Preovulatory Uterine Flushing With Saline as a Treatment for Unexplained Infertility

Study Overview
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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.

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.

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

Conditions
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Unexplained Infertility, Infertility

Intervention / Treatment
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* Behavioral: Detection of ovulation
* Procedure: Uterine flushing
* Procedure: Vaginal flushing
* Behavioral: Sexual intercourse


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 37 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Uterine flushing<br>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<br>* Detecting the luteinizing hormone surge using test sticks in a urine sample<br>Procedure: Uterine flushing<br>* Injection of 20 millilitres of physiological saline by an intra-uterine catheter the day of the luteinizing hormone surge<br>* Other names: Tubal flushing;Behavioral: Sexual intercourse<br>* Sexual intercourse within 12 hours after intervention<br>|
| Sham Comparator: Vaginal flushing<br>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<br>* Detecting the luteinizing hormone surge using test sticks in a urine sample<br>Procedure: Vaginal flushing<br>* Injection of 10 millilitres of physiological saline intravaginally the day of the luteinizing hormone surge<br>Behavioral: Sexual intercourse<br>* Sexual intercourse within 12 hours after intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with a pregnancy resulting from one cycle of treatment | 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 | 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 | Proportion of participants that would be willing to receive the intervention for a second time and find the intervention acceptable. | One month after randomisation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Unexplained infertility, Infertility, Tubal flushing, Uterine flushing, Live birth, Pregnancy, Randomized controlled trial, Saline, Physiological saline