Intracytoplasmic morphologically selected sperm injection versus conventional intracytoplasmic sperm injection: a randomized controlled trial.

BACKGROUND: Intracytoplasmic morphologically selected sperm injection (IMSI) is still proposed and employed in the clinical practice to improve the reproductive outcome in infertile couples scheduled for conventional intracytoplasmic sperm injection (cICSI). The aim of the current randomized controlled trial (RCT) was to test the hypothesis that IMSI gives a better live birth delivery rate than cICSI. METHODS: Infertile couples scheduled for their first cICSI cycle for male factor were allocated using a simple randomization procedure. All available biological and clinical data were recorded and analyzed in a triple-blind fashion. RESULTS: Our final analysis involved the first 121 patients (48 and 73 subjects for IMSI and cICSI arm, respectively) because the trial was stopped prematurely on the advice of the data safety and monitoring Committee because of concerns about IMSI efficacy at the first interim analysis. No significant difference between arms was detected in rates of clinical pregnancy per embryo transferred [11/34 (32.3%) vs. 15/64 (23.4%); odds ratio (OR) 1.56, 95% (confidence interval) CI 0.62-3.93, P = 0.343] and of live birth delivery [9/48 (18.8%) vs. 11/73 (15.1%); OR 1.30, 95%CI 0.49-3.42, P = 0.594). CONCLUSION: Current data did not support the routine use of IMSI in the clinical practice for improving cICSI results in unselected infertile couples with male factor.

Safety and efficacy of the minilaparotomy for myomectomy: a systematic review and meta-analysis of randomized and non-randomized controlled trials.

Myomectomy is the most frequent reproductive surgery to preserve, improve fertility, or both. The present study was designed to assess the safety and efficacy of minilaparotomy for myomectomy through a systematic review of randomized and non-randomized controlled trials with a meta-analysis. All available studies comparing minilaparotomy myomectomy with laparotomy, other minimally invasive surgeries, or both, were included. Available surgical and reproductive data were extrapolated, and a qualitative and quantitative analysis was carried out. Fourteen studies were included in the final analysis for an overall sample of 2151 patients. A total of 1139 patients were treated with minilaparotomy, whereas 239 and 773 patients were treated, respectively, with the laparotomy or laparoscopy. Only two studies comparing minilaparotomy with laparoscopy assessed the reproductive outcomes, and their data synthesis did not demonstrate significant difference between the two surgical techniques. Specific surgical end-points differed significantly between minilaparotomy and laparotomy or laparoscopy, even if those differences were not clinically relevant. In conclusion, current data do not permit a definite conclusion to be drawn. Further studies are needed to clarify the risk-benefit ratio of the minilaparotomy compared with the other minimally invasive surgical procedures for myomectomy to provide clinical recommendations with strong scientific evidence.

Lipid profile in nonobese pregnant women with polycystic ovary syndrome: a prospective controlled clinical study.

Alterations in lipid pattern and increased risk for obstetric/neonatal complications have been observed in patients with polycystic ovary syndrome (PCOS). Pregnancy leads to physiologic changes in lipoprotein metabolism, and alterations in lipid profile have been related with adverse pregnancy outcomes. Based on these considerations, the aim of the present prospective controlled clinical study was to test the hypothesis that the changes in the lipid profile in patients with PCOS during pregnancy are characteristic and potentially related to the increased risk of obstetric/neonatal complications. One hundred and fifty nonobese PCOS women and 150 age- and body mass index (BMI)-matched healthy controls were enrolled. Serum lipids, glucose, insulin, and androgens levels were serially assayed in all subjects before and throughout pregnancy. Serum low-density lipoprotein (LDL) and triglyceride (TG) concentrations were significantly (P<0.05) higher in PCOS group than in healthy controls at each assessment. Throughout pregnancy, serum LDL and TG levels increased significantly (P<0.05) in both groups, although the change from pre-pregnancy values was significantly (P<0.05) greater in PCOS patients than in healthy controls. A significant (P<0.05) relationship was observed between serum LDL and TG changes and changes in both insulin sensitivity indexes and androgen levels in PCOS patients alone. After adjusting for maternal age, pre-pregnancy BMI and lipid levels, body weight gain, and insulin-resistance markers, serum TG concentrations during pregnancy were directly and independently associated with obstetric complications in both groups, whereas serum LDL levels only in PCOS patients. We can conclude that nonobese PCOS patients had specific changes in lipid profile during pregnancy, and that the lipid pattern typical of PCOS may account for the more frequent adverse pregnancy outcomes. PCOS-related hormonal and metabolic features, such as insulin resistance and high androgen levels, may mediate this phenomenon.