Intrauterine Abnormalities in Infertility Clinical Trial
— inSIGHTOfficial title:
SIGnificance of Routine Hysteroscopy Prior to a First 'in Vitro Fertilization'(IVF) Treatment Cycle
| Verified date | June 2015 |
| Source | UMC Utrecht |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Netherlands: Medical Ethics Review Committee (METC) |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 750 |
| Est. completion date | March 2015 |
| Est. primary completion date | March 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | N/A and older |
| Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | University Medical Center Utrecht | Utrecht |
| Lead Sponsor | Collaborator |
|---|---|
| UMC Utrecht | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Erasmus Medical Center, Maastricht University Medical Center, Maxima Medical Center |
Netherlands,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | 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) | 18 months | No |
| Secondary | 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) | 18 months | No |
| Secondary | Costs | Cost calculations of, SIS, hysteroscopy procedures and the IVF treatment | 24 months | No |
| Secondary | Patient tolerance | Patient tolerance of a SIS and diagnostic/therapeutic hysteroscopy procedure | 24 months | No |
| Secondary | Prevalence of unexpected intrauterine abnormalities | 3 months | No | |
| Secondary | Diagnostic accuracy of SIS | 3 months | No |