|- candidate number||1372|
|- NTR Number||NTR204|
|- Date ISRCTN created||8-feb-2006|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||12-sep-2005|
|- Secondary IDs||3 |
|- Public Title||A randomised clinical trial assessing the additional value of ovarian hyperstimulation in intrauterine insemination for couples with an abnormal post-coital test.|
|- Scientific Title||A randomised clinical trial assessing the additional value of ovarian hyperstimulation in intrauterine insemination for couples with an abnormal post-coital test.|
|- ACRONYM||subfertility, cervical factor, IUI, ovarian hyperstimulation|
|- hypothesis||We hypothesized that controlled ovarian hyperstimulation (COH) is of additional value to IUI in couples with a cervical factor and a poor prognosis, i.e. < 30% spontaneous pregnancy chance in the next year. |
|- Healt Condition(s) or Problem(s) studied||Subfertility|
|- Inclusion criteria||Couples were eligible if they had an abnormal PCT, either due to cervical hostility diagnosed by a well-timed, non-progressive PCT with normal semen parameters or due to a poor semen quality.|
The spontaneous pregnancy chance in the next year, leaving the result of the PCT out of consideration, was < 30%.
|- 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||250|
|- Interventions||These couples were randomly allocated to three cycles IUI with COH or three cycles IUI without COH. |
Controlled ovarian hyperstimulation as well as ovulation detection- induction, semen preparation and insemination regimens were performed according to hospital-specific protocols.
|- Primary outcome||The primary endpoint was ongoing pregnancy within three cycles of IUI. |
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||stopped: trial finished|
|- 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):1618-24. Epub 2007 Jun 11. |
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||Objective: |
At present, there is only one non-randomised study that assesses the effectiveness of controlled ovarian hyperstimulation (COH) in intrauterine insemination (IUI) for subfertile couples with a cervical factor. We evaluated the contribution of COH in couples with an abnormal post-coital test (PCT) undergoing IUI.
Randomised clinical trial.
Materials and methods:
We performed a randomised clinical trial in 24 Fertility Centers in The Netherlands. Couples were eligible if they had an abnormal PCT, either due to cervical hostility diagnosed by a well-timed, non-progressive PCT with normal semen parameters or due to a poor semen quality. These couples were randomly allocated to three cycles IUI with COH or three cycles IUI without COH.
The primary endpoint:
was ongoing pregnancy within three IUI cycles. The treatment effect was expressed as a relative risk and 95% confidence interval (CI). The analysis was performed according the intention to treat principle. In a subgroup-analysis, we evaluated the follicular growth patterns in relation to the occurrence of pregnancy. We assumed an equal effect in both groups with an ongoing pregnancy rate of 18% after 3 cycles. To show this equivalence with a maximum difference of 12%, an alpha of 5% and a power of 80%, 117 couples were required in each group.
At present, 250 couples have been included, and follow up for three cycles is available for 205 couples. In the IUI without COH group, 20 couples (19%) became pregnant of which 18 had an ongoing pregnancy (17%). In the IUI with COH group, 25 couples (26%) became pregnant, of which 23 had an ongoing pregnancy (24%). The relative risk of an ongoing pregnancy was 1.4 (95% CI 1.0 to 1.9). Two multiple pregnancies occurred in the IUI with COH group (8.7% of the ongoing pregnancies).
The fraction of IUI cycles with multifollicular growth was 43% in IUI with COH versus 3% in IUI without COH. Pregnancy rates with or without multifollicular growth were 9.5% and 11% per cycle, respectively, with ongoing pregnancy rates of 6.8% and 10% per cycle.
This trial suggests that COH has an additional effect to IUI in couples with an abnormal PCT.
|- Main changes (audit trail)|
|- RECORD||5-sep-2005 - 28-aug-2008|