NCT02539290

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
192

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 3, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

December 30, 2015

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2025

Completed
Last Updated

January 13, 2025

Status Verified

January 1, 2025

Enrollment Period

8.8 years

First QC Date

August 26, 2015

Last Update Submit

January 10, 2025

Conditions

Unexplained InfertilityInfertility

Keywords

Unexplained infertilityInfertilityTubal flushingUterine flushingLive birthPregnancyRandomized controlled trialSalinePhysiological saline

Outcome Measures

Primary Outcomes (1)

  • Proportion of participants with a live birth resulting from one cycle of treatment

    Proportion of participants with a live birth resulting from one cycle of treatment based on questionnaire and medical data.

    10 months after randomisation

Secondary Outcomes (3)

  • Proportion of participants with a pregnancy resulting from one cycle of treatment

    One month after randomisation

  • Adverse effects

    One month after randomisation

  • Proportion of participants who find the intervention acceptable

    One month after randomisation

Study Arms (2)

Uterine flushing

EXPERIMENTAL

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 ovulationProcedure: Uterine flushingBehavioral: Sexual intercourse

Vaginal flushing

SHAM COMPARATOR

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 ovulationProcedure: Vaginal flushingBehavioral: Sexual intercourse

Interventions

Detection of ovulationBEHAVIORAL

Detecting the luteinizing hormone surge using test sticks in a urine sample

Uterine flushingVaginal flushing
Uterine flushingPROCEDURE

Injection of 20 millilitres of physiological saline by an intra-uterine catheter the day of the luteinizing hormone surge

Also known as: Tubal flushing
Uterine flushing
Vaginal flushingPROCEDURE

Injection of 10 millilitres of physiological saline intravaginally the day of the luteinizing hormone surge

Vaginal flushing
Sexual intercourseBEHAVIORAL

Sexual intercourse on the day of the intervention and the following day

Uterine flushingVaginal flushing

Eligibility Criteria

Age18 Years - 37 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Primary or secondary infertility ≥12 months.
  • Diagnosis of unexplained infertility ≤24 months:
  • Anti-Mullerian hormone ≥0.4 ng/mL and/or follicle-stimulating hormone ≤13 IU/L in early follicular phase;
  • regular cycle of 21-35 days,
  • positive ovulation tests, and/or
  • luteal phase serum progesterone ≥25mmol/L in a natural cycle;
  • semen analysis with total motile sperm count ≥ 5 million;
  • normal uterine cavity;
  • patent tubes.
  • Negative genitourinary test for gonorrhoea and chlamydia ≤12 months.

You may not qualify if:

  • Body mass index ≥35 kg/m2.
  • Ongoing pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de Quebec

Québec, G1V 4G2, Canada

Location

Related Publications (1)

  • Maheux-Lacroix S, Dodin S, Moore L, Bujold E, Lefebvre J, Bergeron ME. Preovulatory uterine flushing with saline as a treatment for unexplained infertility: a randomised controlled trial protocol. BMJ Open. 2016 Jan 6;6(1):e009897. doi: 10.1136/bmjopen-2015-009897.

    PMID: 26739737DERIVED

MeSH Terms

Conditions

Infertility

Interventions

Sex

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Reproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Officials

  • Sylvie Dodin, MD-MSc

    Centre Hospitalier Universitaire de Quebec

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2015

First Posted

September 3, 2015

Study Start

December 30, 2015

Primary Completion

September 30, 2024

Study Completion

March 30, 2025

Last Updated

January 13, 2025

Record last verified: 2025-01

Locations

CA(1)