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

ISRCTN ISRCTN76424181
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

Universitair Ziekenhuis Gent
Vrouwenziekten
De Pintelaan 185
Geent
9000
Belgium

Phone +32 (0)9 2403796
Email Marc.Dhont@Ugent.be

Study information

Study designRandomised, multicentre, double blinded, placebo controlled, crossover trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleA multi-centre, randomised, double-blind trial studying the effect of misoprostol on the outcome of intra-uterine insemination
Study objectivesPregnancy 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) studiedPregnancy, prostaglandin, misoprostol, vaginal suppository, Intra-Uterine Insemination (IUI)
InterventionBefore 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Misoprostol
Primary outcome measureClinical pregnancy defined as the presence of a intra-uterine fetal sac with positive cardial activity 5 weeks after insemination.
Secondary outcome measuresAdverse reactions: uterine cramps and vaginal bleeding until 24 hours after insemination.
Overall study start date01/10/2003
Completion date30/06/2005

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants217
Key inclusion criteria1. 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 criteria1. History of previously failed intra-uterine insemination
2. Severe comorbidity (endometriosis, fibroma)
3. Previous allergic reactions to misoprostol
Date of first enrolment01/10/2003
Date of final enrolment30/06/2005

Locations

Countries of recruitment

  • Belgium
  • Netherlands

Study participating centre

Universitair Ziekenhuis Gent
Geent
9000
Belgium

Sponsor information

University Hospital Ghent (Belgium)
Hospital/treatment centre

Department of Gynaecology
De Pintelaan 185
Gent
B-9000
Belgium

Website http://www.uzgent.be/EN/
ROR logo "ROR" 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 01/10/2008 19/10/2021 Yes No

Editorial Notes

19/10/2021: Publication reference added.