ICSI, IVF, male subfertility (mannelijke subfertiliteit), cost-effectiveness (kosteneffectiviteit)
Conditions
Interventions
3 cycles of ICSI, including transfer of cryopreserved embryos vs 3 cycles of IVF, including transfer of cryopreserved embryos.
Sponsors
Academic Medical Center (AMC)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age female partner: 18-38 years; 2. Failure to conceive: 12-36 months; 3. Male subfertility: Pre-wash TMSC 300.000.
Exclusion criteria
Exclusion criteria: 1. Severe male subfertility: Pre-wash TMSC < 300.000; 2. Female partner with polycystic ovary syndrome or any other anovulation, severe endome-triosis, double-sided tubal pathology, endocrinopathological disease (Cushing syndrome, adrenal hyperplasia, hyperprolactinemia, acromegaly, imminent ovarian failure, premature ovarian failure, hypothalamic amenorrhea and diabetes mellitus (type I).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is establishment of ongoing pregnancy leading to live birth within the treatment time horizon. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to pregnancy, miscarriage, multiple pregnancy and live birth rate are secondary outcomes. Further secondary outcomes are neonatal mortality, pregnancy complications (preterm birth < 37 weeks, birth weight < 2.500 gram, PIH, (pre-) eclampsia, HELLP) costs of reproductive treatments, perinatal care and ad-verse events. Also patients' quality of life and preferences will serve as secondary outcomes. | — |
Contacts
Public ContactJ.P. Bruin, de
Postbus 90153
Outcome results
None listed