Search Results (5)

Objectives: This research aimed to study the effect of 15mcg/day of follitropin delta on normo-responding women. Methods: A single-center, open-label, matched case–control pilot trial was carried out from September 2021 to June 2022. In this trial, normo-responding oocyte donors were given 15 mcg/day of follitropin delta or 225 IU/day of follitropin alfa, as well as medroxyprogesterone acetate for pituitary suppression during the cycle. The main outcome measured was the number of oocytes retrieved. Results: A fixed dose of 15 mcg/day of follitropin delta for ovarian stimulation in normo-responders achieved an average of 17 oocytes retrieved. No differences were observed vs. 225 IU/day of follitropin alfa in the number of oocytes [17.8 ± 7.8 vs. 18.5 ± 7.7, respectively, p = 0.156], the number of metaphase II oocytes [13.5 ± 6.9 vs. 15 ± 6.3, p = 0.105], the fertilization rates (71.1% vs. 72.9%, p = 0.523), the number of usable blastocysts (4.9 ± 2.4 vs. 4.5 ± 2.5, p = 0.466), and the implantation rate (64% vs. 57%, p = 0.575). In the follitropin delta group, the duration of the stimulation was significantly shorter (9.4 ± 1.2 vs. 10.9 ± 1.2, p < 0.01), and the overall gonadotropin intake was lower. There were no clinically relevant differences between treatment groups regarding the safety profile. Global patient satisfaction with the follitropin delta ovarian stimulation was very high (7.7 ± 2.2). Conclusions: A daily dose of 15 mcg of follitropin delta may provide a similar ovarian response to 225 IU/day of follitropin alfa; aiming to retrieve 17 oocytes in normo-responders undergoing progestin-primed ovarian stimulation, it could reduce gonadotropin intake by reducing the duration of the stimulation cycle, with a possible high patient satisfaction level. Full article

Ovarian hyperstimulation syndrome (OHSS) is the main severe complication of ovarian stimulation for in vitro fertilization (IVF) cycles. The aim of the current study was to identify the interventions for the prevention of and reduction in the incidence and severity of OHSS in patients who undergo IVF not included in systematic reviews with meta-analyses of randomized controlled trials (RCTs) and assess and grade their efficacy and evidence base. The best available evidence for each specific intervention was identified, analyzed in terms of safety/efficacy ratio and risk of bias, and graded using the Oxford Centre for Evidence-Based Medicine (CEBM) hierarchy of evidence. A total of 15 interventions to prevent OHSS were included in the final analysis. In the IVF population not at a high risk for OHSS, follitropin delta for ovarian stimulation may reduce the incidence of early OHSS and/or preventive interventions for early OHSS. In high-risk patients, inositol pretreatment, ovulation triggering with low doses of urinary hCG, and the luteal phase administration of a GnRH antagonist may reduce OHSS risk. In conclusion, even if not supported by systematic reviews with homogeneity of the RCTs, several treatments/strategies to reduce the incidence and severity of OHSS have been shown to be promising. Full article

Follitropin delta (Δ) is a recombinant human follicle-stimulating hormone (rFSH), like natural human FSH, that can stimulate the development and growth of multiple follicles. Treatment with Follitropin-Δ may cause mild to severe adverse reactions, such as the risk of developing ovarian hyperstimulation syndrome, resulting in nausea, vomiting and diarrhea, weight loss, respiratory difficulty, stomach swelling and discomfort of the pelvic area, headaches, and fatigue. To date, the effects of a Follitropin-Δ overdosage are unknown, and no data are reported in the scientific literature or in the drug data sheet. Therefore, this study aimed to describe the effects of Follitropin-Δ overdosages in poorly responding women who underwent IVF cycles. This is a descriptive case series of four nulligravid, poorly responding patients, two of whom made requests for fertility preservation. Four poorly responding patients who were prescribed 20.0 µg/day of Follitropin-Δ for three consecutive days wrongly injected the total cartridge of 72 µg Follitropin-Δ every day. After the incorrect injection of Follitropin-Δ, the patients continued their controlled ovarian stimulation and underwent vaginal ovarian pick up. The analyzed patients had no side effects or adverse reactions. The evaluations reported in this case series showed that the accidental use of 72 µg/day of Follitropin-Δ for three days did not cause side effects or adverse reactions in poor responders. Full article

Background: Follitropin delta is the third recombinant human follicle-stimulating hormone (r-hFSH) expressed in a host cell line of human fetal retinal origin that currently emphasizes that the actual tendency of administration is a personalized dosing algorithm based on the anti-Müllerian hormone (AMH) and body mass index (BMI) for ovarian stimulation. Methods: In this context, we aimed, in the present manuscript, to gather all available data published between 2018–2022 regarding the co-administration and administration of follitropin delta and the clinical outcomes reported following an in vitro fertilization (IVF). Results: Follitropin delta is non-inferior in contrast to its previously launched agents for ovarian stimulation, enhancing a similar-to-superior response reflected by both the reproductive and pregnancy outcomes in parallel with a low risk of ovarian hyperstimulation syndrome (OHSS), being well tolerated. The body weight and AMH level are factors that may influence the outcome in a patient. Despite controversy and results that refute these arguments on several occasions, follitropin delta exceeds the benefits of conventional dosing with either follitropin alfa or follitropin beta. Thus, all post hoc, derived analyses and subsets of patients that participated in subsequent studies support this statement. Conclusions: Despite the relatively limited spectrum of data in the current literature, most authors brought potent proof, supporting the subsequent use of this drug depending on the patient’s profile and overcoming ethnic-related limitations. Although others contradict these observations, this topic and drug possess substantial potential, which is why additional studies are mandatory to fill the existing gaps in our knowledge and expand these experiences at a larger scale supported by the obtained reproductive and clinical outcomes that clearly indicate an overcoming of all limitations. Full article

Background and objectives: The latest reports suggest that follitropin delta is a highly efficient recombinant human follicle-stimulating hormone (r-hFSH) that became a part of the current assisted reproductive technologies (ARTs). Therefore, the present study aims to assess a series of parameters (follicles, oocytes, and embryos) and further by the outcomes in women following the administration of follitropin delta. Materials and methods: This observational study included 205 women. They were aged between 21 and 43 years (mean 33.45) and an anti-Müllerian hormone (AMH) level ranging from 0.11 to 16.00 ng/dL (mean 2.89). Results: In accordance with the established methodology and following the centralization of data, a total of fifty-eight pregnancies (28.29%) were achieved; forty-five (36.88%) were achieved in women under 35 years and thirteen (15.66%) in women above 35 years. These figures are positively correlated with women’s age considering that the number of follicles >18 mm, oocytes fertilized and embryo(s) varies among groups. Regarding the interest parameters, we noted n = 1719 follicles > 18 mm, n = 1279 retrieved oocytes, and n = 677 embryos at day 3. On the other hand, the following figures have been registered in women above 35 years: 814–follicles > 18 mm, 612 oocytes retrieved and 301 embryos at day 3. During this study, we registered only three cases of abortions (n = 1–0.81% in women under 35 years and n = 2–2.40% in women above 35 years). Nine pregnancies (7.37%) were stopped from evolution in females under 35 years, and twelve pregnancies (n = 8–6.55% in women under 35 years, while n = 4 in women above 35 years) were unsuccessful. A twin pregnancy has been confirmed (1.20%) in women above 35 years, six ongoing pregnancies (4.91%) in those under 35 years, and two in both groups (one per group–n = 1–0.81%, and 1.20%–n = 1) in which we did not know the exact result were registered at the end of the established studied interval. However, there were also situations in which the treatment cause an over-reactivity or had no effect; n = 2 were non-responders, and n = 1 exhibited moderate ovarian hyperstimulation syndrome (OHSS). Conclusions: Based on our results, we strongly encourage the use of this recombinant gonadotropin on a much larger scale. Full article