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Anything Else for the Homework group?? The HysteroSalpingoGraphy in women with NO Tubal Pathology: Do it with Lipiodol UltraFluide? Very Thin Evidence... This article is protected by copyright. All rights reserved. ig re .ti MOS/IUI vs Homework in Couples with 1 year Prognosis < 30% Where is the real large trial in Unexplained Infertility? Double Blind? Obstetrics Fertility Follow Up Gynaecological (Uro)gynaecology Oncology Quality Documents Links Search MOS/IUI compared to Homework: Study CRASHED after 2 year, WITH ONLY 22 INCLUSIONS, POWER NEEDED WAS 1020. Many eligibles, participation rate very low both for the patient as well as the docter. Home New Trials Fertility Contact Fetal medicine Mission Results Consortium studies Planned studies for new trials look on the website What is the effectiveness of IUI-OH in couples with unexplained or mild male subfertility and a poor prognosis on natural conception? Go to the EXIUI website De EXIUI studie is het NVOG SEENEZ project. SEENEZ staat voor Stimuleer Effectieve En Background Of the 20,000 couples who yearly seek fertility treatment, more than 50% are diagnosed with unexplained or mild male factor subfertility. In The Netherlands, the first line treatment for these women is intrauterine insemination with ovarian hyperstimulation (IUI-OH) if the probability of a natural conception within the following year is lower than 30% according to the validated model of Hunault. An estimated 28,500 cycles are conducted every year in the Netherlands, costing approximately 20 million euros, without any evidence that IUI-OH increases live birth rate compared to expectant management. Besides the costs, IUI-OH bears a risk of multiple pregnancies. Women with a multiple pregnancy have an increased risk of premature birth, with associated neonatal mortality and morbidity. Objective To evaluate whether expectant management for 6 months does not lead to a decrease in ongoing pregnancy rate leading to a live birth compared to 6 months IUI-OH. Study design Randomized multicentre, non-inferiority trial with cost-effectiveness analysis. Study population Couples of all ethnicities with a female age between 18 and 42 year diagnosed with unexplained or mild male subfertility and an unfavourable prognosis of natural conception. Intervention Six months expectant management (experimental arm) and six months IUI-OH (standard or control arm). Outcome measures The primary outcome is ongoing pregnancy leading to a live birth conceived within 6 months after randomization. Power/data analysis We expect a 30% live birth rate after 6 months IUI-COH. To evaluate whether 6 months expectant management does not result in a decrease of an ongoing pregnancy rate of 6%, we need 1.052 patients. (power 80%, alpha error 0.05). Anticipating 10% lost to follow up, we need to randomise 1,169 women. CEA/ BIA: In case expectant management does not lead to a decrease of more than 6% in efficiency, de-implementation of IUI-OH will follow, leading to annual cost savings of 20 million Euros. Economic evaluation The economic evaluation will be designed as a cost-effectiveness analysis. https://www.zorgevaluatienederland.nl Inclusion ongoing ALIFE2 ANTARCTI... > exIUI FOAM IVF 38+ Medium II SCRaTCH ... SelecTIMO STIM T4-LIFE TRUST ZinenZwa... Inclusion completed SCRaTCH Completed studies ALIFE Bedrust ESEP H2Olie Freeze-all (progesterone) IMPROvEMENT INeS inSIGHT Lifestyle MASTER M-ovin" OPTIMIST Promise PRORAILS SUPER Non-Consortium studies AID-study Antarctica study Congeno study DESH trial ENDO-RECEPT Follikel diameter IVM study L-Age Elimineer Niet Effectieve Zorg. EXIUI study 102 99