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SETI

Single Embryo Transfer or IUI

Treatment of couples with unexplained subfertility and an unfavourable prognosis.
A randomised trial comparing the effectiveness of IUI with ovarian hyperstimulation and IVF with single embryo transfer.

 

Go to the SETI webpage
For randomisations go to the SETI website

Background
Couples with unexplained or mild male subfertility and a small chanceof spontaneous pregnancy (<30%, calculated by the validated model ofHunault (Hunault et al., 2005, Van der Steeg et al., Submitted)), are currently treated with Intrauterine Insemination (IUI) and Controlled Ovarian Hyperstimulation (COH). This treatment results in 10-20%multiple pregnancies. Multiple pregnancies more often result in obstetrical and neonatal complications- e.g. premature birth, growth retardation and preeclampsia. These complicated pregnancies result in higher medical costs. Usually these subfertile patients are treatedwith IUI-COH followed by In Vitro Fertilization (IVF) with DoubleEmbryo Transfer (DET). An alternative strategy to prevent multiples would be IVF with Single Embryo Transfer (SET), and cryopreservation of spare embryos. However, it is unclear if this treatment is just as effective as IUI for these patients.

Objective
Our hypothesis is that one cycle of IVF-SETfollowed by embryo-transfers of cryo-preserved embryos is comparable to three cycles of IUI-COH concerning ongoing pregnancy and costs of these treatments. Multiple pregnancies however are largely prevented. Our aimis to test our hypothesis in 100 subfertile couples which would in our setting normally have been treated with IUI-COH.

Study design
The study design is a multi centre randomised clinical trial.

Population
Couples presenting at the clinic with unexplained subfertility or mild male infertility and poor fertility prospects. Poor fertility prospects are defined as a prognosis of treatment-independent pregnancy < 30% within 12 months. Age between 18 and 36 years.

Intervention and follow-up
GNRH agonist long luteal protocolwith recombinant 150 IU FSH subcutaneously followed by oocyte retrieval and SET or COH with recombinant FSH daily 75 IU subcutaneously followed by hCG and subsequent IUI. Follow-up will be until three cycles ofIUI-COH or one cycle of IVF-eSET has been completed with a time horizon of four months, or after ongoing pregnancy.

Outcome measures and analysis
The primary outcome measure inboth groups is ongoing pregnancy. Secondary outcomes are multiple pregnancies, clinical pregnancies, life birth and complications duringp regnancy. The effectiveness of one cycle of IVF-eSET versus threecycles of IUI-COH will be expressed as a rate ratio for ongoing pregnancy with corresponding 95% confidence intervals. A formal test of the difference in pregnancy rate will be performed using chi-squaretest statistics. All analyses will be performed on an intention-to-treat basis.
Considering an ongoing pregnancy rate of 30% in both treatment groups,with an alpha of 5% and a beta of 20%, 166 patients per group arerequired to exclude a difference of 12.5% or more to the detriment of IVF-SET.

Participating hospitals
Academic Medical Centre Amsterdam, Medisch Spectrum Twente Enschede, Maxima Medical Centre Veldhoven, OnzeLieve Vrouwe Gasthuis Amsterdam, St. Radboud Hospital Nijmegen, Erasmus Medical Centre Rotterdam, Vrije Universiteit Medical Centre Amsterdam,University Hospital Utrecht.