Condition category
Pregnancy and Childbirth
Date applied
27/06/2007
Date assigned
27/06/2007
Last edited
02/11/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

Eligibility

Participant inclusion criteria

All 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.

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

http://www.amc.uva.nl

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

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19875843

Publication citations

  1. 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.

Additional files

Editorial Notes