| - candidate number | 2551 |
| - NTR Number | NTR961 |
| - ISRCTN | ISRCTN76424181 |
| - Date ISRCTN created | 30-mei-2007 |
| - date ISRCTN requested | 22-mei-2007 |
| - Date Registered NTR | 16-apr-2007 |
| - Secondary IDs | |
| - Public Title | A multi-centre, randomized, double-blind trial studying the effect of misoprostol on the outcome of intra-uterine insemination. |
| - Scientific Title | A multi-centre, randomized, double-blind trial studying the effect of misoprostol on the outcome of intra-uterine insemination. |
| - ACRONYM | A multi-centre, randomized, double-blind trial studying the effect of misoprostol on the outcome of intra-uterine insemination. |
| - hypothesis | Pregnancy rate after insemination would be 50% higher after application of misoprostol. |
| - Healt Condition(s) or Problem(s) studied | Pregnancy, Intra-uterine insemination (IUI), Misoprostol , Prostaglandin, Vaginal suppository |
| - Inclusion criteria | 1. 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 criteria | 1. History of previously failed intra-uterine insemination; 2. Severe comorbidity (endometriosis, fibroma); 3. Previous allergic reactions to misoprostol. |
| - mec approval received | yes |
| - multicenter trial | yes |
| - randomised | yes |
| - masking/blinding | Double |
| - control | Placebo |
| - group | Crossover |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 1-okt-2003 |
| - planned closingdate | 30-jun-2005 |
| - Target number of participants | 217 |
| - Interventions | Before removing the speculum after IUI, a white study suppository is placed in het posterior vaginal fornix. Each suppository contains either placebo or 400 µg of misoprostol. |
| - Primary outcome | Primary outcome is clinical pregnancy defined as the presence of a fetal sac with positive cardial activity. |
| - Secondary outcome | Secondary endpoints are adverse reactions: uterine cramps and vaginal bleeding. |
| - Timepoints | N/A |
| - Trial web site | N/A |
| - status | stopped: trial finished |
| - CONTACT FOR PUBLIC QUERIES | Prof. Dr M. Dhont |
| - CONTACT for SCIENTIFIC QUERIES | Prof. 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 |
| - Publications | Gynecol Obstet Invest. 2008 May 20;66(3):145-151. [Epub ahead of print] |
| - Brief summary | Because 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) | |
| - RECORD | 16-apr-2007 - 9-jul-2008 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl