Objective
To evaluate the pregnancy and perinatal outcomes of ultrasound sclerotherapy with 98% ethanol on women with hydrosalpinx before in vitro fertilization and embryo transfer.
Study Design
A total of 339 women were divided into 4 groups. Group A without a recurrent hydrosalpinx after sclerotherapy (n = 123, 130 cycles), group B having a recurrence of hydrosalpinx after sclerotherapy (n = 34, 39 cycles), group C (n = 47, 50 cycles) with no prophylactic intervention for hydrosalpinx, whereas group D with nonhydrosalpinx tubal factor infertility was served as control group (n = 135, 145 cycles). Pulsatility index, resistance index, the ratio between peak systolic flow and lowest diastolic flow of the uterine arcuate artery on the day of human chorionic gonadotropin administration, and pregnancy and perinatal outcomes were assessed.
Results
Thirty-four women (21.7%) experienced hydrosalpinx recurrence after sclerotherapy. The rates of embryo implantation (8.8%), clinical pregnancy (16.0%), and live birth (10.0%) in group C were significantly lower than those in group A (26.4%, 43.1%, 33.8%), group B (24.5%, 38.5%, 28.2%), and group D (30.0%, 50.3%, 39.3%), respectively. The pulsatility index, resistance index, and the ratio between peak systolic flow and lowest diastolic flow of the uterine arcuate artery in group C were significantly higher than those in the other 3 groups. No significant differences in the rate of preterm birth, the rate of low birthweight newborns, and birth defects were found among the 4 groups.
Conclusion
Ultrasound sclerotherapy on women with hydrosalpinx could improve the outcomes of in vitro fertilization embryo transfer by improving the blood flow of the uterine arcuate artery. Interventional ultrasound sclerotherapy has no adverse effect on perinatal outcomes.
Several studies have demonstrated that the presence of hydrosalpinx may reduce pregnancy rates by 50% and double the spontaneous abortion rate by mechanically interfering with embryo implantation and/or reducing endometrial receptivity when in vitro fertilization and embryo transfer (IVF-ET) were performed. Although, there has been no coherent therapeutic method for hydrosalpinx before in vitro fertilization (IVF), Johnson reported that salpingectomy prior to IVF treatment could restore IVF-ET outcomes in patients with hydrosalpinx. However, the effect of salpingectomy on ovarian response remain controversial, some studies have shown that salpingectomy could have a negative effect on the ovarian blood flow and subsequently reduced ovarian response to gonadotrophin stimulation. Many simple methods for the treatment of hydrosalpinx (proximal tubal ligation, proximal tubal occlusion and ultrasound guided transvaginal aspiration of hydrosalpinx) have become popular options in practice. Aspiration of hydrosalpinx by transvaginal ultrasound-guided has obvious advantages of being simple, effective, less invasive, and cheap. The disadvantage was the high recurrence rate. As demonstrated in the previous report, ultrasound aspiration and sclerotherapy with 98% ethanol could improve the endometrial receptivity and outcomes of IVF, with no adverse effects on ovarian reserve and responsiveness during IVF. By expanding the sample size, the aim of the present study is to further evaluate the pregnancy and perinatal outcomes of ultrasound sclerotherapy with 98% ethanol on women with hydrosalpinx before IVF-ET.
Materials and Methods
A total of 339 patients with tubal factor infertility diagnosed by hysterosalpingogram and transvaginal ultrasound underwent 364 embryo transfer cycles at the Reproductive Medicine Center of 105 hospital of People’s Liberation Army (Hefei, China) from Jan. 2005 to Dec. 2011. Of these patients, 204 accompanied with hydrosalpinx, whereas the remaining 135 had nonhydrosalpinx. All the patients were divided into 4 groups: group A, 123 patients did not have a recurrent hydrosalpinx after sclerotherapy; group B, 34 patients with recurrence of hydrosalpinx after sclerotherapy; group C, 47 patients with no prophylactic intervention of hydrosalpinx; group D, the remaining 135 women with nonhydrosalpinx served as controls. In this nonrandomized study, the assignment of treatment modality for the patients was either by doctors’ suggestion or by patients’ choice. Group C are the patients with hydrosalpinx did not accept any treatments before IVF (such as salpingectomy, proximal tubal ligation, and interventional ultrasound sclerotherapy). The inclusion and exclusion criteria for all eligible cases and the procedure used for the sclerotherapy were similar to our previous report. The inclusion criteria were as follows: (1) female age ≤40 years; (2) baseline FSH <12 mIU/L and body mass index <28 kg/m 2 ; (3) endometriosis was merely excluded by the symptoms, the clinical examination and the ultrasound. The study was approved by the Ethics Committee of 105 hospital of People’s Liberation Army and all patients provided written informed consent.
The operation was peformed during days 7-12 of the menstrual cycle (day 1 being the first day of menstrual bleeding). Before the procedure, the patients were sedated with 50 mg of pethidine and 10 mg of diazepam injectio intramusculosa. The vulva, vagina, and puncture site were prepared and draped in a sterile manner. A transvaginal ultrasound examination was performed to identify the optimal site for insertion of the aspiration needle (usually at the middle of the maximal liquid plane), then hydrosalpinx was aspirated by 16-or 17-gauge needle (Cook, Queensland, Australia) until no further fluid could be obtained. The tube cavity was washed with gentamic in sulfate injection (80 mg) repeatedly, and infused with a volume of 98% ethanol equal to 1/2 volume of the aspirated fluid, and left in the tube cavity for 5-10 minutes, then removed. The process was performed on both sides if there were bilateral hydrosalpinges, using separate sterile needles on each side to avoid contamination between tubes. Patients were monitored for 1 hour after the procedure and prescribed oral cefradine 500 mg 3 times per day for 3 days. Ultrasound evaluation of the treatment efficacy was performed 2 weeks later and effectiveness of sclerotherapy was defined as without visible fluid in fallopian tube or remaining fluid less than 10% of original size before therapy. Recurrence was defined as the reappearance of a hydrosalpinx with remaining fluid more than 10% of original size before therapy.
After the sclerotherapy, patients received our standard IVF-ET protocols within 3 months, most of them received IVF in the subsequent menstrual cycle. Briefly, all patients were administered with a long luteal gonadotropin-releasing hormone agonist protocol, followed by controlled ovarian stimulation with follicle-stimulating hormone (FSH) in doses of 150-300 IU daily, which were adapted on the basis of serial ultrasonographic measurements of follicular growth and serum E2 evaluations. Ovulation was triggered with human chorionic gonadotrophin (hCG) when 5 leading follicles had reached 16 mm in diameter, then oocytes were recovered transvaginally under ultrasound-guidance 32-36 hours later. As our standard protocol, all oocytes were fertilized 4 to 6 hours after retrieval, and embryos were cultured individually until day 3. The best 2 or 3 embryos were transferred to the uterus using a soft catheter under ultrasound-guidance. The blood flow parameters of uterine arcuate artery such as PI, RI, and S/D on the day of hCG administration as well as the pregnancy and perinatal outcomes were recorded and compared among 4 groups.
Statistical comparisons were carried out by 1-way analysis of variance, χ 2 test, and Fisher exact test where appropriate. Statistics were performed with the SPSS 11.5 statistical package (SPSS Inc, Armonk, NY), significance was defined as a P value < .05.
Results
An area of hydrosalpinx fluid in 157 patients with interventional ultrasound sclerotherapy ranged from 19 × 12 mm to 106 × 42 mm. All patients tolerated the procedure well, with only mild abdominal cramping in several patients, and no infection or other complications were found. Thirty-four cases (21.7%) experienced hydrosalpinx recurrence after ultrasound sclerotherapy at the 2-week follow-up.
Table 1 summarizes the demographic data and the outcomes of IVF-ET. There were no differences in the age of women, duration of infertility, body mass index, FSH dosage and duration, number of eggs obtained, the rate of fertilization, and embryo quality among the 4 groups ( P > .05), but the rates of implantation (8.8%), clinical pregnancy (16.0%), and live birth (10.0%) in group C were significantly lower than those in group A (26.4%, 43.1%, 33.8%), group B (24.5%, 38.5%, 28.2%), and group D (30.0%, 50.3%, 39.3%), respectively ( P < .01), meanwhile the rates of abortion and ectopic pregnancy in group C showed no significant difference from the other 3 groups ( P < .05). There were no significant differences in pregnancy outcomes among group A, group B, and group D.
| Parameters | Group A | Group B | Group C | Group D | P value |
|---|---|---|---|---|---|
| No of patients | 123 | 34 | 47 | 135 | |
| No of IVF cycles | 130 | 39 | 50 | 145 | |
| Age of women, y a,e | 30.0 ± 3.6 | 30.4 ± 3.6 | 30.1 ± 3.7 | 30.3 ± 3.6 | NS |
| Body mass index, kg/m 2 a,e | 21.6 ± 1.6 | 21.3 ± 1.4 | 21.8 ± 1.9 | 21.4 ± 1.7 | NS |
| Infertility duration, y a,e | 6.0 ± 2.6 | 5.4 ± 2.6 | 5.4 ± 2.7 | 5.4 ± 2.6 | NS |
| Gn dosage, IU a,e | 2192.9 ± 573.8 | 2186.5 ± 590.5 | 2299.5 ± 491.1 | 2171.2 ± 509.2 | NS |
| Gn duration, d a,e | 11.2 ± 1.9 | 11.0 ± 1.9 | 11.7 ± 1.9 | 11.3 ± 1.6 | NS |
| No of eggs obtained a,e | 13.1 ± 6.1 | 12.2 ± 5.1 | 13.6 ± 4.9 | 14.2 ± 6.1 | NS |
| No of MII eggs a,e | 11.1 ± 5.1 | 10.6 ± 4.4 | 11.8 ± 4.0 | 12.1 ± 5.3 | NS |
| Fertility rate, % b,e | 82.0 | 78.5 | 78.3 | 81.4 | NS |
| Day 3 cleavage rate, % b,e | 94.0 | 94.2 | 91.6 | 93.4 | NS |
| Good quality embryo rate, % b,e | 65.7 | 65.4 | 63.9 | 62.3 | NS |
| No of transferred embyros a,e | 2.3 ± 0.5 | 2.4 ± 0.5 | 2.3 ± 0.4 | 2.3 ± 0.5 | NS |
| Implantation rate, n (%) b | 26.4 (79/299) | 24.5 (23/94) | 8.8 (10/113) d | 30.0 (100/333) | P ＜ .01 |
| Clinical pregnancy rate, n (%, per ET) b | 43.1 (56/130) | 38.5 (15/39) | 16.0 (8/50) d | 50.3 (73/145) | P ＜ .01 |
| Abortion rate, n (%) c,e | 14.3 (8/56) | 20.0 (3/15) | 25.0 (2/8) | 16.4 (12/73) | NS |
| Ectopic pregnancy rate, n (%) c,e | 7.1 (4/56) | 6.7 (1/15) | 12.5 (1/8) | 5.5 (4/73) | NS |
| Live birth rate, n (%, per ET) b | 33.8 (44/130) | 28.2 (11/39) | 10.0 (5/50) d | 39.3 (57/145) | P ＜ .01 |
a By 1-way analysis of variance
d Group C vs other 3 groups ( P < .01)
There were no statistically significant differences in the endometrial thickness on the day of hCG administration among the 4 groups. Transvaginal color Doppler examination on the uterine arcuate artery was performed in 364 IVF-ET cycles. It was shown that the blood flow impedance parameters of uterine arcuate artery such as pulsatility index, resistance index, and peak systolic velocity/end diastolic velocity in group C on the day of hCG administration were significantly higher than those in group A, group B, and group D ( P < .05), which showed no statistical differences among group A, group B, and group D ( P > .05) ( Table 2 ).
| Variables | Group A | Group B | Group C | Group D | P value |
|---|---|---|---|---|---|
| Endometrial thickness, mm a,b,e | 10.5 ± 1.7 | 10.7 ± 1.9 | 10.6 ± 1.8 | 10.5 ± 1.7 | NS |
| Uterine arcuate artery PI a,b | 0.92 ± 0.12 | 0.93 ± 0.12 | 0.99 ± 0.10 c | 0.92 ± 0.12 | P < .05 |
| Uterine arcuate artery RI a,b | 0.56 ± 0.04 | 0.57 ± 0.03 | 0.59 ± 0.03 d | 0.56 ± 0.04 | P < .01 |
| Uterine arcuate artery S/D a,b | 2.20 ± 0.19 | 2.21 ± 0.20 | 2.38 ± 0.25 d | 2.18 ± 0.20 | P < .01 |
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