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Cost-effectiveness of IUI, IVF and ICSI for male subfertility. The MAle Subfertility Therapy Effectiveness Rcts.

Cost-effectiveness of IUI, IVF and ICSI for male subfertility. The MAle Subfertility Therapy Effectiveness Rcts.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21655
Enrollment
364
Registered
2013-01-14
Start date
2013-06-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IVF, IUI, male subfertility (mannelijke subfertiliteit), cost-effectiveness (kosteneffectiviteit)

Interventions

3 cycles of IVF, including transfer of cryopreserved embryos vs 3 cycles of IUI, followed by 3 cycles of IUI-COH.

Sponsors

Academic Medical Center (AMC)
Lead Sponsor

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 3-6.10^6.

Exclusion criteria

Exclusion criteria: 1. Severe male subfertility: Pre-wash TMSC < 3.10^6; 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

MeasureTime frame
The primary outcome is establishment of ongoing pregnancy leading to live birth within the treatment time horizon.

Secondary

MeasureTime 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

j.d.bruin@jbz.nl+31 (0)73 6998660

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)