Condition category
Pregnancy and Childbirth
Date applied
30/05/2007
Date assigned
30/05/2007
Last edited
06/06/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.uzgent.be/EN/

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

Publication citations

Additional files

Editorial Notes