Effectiveness of auto-crosslinked hyaluronic acid gel in the prevention of intrauterine adhesions after hysteroscopic surgery: a prospective, randomized, controlled study

BACKGROUND: A prospective, randomized, controlled study was performed to assess the efficacy of auto-crosslinked hyaluronic acid (ACP) gel to prevent the development of de-novo intrauterine adhesions following hysteroscopic surgery. METHODS: One hundred and thirty-two patients with a single surgically remediable intrauterine lesion (myomas, polyps and uterine septa, subgroups I-III) completed the study. Patients were randomized to two different groups: group A underwent hysteroscopic surgery plus intrauterine application of ACP gel (10 ml) while group B underwent hysteroscopic surgery alone (control group). The rate of adhesion formation and the adhesion score was calculated for each group and subgroup 3 months after surgery. RESULTS: Group A showed a significant reduction in the development of de-novo intrauterine adhesions at 3 months follow-up in comparison with the control group. Furthermore, the staging of adhesions showed a significant decrease in adhesion severity in patients treated with ACP gel. CONCLUSIONS: ACP gel significantly reduces the incidence and severity of de-novo formation of intrauterine adhesions after hysteroscopic surgery.     

Reproductive outcome following hysteroscopic management of intrauterine septum and adhesions

The reproductive outcome of women with repeated abortions orinfertility was assessed following treatment by operative hysteroscopyfor an intrauterine septum or adhesions. A prospective follow-upstudy (mean ± SD, 21.1 7plusmn; 10.3 months) of 47 patientswith an intrauterine septum (36 suffering from infertility and11 from recurrent abortions) and 36 patients with intrauterineadhesions (24 complaining of infertility and 12 of recurrentabortions) was performed. The pregnancy rate in infertile womenfollowing hysteroscopic resection of an intrauterine septumor adhesions was 53 and 48% respectively. The pregnancy wastagein women with recurrent abortions who underwent hysteroscopicresection of an intrauterine septum or adhesions decreased postoperativelyfrom 87.5 to 44.4% and from 86.5 to 42.8% respectively. Ourresults suggest that hysteroscopic resection of an intrauterineseptum or adhesions may benefit patients suffering from infertilityor recurrent pregnancy wastage.     

Reduction of postoperative adhesions with an auto-crosslinked hyaluronan gel in gynaecological laparoscopic surgery: a blinded, controlled, randomized, multicentre study

BACKGROUND: Following myomectomy, postoperative adhesions occur in many patients with adverse effects on fertility. This study investigated the applicability, safety and efficacy of an auto-crosslinked hyaluronan gel in preventing adhesion formation after laparoscopic myomectomy. METHODS: Fifty-two patients aged 22-42 years, undergoing surgery at four centres, were randomly allocated to receive either the gel or no adhesion prevention. The incidence and severity of postoperative adhesions were assessed laparoscopically after 12-14 weeks in a blinded, scored fashion. The primary efficacy variable was the presence/absence of postoperative adhesions at second-look. RESULTS: A nonsignificantly higher proportion of patients receiving the gel were free from adhesions (13 of 21; 62%) compared with control patients (9 of 22; 41%), with a statistically significant difference between the severity of uterine adhesions at baseline and at second-look (0.3 +/- 0.9 versus 0.8 +/- 1.0, P < 0.05). In subjects undergoing myomectomy without concomitant surgery, the proportion of adhesion-free patients was 8 of 12 (67%) and 4 of 11 (36%) (not significant) in the gel and control groups, respectively, with a significant difference in the mean severity scores (P < 0.05). In subjects without uterine adhesions before myomectomy, 12 of 18 (67%) and 8 of 20 (40%) patients in the gel and control groups, respectively were adhesion-free (not significant), with a significant difference in the severity of uterine adhesions (P = 0.05). CONCLUSIONS: Our results suggest that the auto-crosslinked hyaluronan gel may have a favourable safety profile and efficacious antiadhesive action following laparoscopic myomectomy.     

Experimental validation for the use of a film on the basis of modified hyaluronic acid for prevention of postoperative peritoneal adhesions

A film coating based on hyaluronic acid and 5-aminosalicylic acid was developed for the creation of anti-adhesion barrier. Application of the protective film in Wistar rats with modeled adhesion process in the abdominal cavity reduced the formation of peritoneal adhesions. __________ Translated from Byulleten’ Eksperimental’noi Biologii i Meditsiny, Vol. 144, No. 8, pp. 238–240, August, 2007     

Post-operative adhesions after laparoscopic electrosurgical treatment for polycystic ovarian syndrome with the application of Interceed to one ovary: a prospective randomized controlled study

In this prospective, randomized, controlled clinical study,21 women underwent a second-look laparoscopy 2–11 weeksafter standardized laparoscopic electrosurgical treatment forpolycystic ovarian syndrome (PCOS). Following bilateral ovariantreatment, one ovary was randomly chosen to have Interceed appliedto its surface using a specially designed applicator, with theother ovary serving as a control. Peri-adnexal adhesions ofsignificant extent and severity developed in 57% of the womenand 38% of the adnexa. The incidence of adhesions on the Interceed-treatedside was 43%, while on the control side it was 33%. In addition,the extent and severity of the adhesions appeared to be similaron the Interceed-treated and the control side. However, largernumbers would be required to determine statistically the effectsof Interceed on de-novo adhesion formation after laparoscopicelectro-surgical treatment of PCOS, as described here.     

Adhesion preventive effect of hyaluronic acid after intraperitoneal surgery in mice.

Prevention of intraperitoneal adhesion after gynaecological surgery is essential for maintaining postoperative fertility. In this study, the adhesion prevention effect was examined of a hyaluronic acid (HA) solution obtained from the fermentation method and having a molecular weight of 1.9x10(6) with high viscosity. Laparotomy was conducted on female mice 7 weeks old, whose menstrual periods were synchronized by pregnant mare serum gonadotrophin (PMSG) to injure the uterine horn surface. Intraperitoneal adhesions were favourably formed in 91.7% of cases induced with iodine abrasion, compared with 50% induced by electrosurgery. Intraperitoneal administration of HA was evaluated for its effect on the prevention of adhesions made by iodine abrasion. Adhesion prevention effects of HA were observed at concentrations of 0.3, 0.5, 0.75 and 1.0%, among which the most pronounced effect was with the use of a 0.3% solution (92.3% of cases). Compared with the control group adhesion score of 2.0 +/- 0. 8, significant decreases in adhesion scores were observed at all concentrations. HA with a molecular weight of 1.9x10(6) was recognized to have a definitive prevention effect on postoperative adhesions in mice after laparotomy and is considered to be a prospective material for future clinical use.     

The role of laparoscopy in intrauterine insemination: a prospective randomized reallocation study

BACKGROUND: We questioned whether a laparoscopy should be performed after a normal hysterosalpingography before starting intrauterine inseminations (IUI) in order to detect further pelvic pathology and whether a postponed procedure after six unsuccessful cycles of IUI yields a higher number of abnormal findings. METHODS: In a randomized controlled trial, the accuracy of a standard laparoscopy prior to IUI was compared with a laparoscopy performed after six unsuccessful cycles of IUI. The major end-point was the number of diagnostic laparoscopies revealing pelvic pathology with consequence for further treatment such as laparoscopic surgical intervention, IVF or secondary surgery. Patients were couples with medical grounds for IUI such as idiopathic subfertility, mild male infertility and cervical hostility. RESULTS: Seventy-seven patients were randomized into the diagnostic laparoscopy first (DLSF) group and the same number was randomized into the IUI first (IUIF) group. The laparoscopy was performed on 64 patients in the DLSF group, 10 patients withdrew their consent from participation and three patients (3%) became pregnant prior to laparoscopy. In the IUIF group, 23 patients remained for laparoscopy because pregnancy did not occur after six cycles of IUI. From the original 77 randomized patients, 38 patients became pregnant and 16 patients dropped out. Abnormal findings during laparoscopy with therapeutic consequences were the same in both groups: in the DLSF group, 31 cases (48%) versus 13 cases (56%) in the IUIF group, P = 0.63; odds ratio (OR) = 1.4; 95% confidence interval (CI): 0.5-3.6. The ongoing pregnancy rate in the DLSF group was 34 out of 77 patients (44%) versus 38 out of 77 patients (49%) in the IUIF group (P = 0.63; OR = 1.2; 95% CI: 0.7-2.3). CONCLUSIONS:Laparoscopy performed after six cycles of unsuccessful IUI did not detect more abnormalities with clinical consequences compared with those performed prior to IUI treatment. Our data suggest that the impact of the detection and the laparoscopic treatment of observed pelvic pathology prior to IUI seems negligible in terms of IUI outcome. Therefore, we seriously question the value of routinely performing a diagnostic and/or therapeutic laparoscopy prior to IUI treatment. Further prospective studies could be performed to determine the effect of laparoscopic interventions on the success rate of IUI treatment in order to rule out completely the laparoscopy from the diagnostic route prior to IUI.     

Endometrial polyps and their implication in the pregnancy rates of patients undergoing intrauterine insemination: a prospective, randomized study

BACKGROUND: It was our intention to determine whether hysteroscopic polypectomy before intrauterine insemination (IUI) achieved better pregnancy outcomes than no intervention. METHODS: A total of 215 infertile women from the infertility unit of a university tertiary hospital with ultrasonographically diagnosed endometrial polyps (EP) undergoing IUI were randomly allocated to one of two pretreatment groups using an opaque envelope technique with assignment determined by a random number table. Hysteroscopic polypectomy was performed in the study group. Diagnostic hysteroscopy and polyp biopsy was performed in the control group. RESULTS: Total pregnancy rates and time for success in both groups after four IUI cycles were compared by means of contingency tables and life-table analysis. A total of 93 pregnancies occurred, 64 in the study group and 29 in the control group. Women in the study group had a better possibility of becoming pregnant after polypectomy, with a relative risk of 2.1 (95% confidence interval 1.5-2.9). Pregnancies in the study group were obtained before the first IUI in 65% of cases. CONCLUSIONS: These data suggest that hysteroscopic polypectomy before IUI is an effective measure.     

A randomized, controlled pilot study of the safety and efficacy of 4% icodextrin solution in the reduction of adhesions following laparoscopic gynaecological surgery

BACKGROUND: Adhesion-related readmissions are frequent sequelae to gynaecological surgery. Attempts to prevent adhesions by separating healing peritoneal surfaces include site-specific barriers and hydroflotation by instilled solutions. Rapid absorption limits the effectiveness of solutions such as Ringer's lactated saline (RLS). This pilot study assessed the safety, tolerability and preliminary effectiveness of a non-viscous, iso-osmolar solution of 4% icodextrin, an alpha-1,4 glucose polymer with prolonged intraperitoneal residence, in reducing adhesions after laparoscopic gynaecological surgery. METHODS: Women aged > or = 18 years, requiring laparoscopic adnexal surgery (n = 62), were entered into a randomized, open-label, assessor-blinded, multicentre study to compare 4% icodextrin with RLS. Treatments were coded in blocks of four with equal randomization to each group, and pre-allocated to consecutively numbered patients. At least 100 ml per 30 min was used for intra-operative lavage, with 1 l instilled post-operatively. Per protocol analysis included all eligible patients (n = 53); reformation analysis required one or more baseline adhesion (n = 42). Incidence, extent and severity of post-operative adhesions were assessed at second-look laparoscopy after 6-12 weeks. Procedures were video-taped for third party, blinded assessment. RESULTS: Safety and tolerability (laboratory variables, adverse events, clinical follow-up) were good with no difference between treatments. A shift analysis of incidence-ranked adhesions (n = 53) showed apparent improvements in more patients with icodextrin than RLS (37 versus 15%; not significant). Adhesion score reduction (n = 42) was more frequent in icodextrin- than RLS-treated patients: incidence (52 versus 32%), extent (52 versus 47%), and severity (65 versus 37%). Despite greater baseline adhesions, median reformation was less after icodextrin (24%) than RLS (60%). The pilot study group sizes were not powered for statistical significance. CONCLUSIONS: In this preliminary study, 4% icodextrin lavage plus instillation was well tolerated and reduced adhesion formation and reformation following laparoscopic gynaecological surgery. A Phase III pivotal study is currently in progress.     

The type of catheter has no impact on the pregnancy rate after intrauterine insemination: a randomized study

BACKGROUND: This study was done to test the hypothesis that intrauterine insemination (IUI) using a soft-tip catheter results in a higher live birth rate than IUI using a hard-tip catheter. METHODS: Five hundred and forty patients were randomized into those inseminated with a soft-tip catheter (group 1, n = 267) and those inseminated with a hard-tip catheter (group 2, n = 269). Four patients were excluded. Main outcome measures included pregnancy rate and live birth rate per cycle. RESULTS: Both groups were similar with regard to female age, duration of infertility, ovarian stimulation and sperm quality. No significant differences were observed between group 1 and group 2 regarding clinical pregnancy rate per cycle (20 versus 19%), live birth rate per cycle (15 versus 14%), multiple live birth rate per cycle (4 versus 6%) and multiple live birth per total of live births (5 versus 8%, overall 6%), respectively. CONCLUSION: Our hypothesis that IUI using a soft tip catheter results in a higher live birth rate per cycle than IUI using a hard-tip catheter was not confirmed in this study. Multiple live birth rate after treatment with low-dose gonadotrophins and IUI can be kept low (6%).     

Value of the sperm chromatin dispersion test in predicting pregnancy outcome in intrauterine insemination: a blind prospective study

BACKGROUND: Sperm DNA integrity has been used as a new marker of sperm quality in the prediction of pregnancy. Nevertheless, no previous study has been performed by analysing the same samples that were employed in assisted reproduction. The main objective of this work was to correlate sperm chromatin dispersion (SCD), measured by the SCD test, with semen parameters and pregnancy outcome in intrauterine insemination (IUI). METHODS: A total of 100 semen samples obtained from males of couples undergoing IUI were analysed by the SCD test before and after swim-up, and the results were correlated with semen parameters and pregnancy outcome. RESULTS: SCD was negatively correlated with sperm motility in both ejaculated and processed semen. Sperm recovered by swim-up did not show a significant improvement in DNA integrity. No correlation was found between SCD and pregnancy outcome in IUI. CONCLUSIONS: DNA dispersion, as measured by the SCD test, is not correlated with pregnancy outcome in IUI.     

Cervical priming with sublingual misoprostol prior to insertion of an intrauterine device in nulliparous women: a randomized controlled trial

BACKGROUND: The copper intrauterine device (IUD) is a highly effective andsafe contraceptive method, also in nulliparous women. However,insertion of an IUD through a narrow cervix may be technicallydifficult. Misoprostol has been shown to be effective for cervicalpriming in non-pregnant women prior to hysteroscopy. METHODS: Eighty nulliparous women requesting an IUD were randomly allocatedto receive sublingually 400 µg misoprostol and 100 mgdiclofenac (misoprostol group) or 100 mg diclofenac alone (controlgroup) 1 h prior to IUD insertion. Cervical dilatation was measuredprior to insertion using Hegar pins. Ease of insertion was judgedby the investigator. Pain, bleeding and side effects were recordedat insertion and until follow-up performed one month later. RESULTS: Following treatment with misoprostol, insertion was significantlyeasier than in the control group [P = 0.039, difference 19.36%,confidence interval (CI) –0.013, 39.99]. Pain estimatedon a visual analogue scale (1–10) showed no evidence ofa difference between the groups. The overall distribution ofside effects did not differ. However, shivering was more commonin the misoprostol group (P = 0.0084, difference 23.27%, CI6.64, 39.90). CONCLUSIONS: Misoprostol facilitates insertion of an IUD, and reduces thenumber of difficult and failed attempts of insertions in womenwith a narrow cervical canal. The optimal regimen of misoprostolremains to be defined.     

Transfer of zona-free embryos improves outcome in poor prognosis patients: a prospective randomized controlled study

Assisted zona hatching (AZH) has been used in IVF programmes for several years. Recently one group has reported successful pregnancies after transfer of zona-free blastocysts. The aim of our study was to evaluate outcomes after transfer of zona-free day 3 embryos. Two groups of women undergoing intracytoplasmic sperm injection (ICSI) were included in the study. Group A consisted of 52 women under the age of 40 years undergoing their first ICSI attempt. They were alternately randomized to receive zona-free embryos (27 women) and zona-intact embryos (25 women). The second group (group B) included 71 women with a poor prognosis, as defined by age 40 years or more, and/or at least two previous failed IVF/ICSI attempts. They were randomized in a 3:4 ratio (30 zona-free, 41 zona-intact). Acid Tyrode's solution was used to remove the zona pellucida before embryo transfer on day 3 after oocyte collection. The pregnancy rate in group A was not significantly improved when the zona pellucida was removed. However, in the poor prognosis group B, zona removal resulted in a significantly higher pregnancy rate when compared with controls (23 versus 7.3%). We conclude that complete removal of the zona pellucida can improve pregnancy rates in women with poor IVF/ICSI prognosis.     

Comparison of different gonadotrophin preparations in intrauterine insemination cycles for the treatment of unexplained infertility: a prospective, randomized study

BACKGROUND: A comparison of the effectiveness of different gonadotrophin preparations in intrauterine insemination (IUI) cycles for patients with unexplained infertility was performed. METHODS: Two hundred and forty-one patients were prospectively randomized using computer-generated random numbers into three groups: 81 in the Follitropin alpha (Group I), 80 in the urinary FSH (uFSH) (Group II) and 80 in the hMG (Group III). The primary outcome was clinical pregnancy rate with duration of stimulation, total gonadotrophin dose, number of dominant follicles, clinical pregnancy rate, multiple pregnancy, miscarriage rate and ovarian hyperstimulation syndrome (OHSS) rate being secondary outcomes. RESULTS: Clinical pregnancy rate was significantly higher in the rFSH group (25.9% in Follitropin alpha, 13.8% in uFSH and 12.5% in HMG groups; P = 0.04). There was no significant difference in terms of duration of stimulation, but mean FSH dose consumed per cycle was significantly lower in the recombinant FSH (rFSH) group compared with others (825 IU in Follitropin alpha, 1107 IU in uFSH and 1197 IU in HMG groups; P = 0.001). The number of follicles > or =16 mm diameter was significantly higher in the rFSH group compared with the uFSH and HMG groups (2.6 in Follitropin alpha, 1.3 in uFSH and 1.4 in HMG groups; P = 0.001). CONCLUSION: rFSH may result in a better outcome in IUI cycles for unexplained infertility.     

Dose-finding study of triptorelin acetate for prevention of a premature LH surge in IVF: a prospective, randomized, double-blind, placebo-controlled study

Gonadotrophin-releasing hormone agonists (GnRHa) are routinely used in IVF programmes to prevent an unwanted LH surge and consequent ovulation. Despite its widespread use in IVF, a convincing dose recommendation for GnRHa in IVF does not exist. In our opinion, the lowest possible dose of GnRHa should be used. Thus, we performed a prospective, randomized, double-blind, placebo-controlled study to determine the minimal daily dose of triptorelin acetate needed to suppress a premature LH surge during IVF treatment in a long protocol. A total of 240 women (60 in each group) was randomized to either placebo or to one of three doses of triptorelin, i.e. 15, 50 or 100 microg daily. Ovarian stimulation was performed with two or three ampoules of FSH daily. A premature LH surge occurred in 23% of placebo-treated patients, but in none of the triptorelin acetate-treated patients. There were significantly more oocytes and embryos in the 50 and 100 microg triptorelin groups. There was no dose relationship in rates of either implantation, pregnancy, ongoing pregnancy, live birth or baby take-home. In this study we showed that daily administration of 15 microg triptorelin is sufficient to prevent a premature LH surge, and that 50 microg is equivalent to 100 microg in terms of IVF results.     

Results from a prospective, randomized, controlled study evaluating the acceptability and effects of routine pre-IVF counselling

BACKGROUND: The aim of this study was to evaluate a model of routine pre-IVF counselling focusing on the narrative capacities of couples. The acceptability of counselling, the effects on emotional factors and the participants' assessments were considered. METHODS: The study included 141 consecutive childless couples preparing for their first IVF. Randomization was carried out through sealed envelopes attributing participants to counselled and non-counselled groups and was accepted by 100 couples. Another 12 couples refused randomization because they wanted counselling and 29 because they did not. Questionnaires including the State-Trait Anxiety Inventory, the Beck Depression Inventory and assessments of help were mailed to couples before IVF and counselling, and after the IVF outcome. RESULTS: Counselling was accepted by 79% (112/141) of couples. There was no significant effect of counselling on anxiety and depression scores which were within normal ranges at both times. Counselling provided help for 86% (75/87) of initially non-demanding subjects and 96% (25/26) of those initially requesting a session. Help was noted in areas of psychological assistance, technical explanations and discussing relationships. CONCLUSIONS: This model of routine counselling centred on the narrative provides an acceptable form of psychological assistance for pre-IVF couples.     

Shortened exposure of oocytes to spermatozoa improves in-vitro fertilization outcome: a prospective, randomized, controlled study.

A prospective, randomized study of 158 patients undergoing in-vitro fertilization (IVF) and embryo transfer was conducted to evaluate whether a shortened exposure of oocytes to spermatozoa enhances oocyte development, and subsequently influences the IVF outcome. A comparison was made between conventional treatment time and shorter exposure of retrieved oocytes to spermatozoa. Fertilization and cleavage rates, embryo quality, implantation and pregnancy rates in the study group (short exposure) versus controls (standard IVF procedure) were evaluated. Fertilization (56 versus 61%) and cleavage rates (96 versus 92%) were similar in the two groups respectively. However, embryo quality was significantly higher in the study group (P < 0.05). Moreover, the pregnancy and implantation rates were significantly increased (42.4 versus 26% per embryo transfer, and 16 versus 10% respectively; P < 0.05). Our results demonstrated that shorter exposure of oocytes to spermatozoa is superior to the standard time in IVF and may have a favourable effect on implantation rates by improving embryo quality.     

Effect of using an echogenic catheter for ultrasound-guided embryo transfer in an IVF programme: a prospective, randomized, controlled study

BACKGROUND: Recent evidence showed that ultrasound-guided embryo transfer significantly increases successful implantation compared to the clinical touch method. It has been postulated that new echodense catheters which are more readily detectable by ultrasound may refine transfer techniques even more, thus improving IVF outcome. METHODS: A prospective, randomized, controlled trial comparing IVF outcome for women undergoing embryo transfer under ultrasound guidance by a single healthcare provider with random assignment according to a computer-generated randomization table to either standard soft Wallace catheter (standard catheter group, n=95) or the new echogenic soft Wallace catheter (echogenic catheter group, n=98). RESULTS: The use of the echodense catheter facilitated catheter identification under ultrasound, and thus the duration of the embryo transfer procedure since the loaded catheter was handed to the physician and up to embryo discharge was significantly shorter in the echogenic catheter group as compared with the standard catheter group. There were 39 and 53 clinical pregnancies in the standard catheter (41%) and echogenic catheter (54.1%) groups, respectively. This was not statistically significant (P=0.08) according to the OR (0.6) and CIs (0.33-1.04). However, twin pregnancy rate was significantly increased (P<0.01) with the use of the new catheter which was the underlying source for obtaining significant increase in implantation rate in this group (37.1%) as compared with the standard catheter group (23.2%). CONCLUSION: This pilot study suggests that the use of the echogenic Wallace catheter simplifies ultrasound-guided embryo transfer but not definite benefit in terms of pregnancy rates was obtained. In contrast, the use of the new catheter was associated with a significant increase in the number of twin pregnancies.     

Infertility: Higher pregnancy rates with a simple method for Fallopian tube sperm perfusion, using the cervical clamp double nut bivalve speculum in the treatment of unexplained infertility: a prospective randomized study

The object of this study was to evaluate the efficacy of thenewly developed cervical clamp double nut bivalve (DNB) speculumused for Fallopian tube sperm perfusion (FSP) with 4 ml of theinseminate, in comparison with standard intrauterine insemination(IUI) using a volume of 0.5 ml of the inseminate. Couples withunexplained infertility (n = 104), undergoing 202 cycles, wereenrolled in this study. Cycles were assigned randomly to eitherIUI (group A, n = 92) or FSP + DNB speculum^® (group B, n= 110). Ovarian stimulation was achieved using three differentovarian stimulation protocols in both groups. The age and folliculardevelopment of the patients were similar in both groups. Theserum hormonal measurements and the endometrial thickness wasalso similar on the day of human chorionic gonadotrophin (HCG)administration. The mean (± SD) number of motile spermatozoainseminated was 44.83 ± 16.57 x 10⁶ in group A and 42.68± 13.44 x 10⁶ in group B. In group A (IUI), 11 clinicalpregnancies (presence of gestational sac with heart beats) occurred(11.95% per cycle). In group B (FSP + DNB speculum^®) 29clinical pregnancies occurred (26.36% per cycle). These differenceswere statistically significant (P <0.001). The results ofthis study for the treatment of unexplained infertility indicatethat this simple, well tolerated, inexpensive method of usingthe DNB speculum for FSP is more successful than standard IUI.     

Effectiveness of combined GnRH analogue plus raloxifene administration in the treatment of uterine leiomyomas: a prospective,randomized, single-blind,placebo-controlled clinical trial

BACKGROUND: Raloxifene hydrochloride is a synthetic non-steroidal drug used for the prevention and treatment of post-menopausal osteoporosis. Pre-clinical and clinical data have shown that raloxifene may have a beneficial effect on leiomyomas. The aim of this prospective single-blind, randomized, placebo-controlled clinical trial was to evaluate the effectiveness of the addition of raloxifene to GnRH analogues on uterine, leiomyoma, and non-leiomyoma sizes, and on the occurrence of leiomyoma-related symptoms. METHODS: After randomization using a computer-generated list, 100 pre-menopausal women with symptomatic uterine leiomyomas received either leuprolide acetate depot plus raloxifene 60 mg daily (group A) or leuprolide plus placebo tablet (group B) for six cycles of 28 days. At baseline and after treatment, uterine, leiomyoma and non-leiomyoma sizes, and leiomyoma-related symptoms were evaluated for each woman. Analysis was by intention-to-treat method. RESULTS: After six cycles of treatment, a significant decrease in uterine, leiomyoma, and non-leiomyoma sizes was detected in both groups in comparison with baseline. At the same time, no significant difference in uterine and non-leiomyoma sizes was observed between the groups. Leiomyoma sizes were significantly (P < 0.05) lower in group A than in group B. No difference was observed in leiomyoma-related symptoms between groups throughout the study period. CONCLUSIONS: In women treated with GnRH analogue, the raloxifene administration induces a higher reduction of leiomyoma sizes.