility, run by UMC Utrecht at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ongoing pregnancy (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01242852, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2015.