Preovulatory Uterine Flushing With Saline as a Treatment for Unexplained Infertility

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-30

Study Completion Date

2025-03-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Unexplained Infertility Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Detection of ovulation

Intervention Type BEHAVIORAL

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

Uterine flushing

Intervention Type PROCEDURE

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

Sexual intercourse

Intervention Type BEHAVIORAL

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

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

Group Type SHAM_COMPARATOR

Detection of ovulation

Intervention Type BEHAVIORAL

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

Vaginal flushing

Intervention Type PROCEDURE

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

Sexual intercourse

Intervention Type BEHAVIORAL

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

Interventions

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Detection of ovulation

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

Intervention Type BEHAVIORAL

Uterine flushing

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

Intervention Type PROCEDURE

Vaginal flushing

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

Intervention Type PROCEDURE

Sexual intercourse

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Tubal flushing

Eligibility Criteria

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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.