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


- candidate number14266
- NTR NumberNTR3820
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-jan-2013
- Secondary IDs837002003 ZonMW
- Public TitleCost-effectiveness of IUI, IVF and ICSI for male subfertility. The MAle Subfertility Therapy Effectiveness Rcts.
- Scientific TitleCost-effectiveness of IUI, IVF and ICSI for male subfertility. The MAle Subfertility Therapy Effectiveness Rcts.
- ACRONYMMASTER
- hypothesisTo evaluate the cost-effectiveness of therapies for male subfertility.
- Healt Condition(s) or Problem(s) studiedMale subfertility, Cost-effectiveness , Tailored expectant management, Intra-uterin insemination (IUI)
- Inclusion criteria1. Age female partner: 18-38 years;
2. Failure to conceive: 12-36 months;
3. Male subfertility: Pre-wash TMSC 6-10.10^6.
- Exclusion criteria1. 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 receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2013
- planned closingdate31-mei-2017
- Target number of participants340
- Interventions3 cycles of IUI, followed by 3 cycles of IUI-COH versus expectant management.
- Primary outcomeOngoing pregnancy leading to live birth within the treatment time horizon.
- Secondary outcomeTime 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.
- TimepointsPrimary and secondary outcomes within 6 months after randomisation.
- Trial web sitewww.studies-obsgyn.nl
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. J.P. Bruin, de
- CONTACT for SCIENTIFIC QUERIESDr. J.P. Bruin, de
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryRationale:
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.
- Main changes (audit trail)
- RECORD26-jan-2013 - 4-feb-2013


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