Clinical Trial: Preovulatory Uterine Flushing With Saline as a Treatment for Unexplained Infertility

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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 Summary: 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.
Sponsor: Centre Hospitalier Universitaire de Québec, CHU de Québec

Current Primary Outcome: Proportion of participants with a live birth resulting from one cycle of treatment [ Time Frame: 10 months after randomisation ]

Proportion of participants with a live birth resulting from one cycle of treatment based on questionnaire and medical data.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Proportion of participants with a pregnancy resulting from one cycle of treatment [ Time Frame: One month after randomisation ]
    Proportion of participants with a positive urinary or serum pregnancy test, gestational sac on ultrasound or histological evidence of trophoblastic tissue resulting from one cycle of treatment based on questionnaire and medical data.
  • Adverse effects [ Time Frame: One month after randomisation ]
    Number of participants with treatment-related pain, vagal symptoms, nausea, vomiting, temperature, pelvic infection
  • Proportion of participants who find the intervention acceptable [ Time Frame: One month after randomisation ]
    Proportion of participants that would be willing to receive the intervention for a second time and find the intervention acceptable.


Original Secondary Outcome: Same as current

Information By: Centre Hospitalier Universitaire de Québec, CHU de Québec

Dates:
Date Received: August 26, 2015
Date Started: August 2015
Date Completion: August 2018
Last Updated: March 2, 2017
Last Verified: March 2017