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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR961 |
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Date of registration:
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16/04/2007 |
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Primary sponsor: |
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Public title:
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A multi-centre, randomized, double-blind trial studying the effect of misoprostol on the outcome of intra-uterine insemination.
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Scientific title:
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A multi-centre, randomized, double-blind trial studying the effect of misoprostol on the outcome of intra-uterine insemination. - A multi-centre, randomized, double-blind trial studying the effect of misoprostol on the outcome of intra-uterine insemination. |
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Date of first enrolment:
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1/10/2003 |
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Target sample size:
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217 |
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Recruitment status: |
complete |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=961 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: Double; Control: Placebo; Group: Crossover; Type: 2 or more arms, randomized
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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M.
Dhont |
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Address:
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Universitair Ziekenhuis Gent, Vrouwenziekten,
De Pintelaan 185
9000
Gent
Belgium |
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Telephone:
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+32 92403796 |
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Email:
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Marc.Dhont@Ugent.be |
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Affiliation:
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Name:
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M.
Dhont |
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Address:
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Universitair Ziekenhuis Gent, Vrouwenziekten,
De Pintelaan 185
9000
Gent
Belgium |
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Telephone:
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+32 92403796 |
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Email:
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Marc.Dhont@Ugent.be |
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Affiliation:
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Key inclusion & exclusion criteria
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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.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Pregnancy, Intra-uterine insemination (IUI), Misoprostol , Prostaglandin, Vaginal suppository
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Intervention(s)
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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.
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Primary Outcome(s)
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Primary outcome is clinical pregnancy defined as the presence of a fetal sac with positive cardial activity.
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Secondary Outcome(s)
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Secondary endpoints are adverse reactions: uterine cramps and vaginal bleeding.
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Secondary ID(s)
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ISRCTN76424181
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Source(s) of Monetary Support
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Vlaamse vereniging voor obstetrie en gynaecologie
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