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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29376

Enrollment

217

Registered

2007-04-16

Start date

2003-10-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intra-uterine insemination, misoprostol, pregnancy, prostaglandin, vaginal suppository.

Interventions

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.

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. History of previously failed intra-uterine insemination; 2. Severe comorbidity (endometriosis, fibroma); 3. Previous allergic reactions to misoprostol.

Design outcomes

Primary

Measure	Time frame
Primary outcome is clinical pregnancy defined as the presence of a fetal sac with positive cardial activity.	—

Secondary

Measure	Time frame
Secondary endpoints are adverse reactions: uterine cramps and vaginal bleeding.	—

Contacts

Public ContactM. Dhont

Universitair Ziekenhuis Gent, Vrouwenziekten, De Pintelaan 185

Marc.Dhont@Ugent.be+32 92403796

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)