|- candidate number||1371|
|- NTR Number||NTR203|
|- Date ISRCTN created||8-feb-2006|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||12-sep-2005|
|- Secondary IDs||2 |
|- Public Title||The effectiveness of intrauterine insemination in subfertile couples with an isolated cervical factor: a randomised controlled trial.|
|- Scientific Title||The effectiveness of intrauterine insemination in subfertile couples with an isolated cervical factor: a randomised controlled trial.|
|- ACRONYM||subfertility, cervical factor, IUI|
|- hypothesis||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.|
|- Healt Condition(s) or Problem(s) studied||Subfertility|
|- Inclusion criteria||Couples with a cervical factor and otherwise no factors that reduced their fertility, i.e. a prognosis for a treatment independent ongoing pregnancy in the next year higher than 30%. A cervical factor was diagnosed by a well-timed, non-progressive post-coital test (PCT) with normal semen parameters.|
|- Exclusion criteria||All other subfertile couples.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jun-2002|
|- planned closingdate||1-jul-2005|
|- Target number of participants||100|
|- 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. 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.
|- Primary outcome||The primary endpoint was ongoing pregnancy within six months. Ongoing pregnancy was defined as the presence of foetal cardiac activity at transvaginal sonography at a gestational age of at least 12 weeks.|
|- Secondary outcome||Secondary endpoints were total number of clinical pregnancies, miscarriages and multiple pregnancies.|
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES|| P. Steures|
|- CONTACT for SCIENTIFIC QUERIES|| P. Steures|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Publications||Fertil Steril. 2007 Dec;88(6):1692-6. Epub 2007 May 7. |
Partly presented in an oral presentation at the Conjoint Annual Meeting of the American Societty for Reproductive Medicine and the Canadian Fertility and Andrology Society, ASRM/CFAS 2005, Montreal, Quebec, Canada.
|- Brief summary||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.
Randomised controlled trial.
17 fertility centres in The Netherlands.
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.
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.
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.
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.
|- Main changes (audit trail)|
|- RECORD||5-sep-2005 - 28-aug-2008|