Nasal Oxcytocin During IUI

What Was Tested

The trial (not phased) is built around Oxytocin.

It had 1 arm (groups): Oxytocin (experimental).

Intranasal oxytocin during IUI.

The registry classes the interventions as drug.

More on the Plan

Between 2004 and 2007, 86 patients with primary or secondary infertility were enrolled in this prospective, randomized, double-blinded study in their tertiary-care infertility center.

A total of 132 homologous intrauterine insemination (IUI) cycles (mean: 1.5 cycles) was performed.

All patients gave informed consent.

Inclusion criteria for couples were idiopathic infertility, polycystic ovary syndrome (PCOS) and / or male subfertility (table 1).

Who Took Part

86 actual participants took part.

It was open to people of any sex aged from 18 years up to 43 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Inclusion criteria for couples were idiopathic infertility, polycystic ovary syndrome (PCOS) and / or male subfertility. Infections with Hepatitis B and C and HIV were excluded in all couples by negative serological tests. In all patients protective titers against rubella virus were confirmed.

The full record lists 5 inclusion and 2 exclusion criteria; among the exclusions: patients displaying signs or symptoms of anomalies such as uterine fusion defects, submucosal fibroids, active endometriosis or acute inflammation were excluded from the study.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Because people in this Oxytocin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Oxytocin group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Oxytocin.

It started in 2003-05 with completion listed for 2008-01.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Pregnancy rate (time frame: 1 month).

It also tracked 1 secondary outcome, for example Possible side effects: nasal mucosal irritation, headake, lower abdominal pain.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 86 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, all human trials.