Infertility, Unexplained Infertility
Conditions
Keywords
Unexplained infertility, Infertility, Tubal flushing, Uterine flushing, Live birth, Pregnancy, Randomized controlled trial, Saline, Physiological saline
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.
Interventions
BEHAVIORALDetection of ovulation
Detecting the luteinizing hormone surge using test sticks in a urine sample
PROCEDUREUterine flushing
Injection of 20 millilitres of physiological saline by an intra-uterine catheter the day of the luteinizing hormone surge
PROCEDUREVaginal flushing
Injection of 10 millilitres of physiological saline intravaginally the day of the luteinizing hormone surge
BEHAVIORALSexual intercourse
Sexual intercourse on the day of the intervention and the following day
Sponsors
CHU de Quebec-Universite Laval
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 37 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with a live birth resulting from one cycle of treatment | 10 months after randomisation | Proportion of participants with a live birth resulting from one cycle of treatment based on questionnaire and medical data. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with a pregnancy resulting from one cycle of treatment | 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 | 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 | One month after randomisation | Proportion of participants that would be willing to receive the intervention for a second time and find the intervention acceptable. |
Countries
Canada
Outcome results
None listed