NCT02539290

Preovulatory Uterine Flushing With Saline as a Treatment for Unexplained Infertility

Preovulatory Uterine Flushing With Saline as a Treatment for Unexplained Infertility: A Randomised Controlled Trial Protocol

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 192 (estimated)
• Sponsor: CHU de Quebec-Universite Laval · Academic / Other
• Sex: Female
• Age: 18 Years – 37 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether preovulatory uterine flushing with physiological saline is effective in the treatment of unexplained infertility.

Detailed description

In vitro fertilisation is the only current reasonable treatment for unexplained infertility. Uterine flushing, associated with a five-fold increase in pregnancy when performed preovulatory, has been proposed as a new alternative. This treatment could flush out debris or alter inflammatory factors preventing fertilisation and implantation. The objective of this study is to assess the efficacy of pre-ovulatory uterine flushing with physiological saline for the treatment of unexplained infertility. This study is a randomised controlled trial based on consecutive women aged between 18 and 37 years consulting for unexplained infertility for at least one year. The day of their luteinizing hormone surge, 192 participants will be randomised in two equal groups to either receive 20 millilitres of physiological saline by an intra-uterine catheter or 10 millilitres of saline intravaginally. Investigators will assess relative risk of live birth (primary outcome), as well as pregnancy over one cycle of treatment. Side effects, complications, and acceptability of the intervention will be reported.

Conditions

• Unexplained Infertility
• Infertility

Interventions

Type	Name	Description
BEHAVIORAL	Detection of ovulation	Detecting the luteinizing hormone surge using test sticks in a urine sample
PROCEDURE	Uterine flushing	Injection of 20 millilitres of physiological saline by an intra-uterine catheter the day of the luteinizing hormone surge
PROCEDURE	Vaginal flushing	Injection of 10 millilitres of physiological saline intravaginally the day of the luteinizing hormone surge
BEHAVIORAL	Sexual intercourse	Sexual intercourse on the day of the intervention and the following day

Timeline

• Start date: 2015-12-30
• Primary completion: 2024-09-30
• Completion: 2025-03-30
• First posted: 2015-09-03
• Last updated: 2025-01-13

Locations

1 site across 1 country: Canada