Uterine Flushing for Unexplained Infertility

Not currently recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if flushing the uterus with a saltwater solution can help women with unexplained infertility become pregnant. The procedure occurs around ovulation, when an egg is released. Participants are divided into two groups: one receives the uterine flushing, while the other undergoes a vaginal flushing for comparison. Women who have been trying to conceive for over a year without success and have a regular cycle may be suitable candidates for this trial. As an unphased trial, participants contribute to groundbreaking research that could provide new insights into infertility treatments.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that uterine flushing is generally well-tolerated by women, with most not experiencing serious side effects. This procedure uses a small amount of saline (a saltwater solution) to rinse the uterus. Studies have found it to be simple and minimally invasive, suggesting it is unlikely to cause harm or discomfort. However, like any medical procedure, some individuals might feel mild discomfort. No major reports of harmful events have been linked to uterine flushing. Overall, past experiences indicate it appears safe. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about uterine flushing for unexplained infertility because it offers a novel approach compared to current treatments like medication and assisted reproductive technologies. Unlike these standard options, uterine flushing involves a simple procedure where physiological saline is injected directly into the uterus during the luteinizing hormone surge. This method could potentially enhance the conditions for conception without the need for more invasive or costly interventions. Additionally, the procedure is designed to coincide with natural ovulation, integrating seamlessly with the body's own reproductive cycle. By exploring this technique, researchers hope to discover a less invasive and more natural way to improve fertility outcomes.

What evidence suggests that uterine flushing might be an effective treatment for unexplained infertility?

Research has shown that uterine flushing, one of the treatments studied in this trial, might help treat unexplained infertility. In one study, women who underwent uterine flushing had a 34% chance of getting pregnant, compared to 26% for those who did not receive the treatment. This suggests that uterine flushing could clear blockages and reduce swelling in the uterus, facilitating pregnancy. Another study found that similar methods, such as flushing the fallopian tubes with an oil-based solution, also increased pregnancy and birth rates. These findings offer hope that uterine flushing could be a less invasive option compared to treatments like IVF (in vitro fertilization). Meanwhile, this trial will evaluate vaginal flushing as a sham comparator to assess the specific effects of uterine flushing. ^{2 3 6 7 8}

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11689596/

Efficacy of uterine flushing with human chorionic ... According to the previous trial [14], the clinical pregnancy rate was 34% and 26% in the intervention and control groups, respectively.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03461601

Uterine Flushing With Human Chorionic Gonadotrophin ... A prospective randomized study included 210 women with Unexplained infertility subjected to combined ovarian stimulation and Intrauterine insemination (IUI).

3. bmjopen.bmj.com bmjopen.bmj.com/content/6/1/e009897

Preovulatory uterine flushing with saline as a treatment for ... Preovulatory uterine flushing could reduce intrauterine debris and inflammatory factors preventing pregnancy and constitute an alternative to IVF. Our objective ...

4. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/full/10.1002/uog.20238

Effectiveness on fertility outcome of tubal flushing with different ... Tubal flushing using oil-based contrast medium probably increases clinical pregnancy rates within 6 months and may increase subsequent live-birth rates.

5. bmcwomenshealth.biomedcentral.com bmcwomenshealth.biomedcentral.com/articles/10.1186/s12905-023-02385-1

The effectiveness of immediate versus delayed tubal flushing ... In women with unexplained infertility, tubal flushing with oil-based contrast during hysterosalpingography leads to significantly more live births.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4716241/

Preovulatory uterine flushing with saline as a treatment for ... Uterine flushing is usually well tolerated by women and would constitute a simple, affordable and minimally invasive treatment for unexplained ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10164300/

The effectiveness of immediate versus delayed tubal flushing ... In women with unexplained infertility, tubal flushing with oil-based contrast during hysterosalpingography leads to significantly more live ...

8. imrpress.com imrpress.com/journal/CEOG/52/2/10.31083/CEOG24896/htm

Fertility Outcome after Tubal Flushing in Patients ... Intrauterine pregnancy (IUP) was documented in 48 cases. The cumulative IUP rate was 64.6% in the patients who received tubal flushing, and 54.7 ...