|- candidate number||1651|
|- NTR Number||NTR426|
|- Date ISRCTN created||27-jun-2007|
|- date ISRCTN requested||11-jun-2007|
|- Date Registered NTR||14-sep-2005|
|- Secondary IDs||N/A |
|- Public Title||Randomised controlled trial of bed rest versus no bed rest, after intra-uterine insemination, impact on pregnancy rates.
|- Scientific Title||Randomised controlled trial of bed rest versus no bed rest, after intra-uterine insemination, impact on pregnancy rates.
|- hypothesis||Does a short time of immobilization (i.e. 15 minutes) after intra-uterine insemination have a potential advantage on pregnancy rates, compared to immediate mobilization and does it outweigh the disadvantage of the extra time and working space it consumes?|
|- Healt Condition(s) or Problem(s) studied||Subfertility|
|- Inclusion criteria||All patients, receiving IUI with fresh or cryo-preserved donor- or husbandís sperm
IUI with or without controlled ovarian hyper stimulation (IUI-COH), as a treatment for their subfertility will be eligible for the trial.|
|- Exclusion criteria||1. Tubal pathology of both fallopian tubes;|
2. Patients younger than 18 years or older than 43 years of age.
|- mec approval received||yes|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2005|
|- planned closingdate||1-sep-2007|
|- Target number of participants||370|
|- Interventions||Intra uterine insemination will be performed in spontaneous cycles as well in cycles with controlled ovarian hyperstimulation (IUI-COH). IUI will be performed in lithotomy position with Trendelenburg tilt. After the insemination has been performed, the patient will, according to their allocation, immediately stand up and go home, or will return to normal supine position, and remain so for 15 minutes.|
|- Primary outcome||Ongoing pregnancy. |
|- Secondary outcome||Biochemical, clinical, ectopic pregnancy.|
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||MD. I. Custers|
|- CONTACT for SCIENTIFIC QUERIES||MD. PhD. Fulco Veen, van der|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Center For Reproductive Medicine |
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC), Center For Reproductive Medicine|
|- Brief summary||Homologous and heterologous intra uterine insemination (IUI) is a commonly used treatment for couples with male, cervical and unexplained subfertility. The reported success rate of this therapy in terms of pregnancy and ongoing pregnancy, varies greatly, and is both dependent on the cause of subfertility as well as on the procedure that is used. Different variables in this IUI procedure have been well investigated. One of the issues that remains unresolved is the question whether after insemination the patient can immediately mobilize or should stay in supine position for a short period of time.
We designed a multicentre trial to answer the question if a short time of immobilization (i.e. 15 minutes) has a potential advantage on pregnancy rates after intra-uterine insemination, over immediate mobilization.
All patients, receiving IUI with fresh or cryo-preserved donor- or husbandís sperm and IUI with or without controlled ovarian hyper stimulation (IUI-COH), as a treatment for their subfertility are eligible for the trial.
Follow up of each included patient will be until 3 cycles of IUI, or in case of pregnancy, until 12 weeks of gestation (ongoing pregnancy).
To answer the question whether bed rest is superior over immediate mobilisation after IUI, 185 couples are needed in each arm.
|- Main changes (audit trail)|
|- RECORD||14-sep-2005 - 5-jan-2010|