The purpose of this study is to determine whether preovulatory uterine flushing with physiological saline is effective in the treatment of unexplained infertility.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
192
Detecting the luteinizing hormone surge using test sticks in a urine sample
Injection of 20 millilitres of physiological saline by an intra-uterine catheter the day of the luteinizing hormone surge
Injection of 10 millilitres of physiological saline intravaginally the day of the luteinizing hormone surge
Centre Hospitalier Universitaire de Quebec
Québec, Canada
Proportion of participants with a live birth resulting from one cycle of treatment
Proportion of participants with a live birth resulting from one cycle of treatment based on questionnaire and medical data.
Time frame: 10 months after randomisation
Proportion of participants with a pregnancy resulting from one cycle of treatment
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.
Time frame: One month after randomisation
Adverse effects
Number of participants with treatment-related pain, vagal symptoms, nausea, vomiting, temperature, pelvic infection
Time frame: One month after randomisation
Proportion of participants who find the intervention acceptable
Proportion of participants that would be willing to receive the intervention for a second time and find the intervention acceptable.
Time frame: One month after randomisation
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Sexual intercourse on the day of the intervention and the following day