Review question
Cochrane authors reviewed the evidence about the effect on fertility with the surgical removal of fibroids in infertile women.
Background
Fibroids are the most common benign tumours of the female genital tract and commonly affect women of reproductive age. Fibroids occur in different parts of the womb and can vary in size and shape. Fibroids can lead to a variety of symptoms including heavy periods, pain, difficulty to conceive, or problems with pregnancy such as miscarriage and premature labour. In women wishing to preserve their fertility, it is possible to remove the fibroid while preserving the womb, an operation known as myomectomy. This procedure can be performed by laparotomy (open abdominal surgery), laparoscopic surgery (a key-hole through the abdomen) or hysteroscopic surgery (a key-hole through the neck of the womb) depending on the site and size of the fibroid. This review aimed to answer two questions. Firstly, whether myomectomy led to an improvement in fertility; and secondly, if the procedure is beneficial, what is the ideal surgical approach?
Study characteristics
This review included four studies with 442 participants. One study compared myomectomy to no treatment. The remaining three studies compared different surgical methods of performing a myomectomy. The evidence is current to February 2019.
Key results
One study examined the effect of myomectomy compared to no treatment. Results found insufficient evidence to determine a difference between treatment options for clinical pregnancy rate or miscarriage rate. This study did not report on live birth, preterm delivery, ongoing pregnancy or caesarean section rate. Regarding the best surgical approach, three studies were identified. Two studies compared myomectomy by mini-laparotomy or laparotomy to laparoscopic myomectomy and found insufficient evidence to determine a difference for live birth, preterm delivery, clinical pregnancy, miscarriage, caesarean section and ongoing pregnancy rate. The third study compared use of different surgical equipment during hysteroscopic myomectomy and found insufficient evidence to determine a difference for live birth/ongoing pregnancy rate, clinical pregnancy rate and miscarriage rate. This study did not report on caesarean section or preterm delivery rate. It is clear that more studies are needed before a consensus can be reached on the role of myomectomy for infertility.
Quality of evidence
The evidence was very low quality. There are some concerns regarding how the data were analysed and therefore the evidence cannot be considered to be conclusive until further studies are available.
There is limited evidence to determine the role of myomectomy for infertility in women with fibroids as only one trial compared myomectomy with no myomectomy. If the decision is made to have a myomectomy, the current evidence does not indicate a superior method (laparoscopy, laparotomy or different electrosurgical systems) to improve rates of live birth, preterm delivery, clinical pregnancy, ongoing pregnancy, miscarriage, or caesarean section. Furthermore, the existing evidence needs to be viewed with caution due to the small number of events, minimal number of studies and very low-quality evidence.
Fibroids are the most common benign tumours of the female genital tract and are associated with numerous clinical problems including a possible negative impact on fertility. In women requesting preservation of fertility, fibroids can be surgically removed (myomectomy) by laparotomy, laparoscopically or hysteroscopically depending on the size, site and type of fibroid. Myomectomy is however a procedure that is not without risk and can result in serious complications. It is therefore essential to determine whether such a procedure can result in an improvement in fertility and, if so, to then determine the ideal surgical approach.
To examine the effect of myomectomy on fertility outcomes and to compare different surgical approaches.
We searched the Cochrane Gynaecology and Fertility Group (CGFG) Specialised Register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, Epistemonikos database, World Health Organization (WHO) International Clinical Trials Registry Platform search portal, Database of Abstracts of Reviews of Effects (DARE), LILACS, conference abstracts on the ISI Web of Knowledge, OpenSigle for grey literature from Europe, and reference list of relevant papers. The final search was in February 2019.
Randomised controlled trials (RCTs) examining the effect of myomectomy compared to no intervention or where different surgical approaches are compared regarding the effect on fertility outcomes in a group of infertile women suffering from uterine fibroids.
Data collection and analysis were conducted in accordance with the procedure suggested in the Cochrane Handbook for Systematic Reviews of Interventions.
This review included four RCTs with 442 participants. The evidence was very low-quality with the main limitations being due to serious imprecision, inconsistency and indirectness.
Myomectomy versus no intervention
One study examined the effect of myomectomy compared to no intervention on reproductive outcomes. We are uncertain whether myomectomy improves clinical pregnancy rate for intramural (odds ratio (OR) 1.88, 95% confidence interval (CI) 0.57 to 6.14; 45 participants; one study; very low-quality evidence), submucous (OR 2.04, 95% CI 0.62 to 6.66; 52 participants; one study; very low-quality evidence), intramural/subserous (OR 2.00, 95% CI 0.40 to 10.09; 31 participants; one study; very low-quality evidence) or intramural/submucous fibroids (OR 3.24, 95% CI 0.72 to 14.57; 42 participants; one study; very low-quality evidence). Similarly, we are uncertain whether myomectomy reduces miscarriage rate for intramural fibroids (OR 1.33, 95% CI 0.26 to 6.78; 45 participants; one study; very low-quality evidence), submucous fibroids (OR 1.27, 95% CI 0.27 to 5.97; 52 participants; one study; very low-quality evidence), intramural/subserous fibroids (OR 0.80, 95% CI 0.10 to 6.54; 31 participants; one study; very low-quality evidence) or intramural/submucous fibroids (OR 2.00, 95% CI 0.32 to 12.33; 42 participants; one study; very low-quality evidence). This study did not report on live birth, preterm delivery, ongoing pregnancy or caesarean section rate.
Laparoscopic myomectomy versus myomectomy by laparotomy or mini-laparotomy
Two studies compared laparoscopic myomectomy to myomectomy at laparotomy or mini-laparotomy. We are uncertain whether laparoscopic myomectomy compared to laparotomy or mini-laparotomy improves live birth rate (OR 0.80, 95% CI 0.42 to 1.50; 177 participants; two studies; I2 = 0%; very low-quality evidence), preterm delivery rate (OR 0.70, 95% CI 0.11 to 4.29; participants = 177; two studies; I2 = 0%, very low-quality evidence), clinical pregnancy rate (OR 0.96, 95% CI 0.52 to 1.78; 177 participants; two studies; I2 = 0%, very low-quality evidence), ongoing pregnancy rate (OR 1.61, 95% CI 0.26 to 10.04; 115 participants; one study; very low-quality evidence), miscarriage rate (OR 1.25, 95% CI 0.40 to 3.89; participants = 177; two studies; I2 = 0%, very low-quality evidence), or caesarean section rate (OR 0.69, 95% CI 0.34 to 1.39; participants = 177; two studies; I2 = 21%, very low-quality evidence).
Monopolar resectoscope versus bipolar resectoscope
One study evaluated the use of two electrosurgical systems during hysteroscopic myomectomy. We are uncertain whether bipolar resectoscope use compared to monopolar resectoscope use improves live birth/ongoing pregnancy rate (OR 0.86, 95% CI 0.30 to 2.50; 68 participants; one study, very low-quality evidence), clinical pregnancy rate (OR 0.88, 95% CI 0.33 to 2.36; 68 participants; one study; very low-quality evidence), or miscarriage rate (OR 1.00, 95% CI 0.19 to 5.34; participants = 68; one study; very low-quality evidence). This study did not report on preterm delivery or caesarean section rate.