Preovulatory Uterine Flushing With Saline as a Treatment for Unexplained Infertility
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Uterine flushing Detection of ovulation, injection of 20 millilitres of physiological saline by an intra-uterine catheter the day of the luteinizing hormone surge, and sexual intercourse within 12 hours after intervention |
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
Other Names:
Behavioral: Sexual intercourse
Sexual intercourse within 12 hours after intervention
|
| Sham Comparator: Vaginal flushing Detection of ovulation, injection of 10 millilitres of physiological saline intravaginally the day of the luteinizing hormone surge, and sexual intercourse within 12 hours after intervention |
Behavioral: Detection of ovulation
Detecting the luteinizing hormone surge using test sticks in a urine sample
Procedure: Vaginal flushing
Injection of 10 millilitres of physiological saline intravaginally the day of the luteinizing hormone surge
Behavioral: Sexual intercourse
Sexual intercourse within 12 hours after intervention
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Primary or secondary infertility ≥12 months.
-
Diagnosis of unexplained infertility ≤36 months:
-
Anti-Mullerian hormone ≥0.4 ng/mL and/or follicle-stimulating hormone ≤13 IU/L in early follicular phase;
-
regular cycle of 25-35 days,
-
positive ovulation tests, and/or
-
luteal phase serum progesterone ≥25mmol/L in a natural cycle;
-
normal semen analysis;
-
normal uterine cavity;
-
patent tubes.
-
Negative genitourinary test for gonorrhoea and chlamydia ≤12 months.
Exclusion Criteria:
-
Body mass index ≥35 kg/m2.
-
Ongoing pregnancy.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre Hospitalier Universitaire de Quebec | Quebec | Canada | G1V 4G2 |
Sponsors and Collaborators
- CHU de Quebec-Universite Laval
Investigators
- Study Director: Sylvie Dodin, MD-MSc, Centre Hospitalier Universitaire de Quebec
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2015-1146