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A multi-centre, randomized, double-blind trial studying the effect of misoprostol on the outcome of intra-uterine insemination.


- candidate number2551
- NTR NumberNTR961
- ISRCTNISRCTN76424181
- Date ISRCTN created30-mei-2007
- date ISRCTN requested22-mei-2007
- Date Registered NTR16-apr-2007
- Secondary IDs 
- Public TitleA multi-centre, randomized, double-blind trial studying the effect of misoprostol on the outcome of intra-uterine insemination.
- Scientific TitleA multi-centre, randomized, double-blind trial studying the effect of misoprostol on the outcome of intra-uterine insemination.
- ACRONYMA multi-centre, randomized, double-blind trial studying the effect of misoprostol on the outcome of intra-uterine insemination.
- hypothesisPregnancy rate after insemination would be 50% higher after application of misoprostol.
- Healt Condition(s) or Problem(s) studiedPregnancy, Intra-uterine insemination (IUI), Misoprostol , Prostaglandin, Vaginal suppository
- Inclusion criteria1. All women presenting for intra-uterine insemination;
2. Between the age of 20 and 36 years;
3. Bilateral tubal patency was proven;
4. Total motile fraction of the semen sample was more than 1 million after preparation;
5. Informed consent.
- Exclusion criteria1. History of previously failed intra-uterine insemination;
2. Severe comorbidity (endometriosis, fibroma);
3. Previous allergic reactions to misoprostol.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2003
- planned closingdate30-jun-2005
- Target number of participants217
- InterventionsBefore removing the speculum after IUI, a white study suppository is placed in het posterior vaginal fornix. Each suppository contains either placebo or 400 g of misoprostol.
- Primary outcomePrimary outcome is clinical pregnancy defined as the presence of a fetal sac with positive cardial activity.
- Secondary outcomeSecondary endpoints are adverse reactions: uterine cramps and vaginal bleeding.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESProf. Dr M. Dhont
- CONTACT for SCIENTIFIC QUERIESProf. Dr M. Dhont
- Sponsor/Initiator University Hospital Ghent, dept of Gyneacology
- Funding
(Source(s) of Monetary or Material Support)
Vlaamse vereniging voor obstetrie en gynaecologie
- PublicationsGynecol Obstet Invest. 2008 May 20;66(3):145-151. [Epub ahead of print]
- Brief summaryBecause seminal prostaglandins play a role in the natural fertilization process, it can be hypothesized that the vaginal supplementation of exogenous prostaglandins at the time of intra-uterine insemination might enhance the chances of conception. We therefore investigate the effect of misoprostol, a prostaglandin analogue, on the success rate of intra-uterine insemination.
- Main changes (audit trail)
- RECORD16-apr-2007 - 9-jul-2008


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