A multi-centre, randomised, double-blind trial studying the effect of misoprostol on the outcome of intra-uterine insemination
ISRCTN | ISRCTN76424181 |
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DOI | https://doi.org/10.1186/ISRCTN76424181 |
Secondary identifying numbers | NL936 (NTR961) |
- Submission date
- 30/05/2007
- Registration date
- 30/05/2007
- Last edited
- 19/10/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr M. Dhont
Scientific
Scientific
Universitair Ziekenhuis Gent
Vrouwenziekten
De Pintelaan 185
Geent
9000
Belgium
Phone | +32 (0)9 2403796 |
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Marc.Dhont@Ugent.be |
Study information
Study design | Randomised, multicentre, double blinded, placebo controlled, crossover trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | A multi-centre, randomised, double-blind trial studying the effect of misoprostol on the outcome of intra-uterine insemination |
Study objectives | Pregnancy rate after insemination would be 50% higher after application of misoprostol. |
Ethics approval(s) | Ethics Committee of University Hospital, De Pintelaan 185, 9000 Gent. Date of approval 17 May 2001. Project No. 2001/137. |
Health condition(s) or problem(s) studied | 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 |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Misoprostol |
Primary outcome measure | 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 study start date | 01/10/2003 |
Completion date | 30/06/2005 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Female |
Target number of participants | 217 |
Key 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 |
Key exclusion criteria | 1. History of previously failed intra-uterine insemination 2. Severe comorbidity (endometriosis, fibroma) 3. Previous allergic reactions to misoprostol |
Date of first enrolment | 01/10/2003 |
Date of final enrolment | 30/06/2005 |
Locations
Countries of recruitment
- Belgium
- Netherlands
Study participating centre
Universitair Ziekenhuis Gent
Geent
9000
Belgium
9000
Belgium
Sponsor information
University Hospital Ghent (Belgium)
Hospital/treatment centre
Hospital/treatment centre
Department of Gynaecology
De Pintelaan 185
Gent
B-9000
Belgium
Website | http://www.uzgent.be/EN/ |
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https://ror.org/00xmkp704 |
Funders
Funder type
Research organisation
Flemish Association for Obstetrics and Gynaecology (Vlaamse Vereniging voor Obstetrie en Gynaecologie) (Belgium)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | 01/10/2008 | 19/10/2021 | Yes | No |
Editorial Notes
19/10/2021: Publication reference added.