Intrauterine abnormalities
Conditions
Interventions
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 treatm
Sponsors
Divisie Vrouw en Baby
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Women indicated for a first IV/'intracytoplasmic sperm injection' (ICSI) treatment Primary or secondary infertility Normal Transvaginal Ultrasound, performed in the follicular phase of the menstrual cycle
Exclusion criteria
Exclusion criteria: Recurrent miscarriage (defined as two or more miscarriages prior to the 20th week of gestation) Prior hysteroscopy treatments Meno-metrorrhagia (defined as any intermenstrual loss of blood)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - 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
| Measure | Time frame |
|---|---|
| - 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) - 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) - Cost calculations of, SIS, hysteroscopy procedures and the IVF treatment - Patient preference tolerance of a SIS and diagnostic/therapeutic hysteroscopy procedure - Prevalence of unexpected intrauterine abnormalities - Diagnostic accuracy of SIS in diagnosing intrauterine abnormalities | — |
Countries
Netherlands
Outcome results
None listed