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ID
Source
Brief title
Health condition
Male subfertility (mannelijke subfertiliteit), cost-effectiveness (kosteneffectiviteit), Expectant management (afwachtend beleid), IUI
Sponsors and support
Intervention
Outcome measures
Primary outcome
Ongoing pregnancy leading to live birth within the treatment time horizon.
Secondary outcome
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.
Background summary
Rationale:
We hypothesize that less invasive therapies are equally effective as more invasive therapies for male subfertility.
Objective:
In one third of subfertile couples male subfertility is diagnosed. Current treatments for male subfertility, IUI, IVF and ICSI, have, despite their widespread use, not been compared on their cost-effectiveness. The primary aim of this project is to assess the cost-effectiveness of therapies for male subfertility.
Study design:
IUI versus expectant management in mild male subfertility.
Study population:
Subfertile couples with pre-wash TMSC 6-10 million.
Intervention:
3 cycles of IUI, followed by 3 cycles of IUI-controlled ovarian hyper-stimulation (COH).
Control:
Expectant management (EM). Treatment time horizon 6 months.
Main study parameters/endpoints:
Primary: Ongoing pregnancy leading to live birth.
Secondary: Time to pregnancy, miscarriage, multiple pregnancy, live birth, perinatal outcome, (in-)direct costs, quality of life and patient preferences.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
As we compare interventions that are already applied in current practice, no additional risks or burdens are expected from the study.
Study objective
To evaluate the cost-effectiveness of therapies for male subfertility.
Study design
Primary and secondary outcomes within 6 months after randomisation.
Intervention
3 cycles of IUI, followed by 3 cycles of IUI-COH versus expectant management.
Inclusion criteria
1. Age female partner: 18-38 years;
2. Failure to conceive: 12-36 months;
3. Male subfertility: Pre-wash TMSC 6-10.10^6.
Exclusion criteria
1. Severe male subfertility: Pre-wash TMSC < 6.10^6;
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
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 |
|---|---|
| NTR-new | NL3632 |
| NTR-old | NTR3820 |
| Other | ZonMW : 837002003 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |