Prevention of multiple pregnancies in couples with unexplained or mild male subfertility

In couples with unexplained subfertility or mild male subfertility and an unfavourable prognosis for conception intra-uterine insemination with controlled ovarian hyperstimulation is standard treatment. The disadvantage of the adjuvant ovarian hyperstimulation is the risk of multiple pregnancies leading to maternal and neonatal complications. Single embryo transfer (SET) either in IVF cycles with mild ovarian hyperstimulation or in the manipulated natural cycle IVF are alternative treatments that prevent multiple pregnancies.

The aim of this study is to reduce multiple pregnancies while retaining acceptable delivery rates in couples with unexplained subfertility or mild male subfertility that have a low chance of a treatment independent pregnancy. We therefore compare six cycles of intra-uterine insemination with controlled ovarian hyperstimulation, six cycles of manipulated natural cycle IVF, and three cycles with IVF-eSET plus cryo-cycles within a time frame of 10 months.
All academic centers and their affiliated clinics in the Netherlands will participate in this multicenter trial. A total of 600 couples will be included.
We will compare the primary outcome of birth of a healthy child, multiple pregnancy, the costs, and women’s experience to the treatments in the three groups..
A cost-effectiveness analysis will be performed with costs of treatment until 6 weeks after the delivery of a child within a treatment time horizon of 10 months

Multiple pregancies can be prevented without loss of pregnancy rates by treating couples with manipulated natural cycle IVF or with IVF-eSET plus cryo-cycles instead of standard treatment with intra-uterine insemination and controlled ovarian hyperstimulation.

The comparisons are six cycles of intra-uterine insemination with controlled ovarian hyperstimulation, six cycles of manipulated natural cycle IVF, and three cycles with IVF-eSET plus cryo-cycles within a time frame of 10 months.