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Meta-Analysis
. 2020 Oct 15;10(10):CD003718.
doi: 10.1002/14651858.CD003718.pub5.

Tubal flushing for subfertility

Rui Wang  1 , Andrew Watson  2 , Neil Johnson  3 , Karen Cheung  4 , Cheryl Fitzgerald  5 , Ben Willem J Mol  1 , Lamiya Mohiyiddeen  5
Affiliations
Meta-Analysis

Tubal flushing for subfertility

Rui Wang et al. Cochrane Database Syst Rev. .

Abstract

Background: Establishing the subgroup analysis of the fallopian tubes (tubes) is a commonly undertaken diagnostic investigation for women with subfertility. This is usually achieved by flushing contrast medium through the tubes and visualising patency on radiographs, ultrasonography or laparoscopy. Many women were noted to conceive in the first three to six months after tubal flushing, raising the possibility that tubal flushing could also be a treatment for infertility. There has been debate about which contrast medium should be used (water-soluble or oil-soluble media) as this may influence pregnancy rates. An important adverse event during tubal flushing is intravasation (backflow of contrast medium into the blood or lymphatic vessels),which could lead to embolism although it is asymptomatic in most cases.

Objectives: To evaluate the effectiveness and safety of tubal flushing with oil-soluble contrast media (OSCM) and water-soluble contrast media (WSCM) on subsequent fertility outcomes in women with subfertility.

Search methods: We searched the Cochrane Gynaecology and Fertility Group Specialised Register of controlled trials, MEDLINE, Embase, CENTRAL, PsycINFO, reference lists of identified articles and trial registries. The most recent search was conducted in April 2020.

Selection criteria: Randomised controlled trials (RCTs) comparing tubal flushing with OSCM, WSCM with each other or with no treatment, in women with subfertility.

Data collection and analysis: Two review authors independently selected the trials, assessed risk of bias and extracted data. We contacted study authors for additional information. The overall quality of the evidence was assessed using GRADE methods.

Main results: Fifteen trials involving 3864 women were included in this systematic review. Overall, the quality of evidence varied from very low to moderate: the main limitations were risk of bias, heterogeneity and imprecision. OSCM versus no treatment Four studies (506 women) were included in this comparison. Tubal flushing with OSCM may increase the odds of live birth (odds ratio (OR) 3.27, 95% confidence interval (CI) 1.57 to 6.85, 3 RCTs, 204 women, I2 = 0, low-quality evidence). This suggests that if the chance of live birth following no treatment is assumed to be 11%, the chance following tubal flushing with OSCM would be between 16% and 46%. Tubal flushing with OSCM may increase in the odds of clinical pregnancy (OR 3.54, 95% CI 2.08 to 6.02, 4 RCTs, 506 women, I2 = 18%, low-quality evidence). This suggests that if the chance of clinical pregnancy following no treatment is assumed to be 9%, the chance following tubal flushing with OSCM would be between 17% and 37%. No study measured intravasation or other adverse events such as infection, haemorrhage and congenital abnormalities. WSCM versus no treatment Only one study (334 women) was included in this comparison. We are uncertain whether tubal flushing with WSCM increase live birth compared to no treatment (OR 1.13, 95% CI 0.67 to 1.91, 1 RCT, 334 women, low-quality evidence). This suggests that if the chance of live birth following no treatment is assumed to be 21%, the chance following tubal flushing with WSCM would be between 15% and 33%. We are uncertain whether tubal flushing with WSCM increases clinical pregnancy compared to no treatment (OR 1.14, 95% CI 0.71 to 1.84, 1 RCT, 334 women, low-quality evidence). This suggests that if the chance of clinical pregnancy following no treatment is assumed to be 27%, the chance following tubal flushing with WSCM would be between 29% and 40%. One case with pelvic infection was reported in the WSCM group and no case with infection in the no treatment group in a one study (334 women). Meta-analysis was not performed due to the rare events. No study measured intravasation or other adverse events such as infection, haemorrhage and congenital abnormalities. OSCM versus WSCM Six studies (2598 women) were included in this comparison. Three studies reported live birth, including two with higher live birth in the OSCM group (OR 1.64, 95% CI 1.27 to 2.11, 1119 women; OR 3.45, 95% CI 1.97 to 6.03, 398 women); and one with insufficient evidence of a difference between groups (OR 0.92, 95% CI 0.60 to 1.40, 533 women). Given the substantial heterogeneity observed (I2 = 86%), meta-analysis was not performed. Tubal flushing with OSCM probably increased in the odds of intravasation (asymptomatic) compared to tubal flushing with WSCM (OR 5.00, 95% CI 2.25 to 11.12, 4 RCTs, 1912 women, I2 = 0, moderate-quality evidence). This suggests that if the chance of intravasation following tubal flushing with WSCM is assumed to be 1%, the chance following tubal flushing with OSCM would be between 2% and 9%. Tubal flushing with OSCM may increase the odds of clinical pregnancy (OR 1.42, 95% CI 1.10 to 1.85, 6 RCTs, 2598 women, I2 = 41%, low-quality evidence). This suggests that if the chance of clinical pregnancy following tubal flushing with WSCM is assumed to be 26%, the chance following tubal flushing with OSCM would be between 28% and 39%. We are uncertain whether tubal flushing with OSCM decreases the odds of infection (OR 0.22, 95% CI 0.04 to 1.22, 2 RCTs, 662 women, I2 = 0, very low-quality evidence) or haemorrhage (OR 0.65, 95% CI 0.40 to 1.06, 2 RCTs, 662 women, I2 = 0, very low-quality evidence). Three neonates with congenital abnormalities were reported in the OSCM group while no congenital abnormality was reported in the WSCM group in one study (1119 women). No meta-analysis was performed due to the rare events.

Authors' conclusions: The evidence suggests that compared to no treatment, tubal flushing with OSCM may increase the chance of live birth and clinical pregnancy, while it is uncertain whether tubal flushing with WSCM improves those outcomes. Compared to tubal flushing with WSCM, OSCM may improve clinical pregnancy while meta-analysis was impossible for live birth due to heterogeneity. Evidence also suggests that OSCM is associated with an increased risk of asymptomatic intravasation. Overall, adverse events, especially long-term adverse events, are poorly reported across studies.

Trial registration: ClinicalTrials.gov NCT02433418 NCT03604549.

PubMed Disclaimer

Conflict of interest statement

NJ is involved in fertility and endometriosis research with the University of Auckland and the University of Adelaide that is funded by Guerbet, the manufacturer of Lipiodol; he has also been in receipt of research funding from Abb‐Vie and Myovant Sciences;he has private appointments with private medical practice groups called Auckland Gynaecology Group and Repromed Auckland (with both of whom he is a shareholder); he has undertaken paid consultancies for Guerbet, as well as Myovant Sciences, Vifor Pharma and Roche Diagnostics; he was an investigator on two included trials (Johnson 2004 and Johnson 2019).

BWJM is supported by an NHMRC Investigator grant (GNT1176437) and reports consultancy for ObsEva, Merck KGaA, iGenomix and Guerbet ending July 2020; BWJM receives research support from Guerbet through his institute; BWJM was an investigator on one included trial (Dreyer 2017).

AW was an investigator on one included trial (Nugent 2002).

NJ, BWM and AW took no part in selection and data extraction of the studies of which they are authors.

RW, KC, CF and LM have no conflicts of interest to declare.

Figures

1
1
Main potential mechanisms of tubal flushing on subsequent fertility outcomes. This figure illustrates the potential effects of tubal flushing on the Fallopian tubes, the endometrium and the peritoneum. (Developed by Rui Wang and reproduced here with permission)
2
2
Study flow diagram.
3
3
Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.
4
4
Methodological quality summary: review authors' judgements about each methodological quality item for each included study.
5
5
Forest plot of comparison: 1 OSCM versus No treatment, outcome: 1.1 Live birth.
6
6
Forest plot of comparison: 1 OSCM versus No treatment, outcome: 1.3 Clinical Pregnancy.
7
7
Forest plot of comparison: 2 WSCM versus No treatment, outcome: 2.1 Live birth.
8
8
Forest plot of comparison: 3 OSCM versus WSCM, outcome: 3.1 Live birth.
9
9
Forest plot of comparison: 3 OSCM versus WSCM, outcome: 3.3 Intravasation.
10
10
Forest plot of comparison: 3 OSCM versus WSCM, outcome: 3.4 Clinical pregnancy.
1.1
1.1. Analysis
Comparison 1: OSCM versus No treatment, Outcome 1: Live birth
1.2
1.2. Analysis
Comparison 1: OSCM versus No treatment, Outcome 2: Intravasation
1.3
1.3. Analysis
Comparison 1: OSCM versus No treatment, Outcome 3: Clinical Pregnancy
1.4
1.4. Analysis
Comparison 1: OSCM versus No treatment, Outcome 4: Miscarriage per woman
1.5
1.5. Analysis
Comparison 1: OSCM versus No treatment, Outcome 5: Miscarriage per pregnancy
1.6
1.6. Analysis
Comparison 1: OSCM versus No treatment, Outcome 6: Ectopic pregnancy per woman
1.7
1.7. Analysis
Comparison 1: OSCM versus No treatment, Outcome 7: Procedural pain
1.8
1.8. Analysis
Comparison 1: OSCM versus No treatment, Outcome 8: Infection
1.9
1.9. Analysis
Comparison 1: OSCM versus No treatment, Outcome 9: Haemorrhage
1.10
1.10. Analysis
Comparison 1: OSCM versus No treatment, Outcome 10: Long‐term complications
2.1
2.1. Analysis
Comparison 2: WSCM versus No treatment, Outcome 1: Live birth
2.2
2.2. Analysis
Comparison 2: WSCM versus No treatment, Outcome 2: Intravasation
2.3
2.3. Analysis
Comparison 2: WSCM versus No treatment, Outcome 3: Clinical Pregnancy
2.4
2.4. Analysis
Comparison 2: WSCM versus No treatment, Outcome 4: Miscarriage per woman
2.5
2.5. Analysis
Comparison 2: WSCM versus No treatment, Outcome 5: Miscarriage per pregnancy
2.6
2.6. Analysis
Comparison 2: WSCM versus No treatment, Outcome 6: Ectopic pregnancy per woman
2.7
2.7. Analysis
Comparison 2: WSCM versus No treatment, Outcome 7: Procedural pain
2.8
2.8. Analysis
Comparison 2: WSCM versus No treatment, Outcome 8: Infection
2.9
2.9. Analysis
Comparison 2: WSCM versus No treatment, Outcome 9: Haemorrhage
2.10
2.10. Analysis
Comparison 2: WSCM versus No treatment, Outcome 10: Long‐term complications
3.1
3.1. Analysis
Comparison 3: OSCM versus WSCM, Outcome 1: Live birth
3.2
3.2. Analysis
Comparison 3: OSCM versus WSCM, Outcome 2: Live birth (subgroup analysis)
3.3
3.3. Analysis
Comparison 3: OSCM versus WSCM, Outcome 3: Intravasation
3.4
3.4. Analysis
Comparison 3: OSCM versus WSCM, Outcome 4: Clinical pregnancy
3.5
3.5. Analysis
Comparison 3: OSCM versus WSCM, Outcome 5: Miscarriage per woman
3.6
3.6. Analysis
Comparison 3: OSCM versus WSCM, Outcome 6: Miscarriage per pregnancy
3.7
3.7. Analysis
Comparison 3: OSCM versus WSCM, Outcome 7: Ectopic pregnancy per woman
3.8
3.8. Analysis
Comparison 3: OSCM versus WSCM, Outcome 8: Procedural pain (dichotomous variable)
3.9
3.9. Analysis
Comparison 3: OSCM versus WSCM, Outcome 9: Procedural pain (continuous variable)
3.10
3.10. Analysis
Comparison 3: OSCM versus WSCM, Outcome 10: Infection
3.11
3.11. Analysis
Comparison 3: OSCM versus WSCM, Outcome 11: Haemorrhage
3.12
3.12. Analysis
Comparison 3: OSCM versus WSCM, Outcome 12: Long‐term complications
4.1
4.1. Analysis
Comparison 4: OSCM + WSCM versus WSCM, Outcome 1: Live birth
4.2
4.2. Analysis
Comparison 4: OSCM + WSCM versus WSCM, Outcome 2: Intravasation
4.3
4.3. Analysis
Comparison 4: OSCM + WSCM versus WSCM, Outcome 3: Clinical Pregnancy
4.4
4.4. Analysis
Comparison 4: OSCM + WSCM versus WSCM, Outcome 4: Miscarriage per woman
4.5
4.5. Analysis
Comparison 4: OSCM + WSCM versus WSCM, Outcome 5: Miscarriage per pregnancy
4.6
4.6. Analysis
Comparison 4: OSCM + WSCM versus WSCM, Outcome 6: Ectopic pregnancy per woman
4.7
4.7. Analysis
Comparison 4: OSCM + WSCM versus WSCM, Outcome 7: Procedural pain
4.8
4.8. Analysis
Comparison 4: OSCM + WSCM versus WSCM, Outcome 8: Infection
4.9
4.9. Analysis
Comparison 4: OSCM + WSCM versus WSCM, Outcome 9: Haemorrhage
4.10
4.10. Analysis
Comparison 4: OSCM + WSCM versus WSCM, Outcome 10: Long‐term complications
See this image and copyright information in PMC

Update of

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