|- candidate number||14266|
|- NTR Number||NTR3820|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||26-jan-2013|
|- Secondary IDs||837002003 ZonMW|
|- Public Title||Cost-effectiveness of IUI, IVF and ICSI for male subfertility. The MAle Subfertility Therapy
|- Scientific Title||Cost-effectiveness of IUI, IVF and ICSI for male subfertility. The MAle Subfertility Therapy
|- hypothesis||To evaluate the cost-effectiveness of therapies for male subfertility.|
|- Healt Condition(s) or Problem(s) studied||Male subfertility, Cost-effectiveness , Tailored expectant management, Intra-uterin insemination (IUI)|
|- 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).
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jun-2013|
|- planned closingdate||31-mei-2017|
|- Target number of participants||340|
|- Interventions||3 cycles of IUI, followed by 3 cycles of IUI-COH versus expectant management.|
|- 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.|
|- Timepoints||Primary and secondary outcomes within 6 months after randomisation. |
|- Trial web site||www.studies-obsgyn.nl|
|- CONTACT FOR PUBLIC QUERIES||Dr. J.P. Bruin, de|
|- CONTACT for SCIENTIFIC QUERIES||Dr. J.P. Bruin, de|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Rationale: |
We hypothesize that less invasive therapies are equally effective as more invasive therapies for male subfertility.
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.
IUI versus expectant management in mild male subfertility.
Subfertile couples with pre-wash TMSC 6-10 million.
3 cycles of IUI, followed by 3 cycles of IUI-controlled ovarian hyper-stimulation (COH).
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.
|- Main changes (audit trail)|
|- RECORD||26-jan-2013 - 4-feb-2013|