To evaluate whether in an IVF program routine application of an ORT and a subsequent individualised FSH regimen is cost-effective compared to a standard dose regimen.
ID
Source
Brief title
Condition
- Reproductive tract disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome will be live birth and costs based on previous calculations
of the various study procedures
Secondary outcome
Secondary outcomes will be poor ovarian response, hyperresponse, cycle
cancellation rates, number of cycles needed per live birth.
Background summary
IVF is a very costly treatment due to the use of gonadotropins (FSH). In
current clinical practice FSH is usually given in a standard dose. However, due
to differences in ovarian reserve between women, the ovarian response also
differs with negative consequences on pregnancy rates. In the last decade
ovarian reserve tests (ORT) have frequently been performed prior to IVF,
without consensus on the translation to FSH dose and without a systematic
evaluation of its costs and effects. We hypothesize that in women undergoing
IVF an individualized dose regimen for FSH based on an ORT is more
cost-effective, but this has never been assessed.
Study objective
To evaluate whether in an IVF program routine application of an ORT and a
subsequent individualised FSH regimen is cost-effective compared to a standard
dose regimen.
Study design
Cohort study in which all women scheduled for IVF undergo ORT. Women with a
predicted poor or high ovarian response will be randomised between the
individualised FSH regimen and the standard dose regimen.
Intervention
All women will undergo assessment of their ovarian reserve using the Antral
Follicle Count (AFC) for prediction of poor response or high response. Women
with a predicted poor response will be randomised for an increased FSH dosage
or standard dosage (150 IU/d), whereas women with a predicted hyperresponse
will be randomised for a decreased FSH dosage or standard dosage (150 IU/d).
Study burden and risks
Burden and risks do not differ from routinely applied IVF treatment
Heidelberglaan 100
3584 CX
NL
Heidelberglaan 100
3584 CX
NL
Listed location countries
Age
Inclusion criteria
- Regular indication for IVF or IVF-ICSI
- Female age < 44 years
- Regular cycle (average length 25-35 days)
- No major uterine or ovarian abnormalities detected at TVS
- No previous IVF cycles or first IVF cycle after birth of a child
- Written informed consent
Exclusion criteria
- Oocyte donation
- Medical contra indication for pregnancy or IVF treatment
- Polycystic Ovary Syndrome (PCOS)
- Untreated endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney)
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2010-023879-25-NL |
| CCMO | NL32902.041.11 |
| Other | NTR TC = 2657 |