Randomised controlled trial of bed rest versus no bed rest after intra-uterine insemination: impact on pregnancy rates

ISRCTN ISRCTN53294431
DOI https://doi.org/10.1186/ISRCTN53294431
Secondary identifying numbers NTR426
Submission date
27/06/2007
Registration date
27/06/2007
Last edited
02/11/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr I. Custers
Scientific

Academic Medical Centre (AMC)
Department of Obstetrics and Gynecology
Centre for Reproductive Medicine
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Phone +31 (0)20 566 4355
Email i.m.custers@amc.uva.nl

Study information

Study designRandomised controlled parallel group multicentre trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesDoes 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(s)Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studiedSubfertility
InterventionIntra 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 typeOther
Primary outcome measureOngoing pregnancy
Secondary outcome measuresBiochemical, clinical, ectopic pregnancy.
Overall study start date01/09/2005
Completion date01/09/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants280
Key inclusion criteriaAll patients, receiving IUI with fresh or cryo-preserved donor- or husband’s sperm IUI with or without Controlled Ovarian Hyper-stimulation (IUI-COH), as a treatment for their subfertility will be eligible for the trial.
Key exclusion criteria1. Tubal pathology of both fallopian tubes
2. Patients younger than 18 years or older than 43 years of age
Date of first enrolment01/09/2005
Date of final enrolment01/09/2007

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Academic Medical Centre (AMC)
Amsterdam
1100 DD
Netherlands

Sponsor information

Academic Medical Centre (AMC) (Netherlands)
Hospital/treatment centre

Center For Reproductive Medicine
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Website http://www.amc.uva.nl
ROR logo "ROR" https://ror.org/03t4gr691

Funders

Funder type

Hospital/treatment centre

Academic Medical Centre (AMC) (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 29/10/2009 Yes No