Preovulatory Uterine Flushing With Saline as a Treatment for Unexplained Infertility

March 2, 2017 updated by: CHU de Quebec-Universite Laval

Preovulatory Uterine Flushing With Saline as a Treatment for Unexplained Infertility: A Randomised Controlled Trial Protocol

The purpose of this study is to determine whether preovulatory uterine flushing with physiological saline is effective in the treatment of unexplained infertility.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

192

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 37 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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:
  • 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
Behavioral: Sexual intercourse
Sexual intercourse within 12 hours after intervention
Procedure: Vaginal flushing
Injection of 10 millilitres of physiological saline intravaginally the day of the luteinizing hormone surge

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 months after randomisation

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHU de Quebec-Universite Laval

Investigators

  • Study Director: Sylvie Dodin, MD-MSc, Centre Hospitalier Universitaire de Quebec

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Anticipated)

August 1, 2018

Study Completion (Anticipated)

August 1, 2018

Study Registration Dates

First Submitted

August 26, 2015

First Submitted That Met QC Criteria

August 31, 2015

First Posted (Estimate)

September 3, 2015

Study Record Updates

Last Update Posted (Actual)

March 3, 2017

Last Update Submitted That Met QC Criteria

March 2, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-1146

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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