Contact information
Type
Scientific
Primary contact
Prof. M. Dhont
ORCID ID
Contact details
Universitair Ziekenhuis Gent
Vrouwenziekten
De Pintelaan 185
Geent
9000
Belgium
+32 (0)9 2403796
Marc.Dhont@Ugent.be
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Pregnancy rate after insemination would be 50% higher after application of misoprostol.
Ethics approval
Ethics Committee of University Hospital, De Pintelaan 185, 9000 Gent. Date of approval 17 May 2001. Project No. 2001/137.
Study design
Randomised, multicentre, double blinded, placebo controlled, crossover trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Pregnancy, prostaglandin, misoprostol, vaginal suppository, Intra-Uterine Insemination (IUI)
Intervention
Before removing the speculum after IUI, a white study suppository is placed in the posterior vaginal fornix. Each suppository contains either placebo or 400 µg of misoprostol.
Intervention type
Drug
Phase
Not Specified
Drug names
Misoprostol
Primary outcome measures
Clinical pregnancy defined as the presence of a intra-uterine fetal sac with positive cardial activity 5 weeks after insemination.
Secondary outcome measures
Adverse reactions: uterine cramps and vaginal bleeding until 24 hours after insemination.
Overall trial start date
01/10/2003
Overall trial end date
30/06/2005
Reason abandoned
Eligibility
Participant inclusion criteria
1. All women presenting for Intra-Uterine Insemination (IUI)
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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
217
Participant exclusion criteria
1. History of previously failed intra-uterine insemination
2. Severe comorbidity (endometriosis, fibroma)
3. Previous allergic reactions to misoprostol
Recruitment start date
01/10/2003
Recruitment end date
30/06/2005
Locations
Countries of recruitment
Netherlands
Trial participating centre
Universitair Ziekenhuis Gent
Geent
9000
Belgium
Sponsor information
Organisation
University Hospital Ghent (Belgium)
Sponsor details
Department of Gynaecology
De Pintelaan 185
Gent
B-9000
Belgium
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Flemish Association for Obstetrics and Gynaecology (Vlaamse Vereniging voor Obstetrie en Gynaecologie) (Belgium)
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