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Original articles

Laparoscopic assessment of infertile women with normal hysterosalpingogram

Salama, Ahmed H.a; Hassan, Sabry S.a; Abo El Maged, Abd El Hamidb

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Evidence Based Women's Health Journal: August 2014 - Volume 4 - Issue 3 - p 122-126
doi: 10.1097/01.EBX.0000435392.67105.c8
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Abstract

Introduction

Unexplained infertility has no standard workup. Findings depend on the quantity, quality, and interpretation of investigations. The more examinations performed, the more likely that the pathology will be found, but this also increases the invasiveness and iatrogenicity 1. The American Society of Reproductive Medicine (ASRM) described the optimal assessment of infertile couples, proposing careful assessment of history and physical examination. Subsequent evaluations should provide evidence of ovulation (basal body temperature or midluteal-phase serum progesterone), uterine integrity (ultrasound), adequate sperm production (semen analysis), and patency of the fallopian tubes [nonsystematic hysterosalpingogram (HSG)] 1. As a relatively inexpensive outpatient procedure, HSG has many attributes of a first-line test for tubal patency 2. Although the HSG is considered safe, the procedure exposes patients to ionizing radiation and potentially allergenic contrast media. Lower abdominal pain and discomfort are commonly experienced by patients undergoing HSG. An HSG can induce or exacerbate pelvic inflammatory disease and uterine perforation, and postexamination hemorrhage is a possibility 3.

Diagnostic laparoscopy is generally accepted as the gold standard for the diagnosis of tubal pathology or other pelvic reproductive diseases, such as adhesions and endometriosis. Once identified, appropriate surgical treatment can be offered, enhancing the chance of spontaneous conception. Furthermore, in cases with a poor prognosis, laparoscopy could accelerate the commencement of IVF, bypassing unnecessary cycles of ovulatory stimulation with or without intrauterine insemination. Systematic laparoscopy exposes patients to the risks of general anesthesia, hazards of surgical complications, and adhesion formation. Fertility surgery is regularly bypassed by IVF to protect patients and reduce costs 4. The aim of the present work was to evaluate the role of laparoscopy in infertile women with normal HSG.

Patients and methods

The current prospective case series was conducted at Ain Shams University Maternity Hospital during the period from October 2010 till June 2011. Women with unexplained infertility included in the study were recruited from those attending infertility outpatient clinics at Ain Shams University Maternity Hospital. The purpose and procedures of the study were explained to all enrolled women and a written informed consent was obtained from each participant. The women included were subjected to a full assessment of history, gynecological examination, and routine infertility investigations, including semen analysis, hormonal profile, HSG, and transvaginal sonography. Unexplained infertility is defined as the inability to conceive for more than 1 year of defined time of unprotected intercourse with adequate coitus. The ASRM described the optimal assessment of infertile couples, proposing careful assessment of history and physical examination. Subsequent evaluations should provide evidence of ovulation (basal body temperature or midluteal-phase serum progesterone), uterine integrity (ultrasound), adequate sperm production (semen analysis), and patency of the fallopian tubes (nonsystematic HSG) 1. Normal HSG criteria were a normal uterine cavity, no evidence of tubal occlusion, normal fallopian tube contour, and free bilateral spillage of the contrast media into the peritoneal cavity. HSG was considered abnormal when unilateral or bilateral tubal obstruction was observed, abnormal tubal contour, or loculation of dye in the peritoneal cavity or peritubal area was found. Women with normal HSG were followed up for 6 months before performing any other investigation. Women underwent diagnostic laparoscopy when they failed to conceive within 6 months from performing HSG.

Laparoscopic procedure

All laparoscopies were performed under general anesthesia by the first author. An umbilical 10-mm port and two or three additional 5-mm operating ports were used. Tubal patency was checked by a methylene blue test. Laparoscopic procedures evaluated free dye spillage, pelvic adhesions, or endometriosis.

Abnormal findings at laparoscopy are classified as follows:

(a) General tubal pathology – cases with evidence of either unilateral or bilateral tubal obstruction and/or peritubal adhesions. (b) Tubal pathology considering tubal occlusion – cases with evidence of any form of tubal occlusion (one-sided or two-sided) or cases with evidence of only two-sided tubal occlusion. (c) Tubal pathology considering peritubal adhesions – those with evidence of peritubal adhesions. In patients with only one tube, the laparoscopy is interpreted as abnormal when the remaining tube shows obstruction and/or evidence of peritubal adhesions 5.

Normal laparoscopy was defined as an absence of the above pathologies. Tubal occlusion (unilateral or bilateral), dense adhesions, or severe endometriosis were considered as abnormal findings.

Statistical analysis

Data were analyzed using SPSS for Windows, version 13.0 (SPSS Inc., Chicago, Illinois, USA). Description of quantitative (numerical) variables was performed in the form of mean, SD, and range. Description of qualitative (categorical) data was performed in the form of number of cases and percent. Diagnostic accuracy was assessed using the following terms: sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy. The receiver operator characteristic curve was used to determine the best cut-off value of a certain variable. Sensitivity was defined as the ability of a test to detect positive cases and was calculated as true-positive cases/true-positive cases+false-negative cases. Specificity was defined as the ability of a test to exclude negative cases and was calculated as true-negative cases/true-negative cases+false-positive cases.

Positive predictive value is the percentage of true-positive cases to all positive (proportion of all individuals with positive tests who have the disease). Negative predictive value is the percentage of true-negative cases to all negative (the proportion of all individuals with negative tests who are nondiseased), whereas overall accuracy means true-negative+true-positive/all cases.

A difference with P value less than 0.05 was considered statistically significant.

All patients gave their formal consent. The protocol was approved the ethical committee of the Maternity Hospital Ain Shams University Maternity.

Results

A total of 50 pregnant women with unexplained infertility were included in the study. The mean age of the women was 26.1±4.0 years (range 1.5–9 years), and the mean duration of infertility was 3.6±1.7 years (range 1.5–9 years). According to laparoscopic findings, Table 1 shows the distribution of the results of the methylene blue test among the cases analyzed. Table 2 shows the findings of fallopian tubes among the study group. The findings of the ovary and ovarian fossa are shown in Table 3. Uterine, uterosacral ligaments, and Douglas pouch findings are shown in Tables 4, 5, and 6, respectively. The current study showed that 28 (56%) of the analyzed cases had normal tubes and ovaries, whereas seven (14%) had abnormal tubes, 19 (38%) had abnormal ovaries, and four (8%) had abnormal both ovaries and tubes. The professional diagnosis was changed in 32% of cases (Table 7).

T1-2
Table 1:
Distribution of the results of the methylene blue test among the cases analyzed (N=50)
T2-2
Table 2:
Findings of fallopian tubes among the cases analyzed (N=50)
T3-2
Table 3:
Findings of ovary and ovarian fossa among the cases analyzed (N=50)
T4-2
Table 4:
Findings of uterus among the cases analyzed (N=50)
T5-2
Table 5:
Findings of uterosacral ligament among the cases analyzed (N=50)
T6-2
Table 6:
Findings of Douglas pouch among the cases analyzed (N=50)
T7-2
Table 7:
Findings of ovaries and tubes among the cases analyzed (N=50)

Discussion

This study was carried out to verify the current practice of postponing laparoscopy after a normal HSG in infertile couples with no evident cause of infertility, aiming at reducing the need for interventional investigations, thus cutting down both the cost and the risk.

The results of the present study show that the probability of clinically relevant tubal disease in infertile patients with a normal HSG is low, and that laparoscopy does not seem justified in such cases; the sensitivity of HSG is 95% and specificity is 85% and laparoscopic findings indeed offer little additional diagnostic benefit that would alter the original treatment plan on the basis of the information initially provided by HSG. Our results were in agreement with the previous studies by Lavy and colleagues, who found that among 63 patients with a normal HSG or suspected unilateral tubal pathology, who were assigned to ovulation and intrauterine insemination, 60 patients were found to have laparoscopic findings that did not necessitate any change in the original treatment plan. In three patients (4.8%), abnormalities discovered at laparoscopy were of such an extent that a change in the original treatment regimen and referral to IVF was needed. Laparoscopy should be recommended in cases where bilateral tubal occlusion is suspected on HSG as patent tubes were found in 30% by laparoscopy 6.

Tsuji and colleagues reported that 57 infertile patients with normal HSG findings underwent diagnostic laparoscopy at Kinki University Hospital. In 46 (80.7%) of these patients, diagnostic laparoscopy indicated pathologic abnormalities. Specifically, endometriosis and peritubal and/or perifimbrial adhesions were found in 36 (63.2%) and five (8.8%) of the patients, respectively. In eight patients (14.0%), the management plan was switched to IVF because of severe tubal diseases 7.

The Practice Committee of the ASRM concluded that HSG is the standard first-line test to evaluate tubal patency 8. If HSG suggests patent tubes, tubal blockage is highly unlikely 9. However, in 60% of patients in whom HSG showed proximal tubal blockage, repeat HSG 1 month later showed tubal patency 10. HSG also has a therapeutic effect, with higher fecundity rates reported for several months after the procedure 11.

Haque concluded in his study that the overall result of the HSG was correlated with the findings of laparoscopy and laparotomy. The diagnostic reliability of HSG in terms of sensitivity was 81.25%, accuracy was 80.85%, and specificity was 80.00%. Therefore, HSG has a definite role to play in every infertility investigation, reducing the routine use of laparoscopy. This study established that HSG should be the first approach in the diagnosis of infertility that provides valuable information about both the uterine cavity and fallopian tubes at a low risk of hazards with ease of use 12 (Table 8).

T8-2
Table 8:
Change of diagnosis among the cases analyzed (N=50)

Other studies that compared HSG findings with laparoscopic findings found that laparoscopy identifies pelvic pathologies other than tubal occlusion in 33–68% of the patients with normal HSG, but whether these findings actually led to changes in the treatment protocol is reported only by Corson and colleagues, who found pathologies on laparoscopy in 68/100 patients with normal HSG. The authors concluded that laparoscopy for ‘normal’ infertile woman may be indicated in the workup depending on age-related fecundity, duration of infertility, and other factors that play a role in the decision-making process, although ‘laparoscopy really added little to alter the treatment plan’ 13.

Al-Badawi and colleagues found that 49% of the patients with normal HSG had pelvic pathologies, but 93% of them were described as ‘mild’. In cases where minimal or mild endometriosis or peritubal adhesions are identified by laparoscopy, neither surgery nor medical treatments have been proven to be of any benefit 14.

In a debate article discussing the usefulness of conventional methods of infertility evaluation, Balasch stressed the difficulties in pushing a woman with a normal HSG to undergo an invasive procedure such as laparoscopy. They reported that clinicians increasingly believe that turning to IVF is appropriate even without laparoscopy, and that this attitude toward laparoscopy represents a move from ‘diagnostic workup’ to a ‘prognosis-oriented approach’ in the investigation and treatment of infertile couples 15.

In contrast, according to the Canadian Collaborative Group on endometriosis, laparoscopic resection or ablation of minimal and mild endometriosis enhances fecundity in infertile women 15.

Conclusion

The role of diagnostic laparoscopy in patients with normal HSG should be reconsidered as the information obtained by laparoscopy in these patients would change the treatment protocol only in a small percentage.

Acknowledgements

Conflicts of interest

There are no conflicts of interest.

References

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Keywords:

HSG; infertility; laparoscopy; unexplained

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