decreased male fertility Male subfertility
Conditions
Interventions
RCT 1: 3 cycles of IUI, followed by 3 cycles of IUI-COH. Control: expectant
management. Treatment time horizon 6 months.
RCT 2: 3 cycles of ICSI, including transfer of cryoembryos. Control: 3 cycles
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: RCT 1: - Male subfertility: Pre-wash TMSC 3.10^6 - Age female partner 18-42 years - Failure to conceive for at least 12 - Couple who start treatment for a first, or first after a successful pregnancy, cycle RCT 2 - Age female partner between: 18-42 years - Male subfertility: Pre-wash TMSC
Exclusion criteria
Exclusion criteria: RCT 1: - Female partner with polycystic ovary syndrome or any other anovulation, severe endometriosis, 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) - Major uterine or ovarian abnormalities detected by TVS which is classified as contraindication for pregnancy or medically assisted reproduction RCT 2: - Severe male subfertility: Post-wash TMSC
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ongoing pregnancy leading to live birth | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to pregnancy, miscarriage, multiple pregnancy, live birth, pregnancy complications, perinatal outcome, (in-)direct costs, quality of life and patient preferences | — |
Countries
Netherlands
Outcome results
None listed