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Preovulatory Uterine Flushing With Saline as a Treatment for Unexplained Infertility

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ClinicalTrials.gov Identifier: NCT02539290
Recruitment Status : Recruiting
First Posted : September 3, 2015
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
CHU de Quebec-Universite Laval

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
Unexplained Infertility Infertility Behavioral: Detection of ovulation Procedure: Uterine flushing Procedure: Vaginal flushing Behavioral: Sexual intercourse Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Preovulatory Uterine Flushing With Saline as a Treatment for Unexplained Infertility: A Randomised Controlled Trial Protocol
Study Start Date : August 2015
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

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 Name: Tubal flushing

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




Primary Outcome Measures :
  1. Proportion of participants with a live birth resulting from one cycle of treatment [ Time Frame: 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 :
  1. Proportion of participants with a pregnancy resulting from one cycle of treatment [ Time Frame: 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.

  2. Adverse effects [ Time Frame: One month after randomisation ]
    Number of participants with treatment-related pain, vagal symptoms, nausea, vomiting, temperature, pelvic infection

  3. Proportion of participants who find the intervention acceptable [ Time Frame: One month after randomisation ]
    Proportion of participants that would be willing to receive the intervention for a second time and find the intervention acceptable.



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Ages Eligible for Study:   18 Years to 37 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02539290


Contacts
Contact: Sarah Maheux, MD-MSc 1-418-525-4444 sarah.maheux.lacroix@gmail.com
Contact: Sylvie Dodin, MD-MSc 1-418-656-2131 sylvie.dodin@fmed.ulaval.ca

Locations
Canada
Centre Hospitalier Universitaire de Quebec Recruiting
Quebec, Canada, G1V 4G2
Contact: Sarah Maheux-Lacroix, MD-MSc    1-418-525-4444    sarah.maheux.lacroix@gmail.com   
Contact: Sylvie Dodin, MD-MSc    1-418-656-2131    sylvie.dodin@fmed.ulaval.ca   
Sponsors and Collaborators
CHU de Quebec-Universite Laval
Investigators
Study Director: Sylvie Dodin, MD-MSc Centre Hospitalier Universitaire de Quebec

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: CHU de Quebec-Universite Laval
ClinicalTrials.gov Identifier: NCT02539290     History of Changes
Other Study ID Numbers: 2015-1146
First Posted: September 3, 2015    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 2017

Keywords provided by CHU de Quebec-Universite Laval:
Unexplained infertility
Infertility
Tubal flushing
Uterine flushing
Live birth
Pregnancy
Randomized controlled trial
Saline
Physiological saline

Additional relevant MeSH terms:
Infertility
Flushing
Genital Diseases, Male
Genital Diseases, Female
Signs and Symptoms
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs