|- candidate number||16798|
|- NTR Number||NTR4462|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||11-mrt-2014|
|- Secondary IDs||2013_364 METC AMC|
|- Public Title||Artficial insemination with donor sperm: intrauterine or intra cervical insemination?|
|- Scientific Title||Artficial insemination with donor sperm: intrauterine or intra cervical insemination?|
|- hypothesis||In women treated with donor sperm ICI is non inferior as compared to IUI.|
|- Healt Condition(s) or Problem(s) studied||Intra-uterine insemination (IUI), Artificial insemination with donor sperm (AID)|
|- Inclusion criteria||Indications for AID
o Couples with azoospermia
o Couples with failed TESE procedure
o Couples with a partner with a hereditary genetic defect
o Lesbian couples
o Single women
- Regular cycle
- Women with anovulation who become ovulatory after ovulation induction|
|- Exclusion criteria||- Double sided tubal pathology
- women with a history of subfertility, other than male factor
- Women younger than 18 or older than 43 years|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-feb-2014|
|- planned closingdate||1-feb-2017|
|- Target number of participants||416|
|- Interventions||6 cycles of IUI or 6 cycles of ICI without the addition of ovarian hyperstimulation.|
|- Primary outcome||ongoing pregnancy leading to a live brith|
|- Secondary outcome||1. clinical pregnancy rate
2. miscarriage rate
3. multiple pregnancy rate
4. time to ongoing pregnancy rate
5. pregnancy complications (preterm birth, preeclampsia)
6. direct and indirect costs|
|- Timepoints||8 months after randomisation|
|- Trial web site||http://www.studies-obsgyn.nl/AID-study|
|- CONTACT FOR PUBLIC QUERIES||MD. M.H. Mochtar|
|- CONTACT for SCIENTIFIC QUERIES||MD. M.H. Mochtar|
|- 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||Background
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.
Intervention [or: Methods]
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)
Nature and extent of the burden and risks associated with participation, benefit and group relatedness The strategies compared are already broadly applied in current practice. No additional risks are expected. There is no benefit for participants, but the results may benefit future women apllying for AID.|
|- Main changes (audit trail)|
|- RECORD||11-mrt-2014 - 11-apr-2014|