Clinical trial NCT02539290: Preovulatory Uterine Flushing With Saline as a Treatment for Unexplained Infertility
Official title: Preovulatory Uterine Flushing With Saline as a Treatment for Unexplained Infertility: A Randomised Controlled Trial Protocol
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Unexplained Infertility
Infertility
Keywords: Unexplained infertility
Infertility
Tubal flushing
Uterine flushing
Live birth
Pregnancy
Randomized controlled trial
Saline
Physiological saline
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
First posted: 2015-09-03
Enrollment: 192
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

* Primary or secondary infertility ≥12 months.
* Diagnosis of unexplained infertility ≤24 months:

  * Anti-Mullerian hormone ≥0.4 ng/mL and/or follicle-stimulating hormone ≤13 IU/L in early follicular phase;
  * regular cycle of 21-35 days,
  * positive ovulation tests, and/or
  * luteal phase serum progesterone ≥25mmol/L in a natural cycle;
  * semen analysis with total motile sperm count ≥ 5 million;
  * normal uterine cavity;
  * patent tubes.
* Negative genitourinary test for gonorrhoea and chlamydia ≤12 months.

Exclusion Criteria:

* Body mass index ≥35 kg/m2.
* Ongoing pregnancy.

Primary outcomes:
measure: Proportion of participants with a live birth resulting from one cycle of treatment
timeFrame: 10 months after randomisation
Secondary outcomes:
measure: Proportion of participants with a pregnancy resulting from one cycle of treatment
timeFrame: One month after randomisation
measure: Adverse effects
timeFrame: One month after randomisation
measure: Proportion of participants who find the intervention acceptable
timeFrame: One month after randomisation
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: Centre Hospitalier Universitaire de Quebec
Study officials:
affiliation: Centre Hospitalier Universitaire de Quebec
name: Sylvie Dodin, MD-MSc
role: STUDY_DIRECTOR
References:
citation: Maheux-Lacroix S, Dodin S, Moore L, Bujold E, Lefebvre J, Bergeron ME. Preovulatory uterine flushing with saline as a treatment for unexplained infertility: a randomised controlled trial protocol. BMJ Open. 2016 Jan 6;6(1):e009897. doi: 10.1136/bmjopen-2015-009897.