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-…
ID
Source
Brief title
Condition
- Pregnancy, labour, delivery and postpartum conditions
- Uterine, pelvic and broad ligament disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- 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
- 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
Background summary
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. Studie have shown, that minor intrauterine
abnormalities can be found in 11-40% of the infertile women with a normal
tranvaginal sonography. Detection and treatment of these abnormalities by
office hysteroscopy have led to a 9-13% increase in pregnancy rate. Therefore,
it is increasingly advocateed to screen all infertile women on intracavitary
pathology prior to the start of IVF/ICSI.
Study 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.
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.
Study burden and risks
The burden en risks of participation are related to the burden of extra
investigations and the risks to the risks of the diagnostic tests itself. Due
to entering the uterine cavity during SIS and hysteroscopy the risks exist of
infection, perforation (<0.1%). Also adhesions may develop after resection of
one of the predefined intra-uterine abnormalities.
The benefit is an increase in chance to conceive, unknown to which extent in
patients who undergo their first IVF/ICSI treatment.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL32646.041.10 |