Uterine Flushing for Unexplained Infertility

Overseen By Sarah Maheux, MD-MSc

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: CHU de Quebec-Universite Laval

Disqualifiers: Bmi ≥35, Ongoing pregnancy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 cycle

192 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing if washing the uterus with saltwater before ovulation can help women aged 18-37 who have unexplained infertility. The treatment might work by clearing out debris or changing inflammation in the uterus to make it easier to get pregnant.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is uterine flushing safe for humans?

Uterine flushing, particularly with oil-based contrast, is generally safe, but there is a risk of intravasation (backflow of the fluid into blood vessels), which could lead to embolism (blockage of a blood vessel), although this is usually without symptoms. ^{1 2 3 4 5}

How does uterine flushing differ from other treatments for unexplained infertility?

Uterine flushing with saline is unique because it aims to clear intrauterine debris and reduce inflammation, potentially improving fertility without the need for more invasive procedures like IVF. Unlike tubal flushing, which uses contrast media to check fallopian tube patency, uterine flushing specifically targets the uterine environment to enhance natural conception. ^{1 2 3 6 7}

What data supports the effectiveness of the treatment Uterine flushing, Vaginal flushing for unexplained infertility?

Research suggests that tubal flushing, a similar procedure, has been associated with increased pregnancy rates in the months following the treatment, indicating potential benefits for fertility. ^{1 2 6 8 9}

Who Is on the Research Team?

Sylvie Dodin, MD-MSc

Principal Investigator

Centre Hospitalier Universitaire de Quebec

Are You a Good Fit for This Trial?

This trial is for people with unexplained infertility who have tried to conceive for at least a year. They must have normal reproductive hormone levels, regular menstrual cycles, and no blockages in their fallopian tubes. Their partners should have normal semen analysis results, and they must not have any infections like gonorrhea or chlamydia.

Inclusion Criteria

Primary or secondary infertility ≥12 months

I meet all the fertility health criteria and have unexplained infertility for less than 2 years.

Exclusion Criteria

Body mass index ≥35 kg/m2

Ongoing pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive preovulatory uterine flushing with physiological saline or a sham comparator

1 cycle

1 visit (in-person)

Follow-up

Participants are monitored for pregnancy and live birth outcomes

10 months

What Are the Treatments Tested in This Trial?

Interventions

• Uterine flushing
• Vaginal flushing

Trial Overview The study is testing if washing the inside of the uterus with saline solution before ovulation can help couples with unexplained infertility get pregnant. It involves timed sexual intercourse and monitoring ovulation closely.

How Is the Trial Designed?

Group I: Uterine flushing Experimental Treatment 3 Interventions

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

Group II: Vaginal flushing Placebo Group 3 Interventions

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

Who Is Running the Clinical Trial?

CHU de Quebec-Universite Laval

Lead Sponsor

Trials

177

Recruited

110,000+

Citations

1. England pubmed.ncbi.nlm.nih.gov

Preovulatory uterine flushing with saline as a treatment for unexplained infertility: a randomised controlled trial protocol. [2019]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Follicular flushing in patients with poor ovarian response: a systematic review and meta-analysis. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Tubal flushing for subfertility. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Endometrial Factor in Unexplained Infertility and Recurrent Implantation Failure. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Tubal flushing for subfertility. [2022]

6. England pubmed.ncbi.nlm.nih.gov

What is the fertility-enhancing effect of tubal flushing? A hypothesis article. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Effectiveness on fertility outcome of tubal flushing with different contrast media: systematic review and network meta-analysis. [2020]

8. Netherlands pubmed.ncbi.nlm.nih.gov

How long does the fertility-enhancing effect of hysterosalpingography with oil-based contrast last? [2021]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Flushing the endometrium prior to the embryo transfer does not affect the pregnancy rate. [2019]