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
Protocol serial number	NL936 (NTR961)
Sponsor	University Hospital Ghent (Belgium)
Funder	Flemish Association for Obstetrics and Gynaecology (Vlaamse Vereniging voor Obstetrie en Gynaecologie) (Belgium)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr M. Dhont
Scientific

Universitair Ziekenhuis Gent
Vrouwenziekten
De Pintelaan 185
Geent
9000
Belgium

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

Primary study design	Interventional
Study design	Randomised, multicentre, double blinded, placebo controlled, crossover trial
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Misoprostol
Primary outcome measure(s)	Clinical pregnancy defined as the presence of a intra-uterine fetal sac with positive cardial activity 5 weeks after insemination.
Key secondary outcome measure(s)	Adverse reactions: uterine cramps and vaginal bleeding until 24 hours after insemination.
Completion date	30/06/2005

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	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

Universitair Ziekenhuis Gent

Geent
9000
Belgium

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

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

19/10/2021: Publication reference added.