.

Thrombophilia might be the essential pathogenetic mechanism of thromboembolism associated with pregnancy. Venous thromboembolism during or after assisted reproductive technologies is predicted to emerge due to increased number of women undergoing this technique. Low molecular weight heparins was effective for preventing recurrent thromboembolism and severe obstetric complications. Women with personal or family history of thromboembolism or with history of obstetric complications should be screened for thrombophilia.

Introduction. The efficacy and safety of biosimilar follitropin alpha have been demonstrated in randomized, blinded, prospective clinical trials of phases I and III. Unfortunately, there is a gap between the clinical trials and real clinical practice data. The real-world patient data helps to create an evidence-based background for successful implementation of a medicine at everyday practice in a nonselected population.Aim: to investigate the efficacy of follitropin alpha biosimilar therapy (Primapur®) in nonselected real-world population.Materials and Methods. A retrospective observational anonymized cohort study of follitropin alpha biosimilar as a pre-filled pen injector with a dose adjustment of 5 IU (Primapur®), aimed at investigate its efficacy and safety in a nonselected population with indications to assisted reproductive technologies (ART). The ovarian stimulation (OS) protocols included: monotherapy protocols with using only Primapur®; mixed protocols (recombinant and urinary-derived gonadotropins); short protocols with using antagonists gonadotropin-releasing hormone (GnRH) antagonist and long protocols with GnRH agonists. The stimulation protocols analyzed where Primapur® was applied for at least 5 days.Results. The overall clinical efficacy of ovarian stimulation cycles (N = 5484) was: oocytes retrieved – 9.5 ± 7.2, mature (MII) – 6.8 ± 6.6, fertilized (2PN) – 6.1 ± 5.8, clinical pregnancy per ET (PR) – 38.4 %. Mixed gonadotropin protocols (N = 2625) vs. monotherapy with Primapur® (N = 2859): oocytes retrieved – 8.6 ± 6.8 vs. 10.3 ± 7.4 (p < 0.001), mature (MII) – 6.7 ± 6.2 vs. 7.7 ± 6.9 (p < 0.001), fertilized (2PN) – 5.8 ± 5.2 vs. 7.2 ± 6.2 (p < 0.001). There were statistically significant differences between oocyte yields in mixed vs. monotherapy protocols due to subgroup differences, including age, body mass index (BMI) and IVF/ICSI attempts. No statistically significant differences were found for PR: 39.3 % vs. 37.6 % (p = 0.314). Monotherapy protocols with GnRH antagonist OS (N = 2183) vs. GnRH agonist (N = 676) revealed: oocytes retrieved – 10.5 ± 7.5 vs. 9.6 ± 7.0 (p = 0.032), mature (MII) – 7.6 ± 6.9 vs. 6.7 ± 5.7 (p < 0.001), fertilized (2PN) – 7.3 ± 6.3 vs. 5.7 ± 5.0 (p < 0.001). There were statistically significant differences between BMI and IVF/ICSI attempts. No statistically significant differences were found for PR: 37.9 % vs. 35.9 % (p = 0.482). All medicines were well tolerated and no serious adverse reactions were reported.Conclusion. This was the largest retrospective observational study conducted in the field of fertility in Russia and involved 5484 ovarian stimulation protocols at 35 IVF clinics. The obtained results demonstrated similar clinical efficacy for follitropin alpha biosimilar Primapur® in different OS protocols in real clinical practice.

We have accumulated my own experience of management pregnant women with COVID-19 after assisted reproductive technologies (ART) receiving low molecular weight heparins (LMWH). All women suffered COVID-19 in mild form without respiratory failure and gave birth to healthy children. Our observations correspond to the data of world literature. Therefore, we want to draw the attention of the editors and the readers to the positive role of LMWH in the control of COVID-19.