Efficacy of growth hormone supplementation with ultrashort GnRH antagonist in IVF/ICSI for poor responders; randomized controlled trial.

OBJECTIVES: To compare the ICSI-ET outcomes in poor responders who underwent ovarian stimulation by the ultrashort GnRH antagonist protocol with or without adjuvant GH injection. MATERIAL AND METHODS: This randomized controlled study was conducted at Al-Azhar University from December-2018 to June-2019 upon 156 participants. All patients received the same preparations. After randomization, in the study group, women have received GH 4 IU/day subcutaneous injection from the second day of the cycle stopped one day before ovum pickup. While in the control group, women have received subcutaneous saline in the same dosing as in the study group. After intervention, all procedures were the same in both groups. The main outcome measure was the clinical pregnancy rate. Statistical analysis was based on the intention-to-treat population. RESULTS: Both groups were comparable with regard their baseline characteristics (p-values > 0.05). Ovulation characteristics were comparable (p-values > 0.05). The level of E2 is significantly (p-value = 0.003) higher in the GH group. The oocyte retrieved number was significantly (p-value < 0.001) higher in the GH group 4.94 ± 1.77 than in the control group 3.74 ± 1.82. The mean number of MII oocytes was significantly (p-value < 0.001) higher in the GH group 3.3 ± 1.36 than in the control group 2.29 ± 1.24. Fertilization characteristics, implantation rate, pregnancy rate were comparable (p-values > 0.05). CONCLUSION: Despite the fact that this study showed no significant increase in the clinical and chemical pregnancy rates by the addition of GH to the ultrashort antagonist protocol in poor responders, the number of retrieved oocytes was significantly higher in the GH group. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03759301.

The impact of ultrasound-guided continuous serratus anterior plane block versus intravenous patient-controlled analgesia on the incidence and severity of post-thoracotomy pain syndrome: A randomized, controlled study.

OBJECTIVE: The aim of this randomized controlled trial was to evaluate U/S guided serratus anterior plane catheter block (SAPB) versus patient-controlled analgesia (PCA) on the emergence of post-thoracotomy pain syndrome (PTPS) after thoracotomies for thoracic tumours. METHODS: This trial included 89 patients with chest malignancies, scheduled for thoracotomy were randomly allocated into two groups: Group A "PCA-group N=44" receiving patient-controlled analgesia and group B "SAPB group N=45" where analgesia was provided by SAPB. The primary outcome measure was the assessment for the possible emergence of PTPS at 12 weeks. The secondary outcome measures were pain relief measured using visual analog scale (VAS) score, Quality of life was assessed using Flanagan Quality of Life Scale (QOLS) and Activity level was assessed using Barthel Activity of daily living (ADL) score. RESULTS: At week 8, PTPS incidence was significantly (p = .037) higher in the PCA group (45%) than in the SAPB group (24%) with a relative risk of 1.38 and 95% CI (1.01-1.9) while the incidence of PTPS at week 12 was significantly (p = .035) higher in the PCA group (43%) than in the SAPB group (22%) with a relative risk of 2.38 and 95% CI (1.23-4.57). The need for pain therapy in PTPS patients was significantly lower in the SAPB group (17.7%) than the PCA group (38.6%) (p = .028) at week 12. Pain intensity: VAS-R and VAS-D (pain scores at rest and with activity, respectively) was comparable (p > .05) between both groups at 6, 12, 18 and 24 hr, however VAS was significantly higher in the PCA group at week 8 (p = .046) and week 12 (p = .032) . Both groups were comparable regarding ADL and QOL scores (p > .05). CONCLUSION: Serratus anterior plane block is assumed to be a good alternative for post-thoracotomy analgesia following thoracotomies. The current work hypothesized that SAPB for a week postoperatively, may reduce the emergence of PTPS and may reduce the demand for pain therapy in those patients. SIGNIFICANCE STATEMENT: The current work hypothesized that SAPB for a week postoperatively, is a good loco-regional alternative for post-thoracotomy analgesia following thoracotomies for chest malignancies, it may reduce the emergence of PTPS and the demand for pain therapy in these patients.

Multicenter randomized controlled trial assessing the impact of a cervical traction maneuver (Amr's maneuver) on the incidence of postpartum hemorrhage.

OBJECTIVE: To assess the impact of a cervical traction maneuver (Amr's maneuver) used in conjunction with active management of the third stage of labor (AMTSL) on the incidence of postpartum hemorrhage (PPH). METHOD: The present multicenter randomized controlled trial was conducted in Cairo between March 1, 2016, and June 30, 2017. Women aged at least 18 years who had singleton pregnancies and were candidates for vaginal delivery were enrolled. After block randomization, AMTSL was performed for all participants. Following placental delivery, Amr's maneuver using cervical traction for 90 seconds was carried out in the study group. The primary outcome, incidence of PPH (>500 mL blood loss) within 6 hours of delivery, was compared between the study and control groups in an intention-to-treat analysis. RESULTS: There were 852 patients randomized to the study (n=426) and control (n=426) groups. The incidence of PPH was significantly lower in the study group compared with the control group (6 [1.4%] vs 19 [4.5%]; P=0.015). Absolute risk reduction of 3.1% (95% CI 0.8-5.6), relative risk reduction of 0.32 (95% CI 0.13-0.78), and number needed to treat of 33 (95% CI 129-18) were observed in the study group. CONCLUSION: Amr's maneuver was effective in decreasing the incidence of PPH. ClinicalTrials.gov Identifier: NCT02660567.