Contact information
Type
Scientific
Primary contact
Dr I. Custers
ORCID ID
Contact details
Academic Medical Centre (AMC)
Department of Obstetrics and Gynecology
Centre for Reproductive Medicine
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 566 4355
i.m.custers@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR426
Study information
Scientific title
Acronym
Study hypothesis
Does a short time of immobilisation (i.e., 15 minutes) after Intra-Uterine Insemination (IUI) have a potential advantage on pregnancy rates, compared to immediate mobilisation and does it outweigh the disadvantage of the extra time and working space it consumes?
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Randomised controlled parallel group multicentre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Subfertility
Intervention
Intra uterine insemination will be performed in spontaneous cycles as well in cycles with Controlled Ovarian Hyper-stimulation (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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Ongoing pregnancy
Secondary outcome measures
Biochemical, clinical, ectopic pregnancy.
Overall trial start date
01/09/2005
Overall trial end date
01/09/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All patients, receiving IUI with fresh or cryo-preserved donor- or husbands sperm IUI with or without Controlled Ovarian Hyper-stimulation (IUI-COH), as a treatment for their subfertility will be eligible for the trial.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
280
Participant exclusion criteria
1. Tubal pathology of both fallopian tubes
2. Patients younger than 18 years or older than 43 years of age
Recruitment start date
01/09/2005
Recruitment end date
01/09/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Centre (AMC)
Amsterdam
1100 DD
Netherlands
Sponsor information
Organisation
Academic Medical Centre (AMC) (Netherlands)
Sponsor details
Center For Reproductive Medicine
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Academic Medical Centre (AMC) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19875843
Publication citations
-
Results
Custers IM, Flierman PA, Maas P, Cox T, Van Dessel TJ, Gerards MH, Mochtar MH, Janssen CA, van der Veen F, Mol BW, Immobilisation versus immediate mobilisation after intrauterine insemination: randomised controlled trial., BMJ, 2009, 339, b4080.