Several protocols are actually available for in Vitro Fertilization and Embryo Transfer. The review summarizes the main differences and the clinic characteristics of the protocols in use with GnRH ...agonists and GnRH antagonists by emphasizing the major outcomes and hormonal changes associated with each protocol. The majority of randomized clinical trials clearly shows that in "in Vitro" Fertilization and Embryo Transfer, the combination of exogenous Gonadotropin plus a Gonadotropin Releasing Hormone (GnRH) agonist, which is able to suppress pituitary FSH and LH secretion, is associated with increased pregnancy rate as compared with the use of gonadotropins without a GnRH agonist. Protocols with GnRH antagonists are effective in preventing a premature rise of LH and induce a shorter and more cost-effective ovarian stimulation compared to the long agonist protocol. However, a different synchronization of follicular recruitment and growth occurs with GnRH agonists than with GnRH antagonists. Future developments have to be focused on timing of the administration of GnRH antagonists, by giving a great attention to new strategies of stimulation in patients in which radio-chemotherapy cycles are needed.
The efficacy and side-effect profile of ulipristal acetate as compared with those of leuprolide acetate for the treatment of symptomatic uterine fibroids before surgery are unclear.
In this ...double-blind noninferiority trial, we randomly assigned 307 patients with symptomatic fibroids and excessive uterine bleeding to receive 3 months of daily therapy with oral ulipristal acetate (at a dose of either 5 mg or 10 mg) or once-monthly intramuscular injections of leuprolide acetate (at a dose of 3.75 mg). The primary outcome was the proportion of patients with controlled bleeding at week 13, with a prespecified noninferiority margin of -20%.
Uterine bleeding was controlled in 90% of patients receiving 5 mg of ulipristal acetate, in 98% of those receiving 10 mg of ulipristal acetate, and in 89% of those receiving leuprolide acetate, for differences (as compared with leuprolide acetate) of 1.2 percentage points (95% confidence interval CI, -9.3 to 11.8) for 5 mg of ulipristal acetate and 8.8 percentage points (95% CI, 0.4 to 18.3) for 10 mg of ulipristal acetate. Median times to amenorrhea were 7 days for patients receiving 5 mg of ulipristal acetate, 5 days for those receiving 10 mg of ulipristal acetate, and 21 days for those receiving leuprolide acetate. Moderate-to-severe hot flashes were reported for 11% of patients receiving 5 mg of ulipristal acetate, for 10% of those receiving 10 mg of ulipristal acetate, and for 40% of those receiving leuprolide acetate (P<0.001 for each dose of ulipristal acetate vs. leuprolide acetate).
Both the 5-mg and 10-mg daily doses of ulipristal acetate were noninferior to once-monthly leuprolide acetate in controlling uterine bleeding and were significantly less likely to cause hot flashes. (Funded by PregLem; ClinicalTrials.gov number, NCT00740831.).
Summary Background Carboplatin plus paclitaxel administered every 3 weeks is standard first-line chemotherapy for patients with advanced ovarian cancer. A weekly paclitaxel schedule combined with ...carboplatin every 3 weeks prolonged progression-free survival and overall survival in a Japanese phase 3 trial. The aim of our study was to assess whether a weekly schedule of carboplatin plus paclitaxel is more effective than the same drugs given every 3 weeks. Methods We did a multicentre, randomised, phase 3 study at 67 institutions in Italy and France. Women with FIGO stage IC–IV ovarian cancer, an ECOG performance status of 2 or lower, and who had never received chemotherapy were randomly allocated in a 1:1 ratio to receive either carboplatin (AUC 6 mg/mL per min) plus paclitaxel (175 mg/m2 ) every 3 weeks for six cycles or carboplatin (AUC 2 mg/mL per min) plus paclitaxel (60 mg/m2 ) every week for 18 weeks. Randomisation was done by computer-based minimisation, stratified by centre, residual disease after surgery, and ECOG performance status. The study was not blinded. Coprimary endpoints were progression-free survival and quality of life (assessed by the Functional Assessment of Cancer Therapy Ovarian Trial Outcome Index FACT-O/TOI score), and analysis was by modified intention to treat. This report presents the final analysis. The study is registered with ClinicalTrials.gov , number NCT00660842. Findings 822 patients were enrolled into the study between Nov 20, 2008, and March 1, 2012; 12 withdrew their consent immediately after randomisation and were excluded, and 810 were eligible for analysis. 404 women were allocated treatment every 3 weeks and 406 were assigned to the weekly schedule. After median follow-up of 22·3 months (IQR 16·2–30·9), 449 progression-free survival events were recorded. Median progression-free survival was 17·3 months (95% CI 15·2–20·2) in patients assigned to treatment every 3 weeks, versus 18·3 months (16·8–20·9) in women allocated to the weekly schedule (hazard ratio 0·96, 95% CI 0·80–1·16; p=0·66). FACT-O/TOI scores differed significantly between the two schedules (treatment-by-time interaction p<0·0001); with treatment every 3 weeks, FACT-O/TOI scores worsened at every cycle (weeks 1, 4, and 7), whereas for the weekly schedule, after transient worsening at week 1, FACT-O/TOI scores remained stable. Fewer patients assigned to the weekly group than those allocated treatment every 3 weeks had grade 3–4 neutropenia (167 42% of 399 patients vs 200 50% of 400 patients), febrile neutropenia (two 0·5% vs 11 3%), grade 3–4 thrombocytopenia (four 1% vs 27 7%), and grade 2 or worse neuropathy (24 6% vs 68 17%). Three deaths during the study were attributed to chemotherapy; two women died who were allocated treatment every 3 weeks and one death was recorded in the group assigned the weekly regimen. Interpretation A weekly regimen of carboplatin and paclitaxel might be a reasonable option for first-line treatment of women with advanced ovarian cancer. Funding None.
To assess the accuracy and characterize two-dimensional ultrasonographic formulas for the estimation of birth weight according to the type of fetal biometric parameters these formulas rely on to make ...fetal weight predictions.
A prospective recruitment of 589 pregnant women was carried out for this cross-sectional study. Different biometric parameters were taken ultrasonographically to estimate birth weight using 35 different formulas. Only those patients who delivered within 48 hours were considered for the analysis (n=441). Differences between the estimated and actual birth weight were assessed by percentage error, accuracy in predictions within +/-10% and +/-15% of error, and use of the Bland-Altman method. All formulas were assessed individually and clustered on the basis of the type of fetal biometric information that they incorporate.
Twenty-nine formulas provided an overall mean absolute percentage error less than or equal to 10%, with overall predictions within +/-10% and +/-15% of the actual birth weight (69.2% and 86.5%, respectively). Twenty formulas showed a good accuracy (bias 0.50 or less) and low variability (mean standard deviation 1.2). Among the categorized algorithms, formulas based on head-abdomen-femur measurements showed the lowest mean absolute percentage error. Upon stratification for birth weight, the group of formulas that rely on abdomen and femur measurements performed best for fetuses weighing more than 3,500 g (P<.01).
Our findings show that most formulas are relatively accurate at predicting birth weight up to 3,500 g, and all algorithms tend to underestimate large fetuses.
III.
Background
To evaluate the safety and feasibility of the new robotic TELELAP ALF-X platform in a heterogeneous series of gynecological procedures.
Methods
Between September 2013 and May 2014, 146 ...patients were enrolled in this Phase II study trial. Patients with presumed benign or borderline adnexal disease, and benign and early stage malignant uterine disease were prospectively included.
Results
Median age was 52 years (range 19–79 years), and median BMI was 23.7 (range 17.3–34.0 kg/m
2
). Sixty-two patients (32.5 %) underwent mono/bilateral salpingo-oophorectomy or cyst removal (Group A), four patients (2.7 %) myomectomy (Group B), 46 patients (31.5 %) total hysterectomy (Group C), and 34 (23.3 %) endometrial cancer staging (Group D). Median docking time was 7 min (range 3–36). Median OT was 35 min (range 17–145) in the Group A, 40 min (range 10–50) in the Group B, 133 min (range 58–320) in the Group C, and 160 min (range 69–290) in the Group D. Reduction in OT over the study period for hysterectomy (
p
< 0.001) and adnexal surgery (
p
< 0.002) was observed. We registered two laparoscopic conversion (3.2 %) in the Group A and two (4.3 %) in the Group C. In the Group D, we showed one (2.9 %) laparoscopic and two (5.8 %) laparotomic conversions. One patient (2.17 %) in the Group C was readmitted in the early postoperative period for severe vaginal bleeding.
Conclusions
We report the first series of a novel robotic approach for the treatment of various gynecological conditions. When performed by experienced minimally invasive surgeons, TELELAP ALF-X is feasible and safe. Further studies are mandatory to define the benefits, advantages, and costs of this new robotic approach with respect to others minimally invasive approaches.
To determine whether abagovomab maintenance therapy prolongs recurrence-free (RFS) and overall survival (OS) in patients with ovarian cancer in first clinical remission.
Patients with International ...Federation of Gynecology and Obstetrics stage III to IV ovarian cancer in complete clinical remission after primary surgery and platinum- and taxane-based chemotherapy were randomly assigned at a ratio of 2:1 in a phase III, double-blind, placebo-controlled, multicenter study. Abagovomab 2 mg or placebo was administered as 1-mL suspension once every 2 weeks for 6 weeks (induction phase) and then once every 4 weeks (maintenance phase) until recurrence or up to 21 months after random assignment of the last patient. The primary end point was RFS; secondary end points were OS and immunologic response.
Characteristics of the 888 patients included: mean age, 56.3 years; Eastern Cooperative Oncology Group performance status, ≤ 1 in > 99% of patients; serous papillary subtype, 81.5%; stage III, 85.9%; and cancer antigen 125 ≤ 35 U/mL after third cycle, 80.9%. Mean exposure to study treatment (± standard deviation) was 449.7 ± 333.08 days. Hazard ratio (HR) of RFS for the treatment group using tumor size categorization (≤ 1 cm, > 1 cm) was 1.099 (95% CI, 0.919 to 1.315; P = .301). HR of OS using tumor size categorization (≤ 1 cm, > 1 cm) was 1.150 (95% CI, 0.872 to 1.518; P = .322). The most frequently reported type of adverse event was an injection site reaction in 445 patients (50.2%), followed by injection site erythema and fatigue in 227 (25.6%) and 212 patients (23.9%), respectively. By the final visit, median anti-anti-idiotypic antibody level was 493,000.0 ng/mL, indicating a robust response.
Abagovomab administered as repeated monthly injections is safe and induces a measurable immune response. Administration as maintenance therapy for patients with ovarian cancer in first remission does not prolong RFS or OS.
Summary
The aim of this study was to assess the effect of human immunodeficiency virus (HIV), hepatitis C (HCV) and B (HBV) virus infection on semen parameters. Semen samples were obtained from 27 ...HCV, 34 HIV, 30 HBV and 41 HCV‐HIV‐seropositive patients and compared with those of a control population of healthy seronegative subjects. Tests for detection of HIV, HCV and HBV were performed on seminal samples. The sperm concentration was significantly decreased in HCV‐ and HBV‐seropositive males compared to that of controls (P < 0.001). The mean sperm motility (a + b) was significantly decreased in HCV‐ and HBV‐seropositive (P < 0.001) and in HCV‐HIV‐seropositive subjects (P < 0.05) compared to that of controls. The sperm viability was significantly lower in HCV‐ and HBV‐seropositive men than in controls (P < 0.001). The normal morphology was significantly reduced in HCV‐seropositive and HBV‐seropositive men (P < 0.05) with respect to that of controls (P < 0.05). The sperm concentration after sperm wash was significantly higher in controls than in HCV‐, HIV‐, HBV‐ and HIV‐HCV‐seropositive men (P < 0.001). We can conclude that HBV‐ and HCV‐infected men have a significantly impaired sperm quality compared with that of controls. The reason for the better sperm quality in our series of HIV‐ and HCV‐HIV‐infected men is still under debate. Further investigations in a larger case series are warranted.
OBJECTIVE: To identify a possible marker of follicular depletion in relation to some histologic parameters of endometriotic cysts. DESIGN: Prospective study. SETTING: Università Cattolica del Sacro ...Cuore, Operative Division of Endocrinological Gynecology. PATIENT(S): Seventy-seven patients (aged 20–40 years) with endometrioma. INTERVENTION(S): Patients underwent laparoscopic surgery for ovarian endometriosis. MAIN OUTCOME MEASURE(S): After excision of the cyst wall, involuntarily removed follicles were correlated with age at surgery and with intrinsic histologic parameters of the specimen (thickness and composition of capsule; size of cyst). RESULT(S): There was a statistically significant relationship between patient age and number of follicles in the histologic section, a statistically significant inverse relationship between size of cyst and number of follicles, and no significant correlation between thickness of the capsule and number of follicles. Fibroblastic-type capsule, most frequently found in younger patients, was associated with removal of a significantly higher number of follicles. CONCLUSION(S): Our study suggests that patient age and cyst dimension are related to the histologic composition of the capsule, which is a marker of the aggressiveness of the cyst itself.
To investigate metformin effects on the endocrine-metabolic parameters and ovarian morphology in normoinsulinemic women with polycystic ovary syndrome (PCOS).
Randomized double-blind study.
Operative ...Division of Endocrinological Gynecology, Università Cattolica del Sacro Cuore.
Twenty-eight normal-weight normoinsulinemic PCOS women.
Patients were randomized to receive metformin 500 mg twice a day (group A, 15 subjects) or placebo (group B, 13 subjects) for 6 months. Ultrasonographic pelvic exams, hormonal and lipid features, and oral glucose tolerance test were performed at baseline and after 3 and 6 months of treatment.
Hormonal and glycoinsulinemic assessment, ovarian ultrasound appearance.
Glycoinsulinemic assessment remained unvaried in both groups. About 70% of patients in group A experienced a restoration of menstrual cyclicity. Metformin significantly decreased testosterone levels at 3 and 6 months) and 17-hydroxyprogesterone levels at 6 months, and improved hirsutism score at 6 months. No clinical or hormonal modifications occurred in group B. Metformin, but not placebo, reduced ovarian volume and stromal/total area ratio at 3 and 6 months.
Metformin seems to improve the menstrual pattern and ultrasonographic ovarian features in normoinsulinemic PCOS women. These effects seem to be, at least in part, independent of the insulin-lowering properties of the drug.
This prospective single-institutional clinical trial sought to assess the safety and feasibility of laparoscopic benign ovarian cyst enucleation with a novel robotic-assisted laparoscopic system. ...Here we report a series of 10 patients treated using the Telelap ALF-X system in the first clinical application on patients at the Division of Gynecologic Oncology, Catholic University of the Sacred Heart of Rome. The primary inclusion criterion was the presence of monolateral ovarian cyst without a preoperative assessment suspicious for malignancy. Intraoperative data, including docking time, operative time, estimated blood loss, intraoperative and perioperative complications, and conversion to either standard laparoscopy or laparotomy, were collected. The cysts were removed with an ovary-sparing technique with respect to conservative surgical principles. The median operative time was 46.3 minutes, and patients without postoperative complications were discharged at 1 or 2 days after the procedure. Telelap ALF-X laparoscopic enucleation of benign ovarian cysts with an ovary-sparing technique is feasible, safe, and effective; however, more clinical data are needed to determine whether this approach can offer any other benefits over other minimally invasive surgical techniques.
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