Preovulatory Uterine Flushing With Saline as a Treatment for Unexplained Infertility

Not Applicable

Active, not recruiting

• Conditions: Unexplained Infertility; Infertility
• Interventions: Behavioral: Detection of ovulation; Procedure: Uterine flushing; Procedure: Vaginal flushing; Behavioral: Sexual intercourse

• Registration Number: NCT02539290
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2015-08-26
• Study First Submitted QC: 2015-08-31
• Study First Posted: 2015-09-03
• Study Start: 2015-12-30
• Primary Completion: 2024-09-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-10
• Last Update Posted: 2025-01-13
• Study Completion: 2025-03-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 192

Inclusion Criteria

• 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.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Uterine flushing	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
Uterine flushing	Sexual intercourse	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
Vaginal flushing	Sexual intercourse	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
Uterine flushing	Detection of ovulation	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
Vaginal flushing	Detection of ovulation	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
Vaginal flushing	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

Primary Outcome Measures

Name	Time	Method
Proportion of participants with a live birth resulting from one cycle of treatment	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

Name	Time	Method
Adverse effects	One month after randomisation	Number of participants with treatment-related pain, vagal symptoms, nausea, vomiting, temperature, pelvic infection
Proportion of participants with a pregnancy resulting from one cycle of treatment	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.
Proportion of participants who find the intervention acceptable	One month after randomisation	Proportion of participants that would be willing to receive the intervention for a second time and find the intervention acceptable.

Trial Locations

Locations (1)

Centre Hospitalier Universitaire de Quebec; 🇨🇦 Quebec, Canada