The BNT162b2 mRNA Covid-19 vaccine does not impair sperm parameters.

RESEARCH QUESTION: Does the BNT162b2 COVID-19 vaccine affect sperm parameters of patients with a normal or an abnormal semen analysis? DESIGN: Data were collected from male patients undergoing IVF treatment after completing vaccination between February 2021 and June 2021 (post-vaccine). For comparison, records of the same patients were reviewed before the vaccination (pre-vaccine) back to January 2017. Patients with azoospermia were excluded. Sperm parameters were compared between pre- and post-vaccine groups. Each patient served as self-control. RESULTS: Seventy-two patients were included in the study (median interquartile range [IQR] age 35.7 [33.0-43.0] years), of whom 57 had a normal semen analysis. The time between the first vaccine and the post-vaccine sperm analysis was 71.0 (40.5-104.8) days. The sperm parameters before and after the vaccination were as follows: sperm volume before 3.0 (2.0-4.0) and after 3.0 (1.6-3.9) ml, P = 0.02; sperm concentration before 26.5 (14.0-64.7) and after 31.0 (14.2-80.0) 106/ml, P = 0.35; and total motile sperm count before 33.7 (9.0-66.0) and after 29 (6.0-97.5)106, P = 0.96. Sub-group analyses were conducted for patients with male infertility and patients with a normal semen analysis. Neither of the sub-groups showed significant changes after vaccination. CONCLUSION: Sperm parameters showed no significant changes after vaccination among men with a normal and abnormal semen analysis. Therefore, the BNT162b2 vaccine does not seem to affect sperm parameters. The preliminary results are reassuring for the entire global population, currently undergoing intense vaccination campaigns against COVID-19.

Pfizer SARS-CoV-2 BNT162b2 mRNA vaccination (BNT162b2) has no adverse effect on elective oocyte cryopreservation outcomes.

RESEARCH QUESTION: Do elective oocyte cryopreservation outcomes in women 1-13 months after SARS-CoV-2 vaccination alter compared with unvaccinated women and do different time intervals between vaccination and ovarian stimulation impact these outcomes? DESIGN: This retrospective cohort study, conducted in a university-affiliated IVF centre, included 232 elective oocyte cryopreservation cycles of vaccinated and unvaccinated patients, without previous infection with the SARS-CoV-2 virus, between December 2020 and January 2022. Two control groups - pre-pandemic (January 2019 to February 2020) and intra-pandemic (December 2020 to January 2022) unvaccinated groups - were compared with the vaccinated group, further divided into four subgroups (under 3, 3-6, 6-9 and 9-13 months). The primary outcome was the elective oocyte cryopreservation cycle outcomes - number of retrieved and number of mature oocytes. RESULTS: The vaccinated group demonstrated comparable outcomes with regards to number of retrieved and mature oocytes compared with the pre-pandemic and intra-pandemic unvaccinated groups (12.6 ± 8.0 versus 13.0 ± 8.2 and 12.5 ± 7.4 retrieved and 10.1 ± 6.9 versus 9.5 ± 6.4 and 10.1 ± 6.3 mature oocytes, respectively; not significant for both). Similar results were noted in a comparison between the intra-pandemic unvaccinated group and the four vaccinated subgroups. No correlation was found between the parameter of days from vaccination and cycle outcomes. Similarly, analysis of covariance showed no association between vaccination status and timing and number of mature oocytes. CONCLUSIONS: The SARS-CoV-2 vaccination does not alter the outcomes of elective oocyte cryopreservation procedures. This is true even in a relatively long time interval of 9 to 13 months from vaccination.

Sperm quality is not affected by the BNT162b2 mRNA SARS-CoV-2 vaccine: results of a 6-14 months follow-up.

PURPOSE: We aimed to investigate the possible effect of SARS-CoV-2 vaccination on sperm quality by evaluating semen analyses of men prior to vaccination and 6-14 months after vaccination. METHODS: This was a retrospective cohort study, conducted in a university-affiliated in vitro fertilization center between October 2021 and March 2022, including men not previously infected with the SARS-CoV-2 virus who received at least 2 doses of the Pfizer-BioNTech (BNT162b2) SARS-CoV-2 vaccine. Semen analyses of samples given pre-vaccination and 6-14 months post-vaccination were analyzed for the parameters of volume, concentration, motility, morphology, and total motile count (TMC) and compared. These parameters were also compared separately for men who received a third (booster) dose and for men with pre-vaccination normal and abnormal sperm. Correlations between time from vaccination and post-vaccination sperm parameters were also assessed. RESULTS: Fifty-eight men were included in the final analysis. Semen volume (2.9 ± 1.4 vs. 2.9 ± 1.6 ml), sperm concentration (42.9 ± 37.9 vs. 51.5 ± 46.2 million/ml), motility (42.5 ± 23.1 vs. 44.3 ± 23.4 percent), morphology (8.8 ± .16.6 vs. 6.6 ± 8.8 percent), and TMC (55.7 ± 57.9 vs. 71.1 ± 77.1 million) were comparable between the pre- and post-vaccination samples. This was true for the entire study cohort, for the subgroup of men who received a third dose and for the subgroups of men with a pre-vaccination normal and abnormal semen samples. No correlation was found between time from vaccination and post-vaccination sperm parameters. CONCLUSIONS: The Pfizer-BioNTech (BNT162b2) SARS-CoV-2 vaccine does not impair any of the sperm parameters over a relatively long-time interval of 6 to 14 months from vaccination.

Recurrent Tubal Ectopic Pregnancy Management and the Risk of a Third Ectopic Pregnancy.

STUDY OBJECTIVE: To evaluate the rate of a third ectopic pregnancy according to the modality of treatment of the second ectopic pregnancy. DESIGN: Retrospective cohort study. SETTING: University-affiliated tertiary medical center. PATIENTS: One hundred eleven women who had 2 ectopic pregnancies and a third consecutive pregnancy between 2003 and 2018. INTERVENTIONS: Surgery or medical treatment as required. MEASUREMENTS AND MAIN RESULTS: With regard to the modality of treatment of the second ectopic pregnancy, the patients were divided into 3 groups: expectant management, medical treatment with methotrexate, and laparoscopic salpingectomy. Univariate and multivariate analyses were conducted to assess the association of various parameters of the second ectopic pregnancy with the occurrence of a third ectopic pregnancy in the consecutive pregnancy. Twenty women (18.0%) were managed expectantly, 55 (49.6%) were treated with methotrexate, and 36 (32.4%) underwent surgery. Expectant management resulted in significantly higher rates of a third ectopic pregnancy compared with treatment with methotrexate or surgical intervention (50.0% vs 18.2% and 13.8%, respectively; p = .005). In the cases of 2 ipsilateral ectopic pregnancies, the interventional approach (medical or surgical treatment) resulted in lower recurrence rates compared with expectant management (25.7% vs 60.0%, respectively; p = .043). CONCLUSION: The risk of a third episode of an ectopic pregnancy after expectant management of a second ectopic pregnancy is extremely high. An interventional approach by treatment with methotrexate or salpingectomy is therefore preferred for recurrent ectopic pregnancy management, especially in ipsilateral recurrences.

A shift in follicular fluid from triacylglycerols to membrane lipids is associated with positive pregnancy outcome.

Follicular fluid (FF) is a liquid that surrounds the ovum. Its metabolite and, specifically, its lipid content have been associated with oocyte development. To characterize possible association between the lipid composition of FF and the outcome of pregnancy, we carried out a lipidomics study and compared the abundance of lipids from FF of patients with positive and negative outcomes. We found a differential lipid network wiring in positive-outcome FF, with a significant decrease (∼2 fold; P < 0.001) in triacylglycerol levels and higher accumulation (10-50%; P < 0.001) of membrane lipids groups (phospholipids and sphingolipids). In addition to this major metabolic alteration, other lipid groups such as cholesteryl esters showed lower levels in positive-outcome patients, whereas derivatives of vitamin D were highly accumulated in positive-outcome FF, supporting previous studies that associate vitamin D levels in FF to pregnancy outcome. Our data also point to specific lipid species with a differential accumulation pattern in positive-outcome FF that predicted pregnancy in a receiver operating characteristic analysis. Altogether, our results suggest that FF lipid network is associated with the oocyte development, with possible implications in diagnostics and treatment.-Shehadeh, A., Bruck-Haimson, R., Saidemberg, D., Zacharia. A., Herzberg, S., Ben-Meir, A., Moussaieff, A. A shift in follicular fluid from triacylglycerols to membrane lipids is associated with positive pregnancy outcome.

Association between uterine position and transvaginal misoprostol treatment for early pregnancy failure.

AIM: We aimed to determine the importance of uterine position as a predicting factor of success rate in medically treated early pregnancy failure (EPF). METHODS: We carried out a retrospective cohort study at the Obstetrics and Gynecology Department of a tertiary medical center between January 2011 and June 2012. We included women diagnosed with EPF, which we defined as women diagnosed with missed abortion up to 13 gestational weeks. Patients were treated with one or two doses of 800 µg of misoprostol vaginally in accordance with the department's protocol. Demographic, clinical, and treatment success data were collected from patient electronic records. RESULTS: A total of 255 women were included in our study. The success rate after treatment with misoprostol for the anterior uterine group was 78.7% as compared to the non-anterior uterine group, which achieved a success rate of 88.1%. This difference was not statistically significant (P = 0.180). In a multivariate analysis comparing patients for whom treatment with misoprostol was successful as opposed to patients for whom treatment failed, only embryonic sac size showed a statistically significant difference, measuring shorter in the success group. CONCLUSION: Uterine position has no effect on success rate of misoprostol treatment for EPF.

A "See and Treat" Office Procedure for Retained Products of Conception Removal After Normal Vaginal Delivery Using Manual Vacuum Aspiration: Preliminary Efficacy and Reproductive Outcomes.

STUDY OBJECTIVE: To compare the efficacy and reproductive outcomes of an ultrasound-guided manual vacuum aspiration (MVA) procedure with the widely accepted operative hysteroscopic (OH) procedure in the removal of retained products of conception (RPOCs) after normal vaginal delivery. DESIGN: A retrospective cohort study (Canadian Task Force classification II-2). SETTING: A university-affiliated tertiary medical center. PATIENTS: Eighty-six patients after normal vaginal delivery diagnosed with RPOCs from 2005 through 2015. This study was approved by the local institutional review board. INTERVENTIONS: Treatment with either MVA or OH for patients diagnosed with RPOCs. MEASUREMENTS AND MAIN RESULTS: Of 86 patients, 23 underwent remnant removal by ultrasound-guided MVA using a 6- to 7-mm catheter in a "see and treat" office procedure. Sixty-three patients underwent remnant removal using the OH procedure. Follow-up included sonographic examination 3 to 5 weeks after the procedure and long-term follow-up on complications and reproductive outcomes. Successful remnant evacuation and the overall complications rates were similar when comparing the MVA group and the OH group (95.7% vs 96.8% and 4.3% vs 4.7%, respectively). Conception rates and miscarriage rates were comparable in the MVA and OH groups (78.6% vs 72.2% and 9.1% vs 14.8%, respectively). CONCLUSION: Preliminary results from 23 patients suggest that MVA is an efficient procedure with low complication rates and satisfactory reproductive outcomes. It does not require anesthesia or operating room facilities, allowing an immediate and inexpensive "see and treat" option for RPOCs. Further larger controlled trials are required.

Long-term gynecological complications after conservative treatment of placenta accreta spectrum.

Objective: To examine the association between conservative treatment for PAS (placenta accreta spectrum) and subsequent gynecological and fertility complications. Methods: All women who underwent conservative treatment for PAS between January 1990 and December 2000 were included in this retrospective cohort study conducted in a tertiary teaching hospital. Gynecological and fertility complications experienced after the index delivery were collected from the medical records and telephone questionnaires. This data was compared to an age and parity-matched control group of women without PAS. Results: The study group included 134 women with PAS managed conservatively and 134 controls with normal deliveries matched by parity and age. Women in the PAS group required significantly more postpartum operative procedures such as hysteroscopy or D&C (OR = 6.6; 95%CI: 3.36-13.28; P = <0.001). Following the index delivery, there were 345 pregnancies among 107 women who attempted conception following conservative treatment for PAS vs. 339 pregnancies among 105 women who attempted conception in the control group. Among women who attempted conception following conservative treatment for PAS 99 (92.5%) delivered live newborns (a total of 280 deliveries) vs. 94 (89.5%) in the control group, (a total of 270 live newborns, p = 0.21). The need for fertility treatments was not different between the two groups (OR = 1.22; 95%CI: 0.51-2.93; P = 0.66). Conclusion: After conservative treatment for PAS, significantly more women required complementary procedures due to retained placenta and/or heavy vaginal bleeding. There was no evidence of fertility impairment in women post-conservative treatment for PAS.

Do vitrified frozen-thawed embryos generated from successful fresh cycles have higher potential for favorable outcome?

BACKGROUND: Many variables, including woman's age, embryo quality and endometrial receptivity, influence the success rate of either fresh embryo transfer (ET) or frozen-thawed ET (FT-ET) cycles. This study aims to examine whether the results of a fresh in-vitro fertilization (IVF) cycle correlate with its frozen-thawed embryos transfer outcomes. METHODS: A retrospective cohort study conducted in a tertiary medical center single IVF unit between 2014-2017. The study population was comprised of women who underwent fresh ET with the remaining embryos frozen using vitrification and at least one consecutive FT-ET cycle. Comparison of FT-ET cycle's details and outcomes were assessed in relation to the outcome of preceding fresh ET cycle. RESULTS: A total of 599 women underwent fresh ET and at least one consecutive FT-ET cycle. Significantly higher rates of successful FT-ET cycle outcomes were observed in the group of patients with a successful fresh cycle compared to the group with an unsuccessful fresh cycle (48.9% vs. 20.8%, P<0.001). Logistic regression demonstrated an adjusted OR of 5.02 for successful FT-ET after a successful fresh cycle. CONCLUSIONS: Frozen-thawed embryos generated from successful fresh IVF cycles have higher potential to implant when compared to frozen-thawed embryos obtained in an unsuccessful fresh cycle.

A Shift in Glycerolipid Metabolism Defines the Follicular Fluid of IVF Patients with Unexplained Infertility.

Follicular fluid (FF) constitutes the microenvironment of the developing oocyte. We recently characterized its lipid composition and found lipid signatures of positive pregnancy outcome after in vitro fertilization (IVF). In the current study, we aimed to test the hypothesis that unexplained female infertility is related to lipid metabolism, given the lipid signature of positive-outcome IVF patients we previously found. Assuming that FF samples from IVF patients with male factor infertility can represent a non-hindered metabolic microenvironment, we compared them to FF taken from women with unexplained infertility. FF from patients undergoing IVF was examined for its lipid composition. We found highly increased triacylglycerol levels, with a lower abundance of monoacylglycerols, phospholipids and sphingolipids in the FF of patients with unexplained infertility. The alterations in the lipid class accumulation were independent of the body mass index (BMI) and were altogether kept across the age groups. Potential lipid biomarkers for pregnancy outcomes showed a highly discriminative abundance in the FF of unexplained infertility patients. Lipid abundance distinguished IVF patients with unrecognized infertility and provided a potential means for the evaluation of female fertility.

Vacuum extraction failure is associated with a large head circumference.

Objective: To determine whether large head circumference increases the risk of vacuum extraction failure. Study design: This EMR-based study included all attempted vacuum extractions performed in a tertiary center between January 2010 and June 2015. All term singleton live births were eligible. Cases were divided into four groups: head circumference ≥90th percentile both with birth weight ≥90th percentile and <90th percentile and fetal head circumference <90th percentile with birth weight ≥90th and <90th percentile. Risk of failed vacuum extraction was compared among these groups. Other neonatal and maternal parameters were also evaluated as potential risk factors. Multinomial multivariable regression provided adjusted odds ratio for vacuum extraction failure while controlling for potential confounders. Results: During the study period, 48,007 deliveries met inclusion criteria, of which 3835 had an attempt at vacuum extraction. We identified 215 (5.6%) cases of vacuum extraction failure. The adjusted odds ratios (aOR) for vacuum extraction failure in cases of large fetal head circumference was 2.31 (95%CI, 1.7-3.15, p < .001). Primiparity, prolonged second stage and occipito-posterior presentation were also found to be significant risk factors for failed vacuum extraction. Comments: In this study, we found that large head circumference was associated with vacuum extraction failure rather than high birth weight.

Development of a nomogram for prediction of successful membrane sweeping.

OBJECTIVE: To evaluate the association of obstetric, maternal, and fetal variables with successful membrane sweeping and to develop a calculator that can predict spontaneous delivery within 24 hours of membrane sweeping. METHODS: This secondary analysis of the STRIP-G Study included all singleton term parturients who underwent membrane sweeping in a tertiary center in October 2011 to July 2013. Primary end point was a 24-hour time interval from sweeping to delivery. Women who delivered without formal induction within the 24-hour interval were included in the "successful sweeping group". Stepwise logistic regression was used to calculate the adjusted odds ratio (aOR) for successful membrane sweeping and to create the calculator. The predictive power of the calculator was evaluated by area under the curve (AUC) of the receiver operating characteristic (ROC) curve and by Nagelkerke R-square. The model was validated by the Hosmer-Lemeshow test and by these validation measures: sensitivity, specificity, and positive and negative predictive value. RESULTS: We analyzed data from 542 women. Parity (aOR = 1.66, 95% confidence interval [CI] 1.1-2.54), cervical dilation (aOR = 3.33, 95%CI 2.04-5.44), and gestational age (aOR = 1.44, 95%CI 1.21-1.72) were independent predictors of spontaneous delivery during the first 24 hours. A cross validation procedure showed that the calculator had a good accuracy (68%). CONCLUSIONS: A simple calculator based on maternal age, parity, gestational age, cervical dilatation, effacement and station, can accurately predict the chances of delivery within 24 hours of membrane sweeping. This may assist physicians better counseling of women regarding the likelihood of successful membrane sweeping.

The predictive role of CA-125 in the management of tubo-ovarian abscess. A retrospective study.

OBJECTIVE: Tubo-ovarian abscess (TOA) is a well-established sequel of acute pelvic inflammatory disease (PID). While as up to 25% of women will experience conservative treatment failure, the factors associated with treatment failure are not clearly-established, and the role of Cancer antigen 125 (CA-125) is under-studied. We aim to evaluate the role of CA-125 in the conservative management of TOA. STUDY DESIGN: A retrospective cohort study conducted at tertiary university-affiliated hospital during 2007-2018. Ninety one patients were diagnosed with a TOA and underwent a trial of conservative management with intravenous antibiotics. Patients who eventually underwent surgical intervention were compared with patients managed conservatively. RESULTS: Overall, 39/91 (42.8%) underwent an invasive intervention subsequent to failed antibiotic treatment. Patients who experienced conservative treatment failure had higher medians of inflammatory markers as CRP (15.7 vs. 10.8 mg/L, p = 0.02), WBC count (14.2 vs. 12.4 1,000/mm3, p = 0.04) and platelet count (374 vs. 295 109/L, p = 0.04) at admission. Higher levels of CA-125 at admission were found in those who required an invasive intervention (57 vs. 30 U\ml, p = 0.02) as well. The largest diameter of TOA at admission was higher in those who required an invasive intervention as compared to those who were successfully treated conservatively (75 mm vs. 57 mm, p = 0.01). CA-125 level was found to be the only independent factor associated with conservative treatment failure (OR; 95% confidence interval [CI], 1.27, 1.08-1.48, p = 0.03). CONCLUSION: Elevated CA-125 serum levels were found to be associated with failure of conservative parenteral antibiotic therapy for TOA. This finding should be better evaluated in a prospective manner.

Anatomical Outcome and Patient Satisfaction After Laparoscopic Uterosacral Ligament Hysteropexy for Anterior and Apical Prolapse.

OBJECTIVES: The aim of this study was to determine anatomical and clinical cure, as well as patient satisfaction in uterine-preserving laparoscopic uterosacral ligament suspension (LUSLS) in women with anterior and apical prolapse. METHODS: This was a retrospective cohort study including all women who underwent LUSLS for anterior and apical prolapse between January 2012 and December 2015 at a tertiary-care university hospital. All women had LUSLS hysteropexy and anterior colporrhaphy. Pre- and postoperative pelvic organ prolapse quantification (POP-Q) measurements were taken. Prolapse symptoms were queried via standardized history. Patient satisfaction was measured by the Patient Global Impression of Improvement (PGI-I). RESULTS: Fifty-three women underwent the procedure during the study period. Follow-up data were available for 48 women. The mean preoperative POP-Q Ba point was 2.7 ± 1.6 and C point was -0.8 ± 2.8. At a mean follow-up of 17.5 ± 16.0 months with a median of 12 months (range, 1-54 months), there was a significant improvement of POP-Q points Ba, C, and Bp (P < 0.001 for all comparisons). Anatomical cure, defined as no prolapse of any POP-Q point at or below 1 cm above the hymen (-1), was 85.4%. Clinical cure, defined as a composite outcome of no prolapse outside the hymen, C point above total vaginal length/2, no prolapse symptoms, and no need for further treatment, was 95.8%. At a mean of 22.2 ± 12.4 months postoperatively, patient satisfaction was high, with 95.5% stating their condition was very much better (PGI-I-A) or much better (PGI-I-B). CONCLUSION: Laparoscopic uterosacral ligament suspension is a valid uterine-preserving option for women with anterior and apical prolapse, with high anatomical and clinical cure rates and patient satisfaction.

Fetal macrosomia as a risk factor for shoulder dystocia during vacuum extraction.

OBJECTIVE: Vacuum extraction of a macrosomic fetus is considered a risk factor for shoulder dystocia (SD). We evaluated maternal and fetal outcomes following vacuum extraction of macrosomic infants. METHODS: A retrospective cohort study conducted in two large teaching hospitals. All deliveries of macrosomic infants by vacuum extraction and vaginal delivery were compared. The primary outcome measure was SD. Secondary outcome measures were severe perineal lacerations and postpartum hemorrhage. For statistical analysis, we used McNemar's test and χ2 or Fisher's exact tests. Odds ratios were analyzed via a logistic regression model. RESULTS: From 2003 to 2013, there were 6019 (5.45%) deliveries of macrosomic fetuses, and 230 (0.21%) were delivered by vacuum extraction. There were 23 (10%) and seven (3.04%) cases of SD in the study and control groups, respectively. The risk of SD was significantly higher in the study group (p > 0.05). We found a significant association between SD and vacuum delivery [p = 0.003; OR = 3.54 (95% CI: 1.49-8.42)]. The composite adverse neonatal outcome rate was 6.5% (15/230) and 1.7% (4/230) in the study and control groups, respectively (p = 0.009). CONCLUSION: Vacuum extraction of a macrosomic infant is a risk factor for shoulder dystocia but not for postpartum hemorrhage or severe vaginal tears.