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Artificial insemination with donor sperm: Intra uterine or intra cervical insemination?
In the Netherlands, artificial insemination with donor sperm (AID) is widely performed since 1948. To prevent transmission of sexually transmitted diseases such as Human Immunodeficiency Virus (HIV) and Hepatitis B and C), AID is performed with cryopreserved donor sperm even though pregnancy rates per cycle are lower for cryopreserved sperm than for fresh sperm. There are two techniques for insemination for AID; through the intrauterine (IUI) or the intracervical (ICI) route.
Recently, a Cochrane meta-analysis reported intrauterine insemination with controlled ovarian stimulation (IUI-COS) to be more effective then intracervical insemination with controlled ovarian stimulation (ICI-COS) using donor sperm in terms of live birth rate. However, both IUI-COS and ICI-COS were associated with high multiple pregnancy rates of 14.4% and 6.7% respectively. Therefore, in the Netherlands both insemination techniques are used without the addition of controlled ovarian stimulation.In addition, IUI is more expensive than ICI. These higher costs are generated by the costs involved in processing the sperm. IUI costs around 650 Euro per cycle, compared to 150 Euro per cycle for ICI Considering these uncertainties IUI may generate higher costs than ICI for no increase in pregnancies.
To assess if intracervical insemination with donor sperm is non-inferior to intrauterine insemination.
Nationial parallel multicenter randomized clinical trial, comparing IUI without controlled ovarian stimulation with ICI without controlled ovarian stimulation.
Women eligible for insemination with donor sperm.
A maximum of six cycles of IUI or ICI without controlled ovarian stimulation. In the first cycle one group receives IUI and the other group receives ICI. The time horizon will be eight months
Primary outcome is onging pregnancy rate leading to a live birth.
Secondary endpoints are clinical pregnancy rate, multiple pregnancy rate, pregnancy complications (preterm birth, preeclampsia), direct and indirect costs.
Assuming a live birth rate of 40% after six cycles of ICI and IUI, we need 208 women per arm (total 416 women) to demonstrate the non-inferiority of ICI (alpha .05, beta .80)
Approximately 1000 women a year start with artificial insemination with donor sperm (AID). IUI is performed in 80% of these women. For both the ICI and IUI treatment we assume that 40% of women will have a live birth within one year. When estimating the potential budget impact in case all women would be treated with ICI instead of IUI in case of non-inferiority the budget impact was estimated to be a saving of € 1.5 million.
A total of 36 Months will be needed: 3 Months preparation, 18 Months recruitment, 8 Months treatment, 4 Months Follow up en 3 Months analysis and report.
dr. M.H. Mochtar
dr. M. van Wely
Drs. P.A.L. Kop
T: 020-5669111, pager 59383