The effectiveness of intrauterine insemination in subfertile couples with an isolated cervical factor: a randomised controlled trial.

Objectives:

To assess the effectiveness of intrauterine insemination (IUI) in subfertile couples with a cervical factor. The effectiveness of IUI is well established for male and unexplained subfertility. Data on IUI for cervical factor subfertility from five small trials are conflicting.




Design:

Randomised controlled trial.




Setting:

17 fertility centres in The Netherlands.




Participants:

Subfertile couples with a cervical factor, diagnosed by a well-timed, non-progressive post-coital test (PCT) with normal semen parameters and otherwise no factors that reduced fertility.




Interventions:

Couples were randomly allocated to IUI for six months or expectant management for six months. In the first three IUI cycles no controlled ovarian hyperstimulation (COH) was given. If these attempts failed subsequent IUI cycles were performed with COH.




Main outcome measures:

Ongoing pregnancy within 6 months, resulting in the live birth of at least one child.




Results:

We randomised 101 couples, xx couples were allocated to IUI and xx couples were allocated to expectant management. In the IUI group, xx couples (xx%) conceived, of which xx resulted in live birth (xx%). In the expectant management group, xx couples (xx%) conceived, of which xx resulted in live birth (xx%). (Relative risk 1.5 95% CI 0.99 to 2.2). The number of multiple pregnancies in both groups was xx.




Conclusions:

This trial suggest a beneficial effect of IUI in couples with an isolated cervical factor. This effect should be considered by those who plea against performance of the post-coital test.

We hypothesized a beneficial effect of IUI in couples with an isolated cervical factor. Furthermore we hypothesized that the post-coital test can identify those couples who would benefit from IUI without ovarian hyperstimulation.

N/A

Couples were randomly allocated to IUI for six months or expectant management for six months. In the first three IUI cycles no controlled ovarian hyperstimulation (COH) was given. If these attempts failed subsequent IUI cycles were performed with COH. Couples allocated to expectant management were followed till an ongoing pregnancy occurred within six months.
If no pregnancy occurred, follow-up ended after this period.
If a pregnancy miscarried, follow-up continued until the next pregnancy or the end of the six months period.