To evaluate the cost-effectiveness of therapies for male subfertility.
ID
Bron
Verkorte titel
Aandoening
Male subfertility (mannelijke subfertiliteit), cost-effectiveness (kosteneffectiviteit), Expectant management (afwachtend beleid), IUI
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Ongoing pregnancy leading to live birth within the treatment time horizon.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
To evaluate the cost-effectiveness of therapies for male subfertility.
Onderzoeksopzet
Primary and secondary outcomes within 6 months after randomisation.
Onderzoeksproduct en/of interventie
3 cycles of IUI, followed by 3 cycles of IUI-COH versus expectant management.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Age female partner: 18-38 years;
2. Failure to conceive: 12-36 months;
3. Male subfertility: Pre-wash TMSC 6-10.10^6.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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).
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3632 |
| NTR-old | NTR3820 |
| Ander register | ZonMW : 837002003 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |