[Clinical efficacy of Xuanju compound capsule combined with urofollitropin in the treatment of patients with idiopathic oligoasthenozoospermia].

OBJECTIVE: To evaluate the therapeutic effects of Xuanju compound capsule combined with urofollitropin (uFSH) in the treatment of idiopathic oligoasthenozoospermia. METHODS: From June 2022 to June 2023, patients with idiopathic oligoastheospermia were enrolled in this study, and divided into trail group (Xuanju compound capsule combined with urofollitropin tablets, n=53) and control group (urofollitropin tablets, n=61) according to the difference in treatment. Treatment methods: Xuanju compound capsule, 3 pills, three times a day; Urofollitropin, 75IU, one times three day. The curses of treatments for control group and trail group is 12 weeks. In order to evaluate the therapeutic effects of control group and trial group, semen volume, sperm concentration, progressive sperm ratio (PR), peripheral serum sex hormone, liver functions were analyzed before and after treatment for two times. RESULTS: Compared with the baseline, the semen volume and liver function were not significantly changed after the treatment in control group and trial group. However, sperm concentration, PR, testosterone (T) levels, follicle stimulating hormone (FSH) levels, and luteinizing hormone (LH) levels were significantly unregulated after the treatment in control group and trial group. More importantly, compared to control group, sperm concentration, PR, T leves, FSH levels, LH levels, and T/E2 ratio of trial group were further enhanced after the treatment, which were statistically significant (P < 0.05). CONCLUSIONS: Xuanju compound capsule combined with urofollitropin tablets could significantly improve the semen quality, up-regulate the testosterone levels and T/E2 ratio in patients with idiopathic oligoasthenozoospermia.

Testosterone levels after treatment with urofollitropin in infertile patients with idiopathic mild reduction of testicular volume.

INTRODUCTION: A reduction of testicular volume (TV) represents an important clinical sign, which may hide sperm abnormalities and predispose to hypogonadism. AIM: The primary purpose of this study was to evaluate the serum levels of total testosterone after treatment with urofollitropin in selected patients with male infertility and idiopathic mild reduction of testicular volume. METHODS: In this 1-year-long prospective design, patients with abnormal sperm parameters, mild reduction in TV (8-12 mL) and normal gonadotropin, and total testosterone (TT) serum levels were recruited in this study. Patients treated for 4 months with urofollitropin were included in group A, those treated with intracytoplasmatic sperm injection due to a female-factor infertility were included in group B. Hormone values, sperm parameters, and TV were detected at baseline (T0), after 4 (T1) and 12 months (T2) in group A and at T0 and T2 in group B. RESULTS: Group A (n = 80) showed increased follicle-stimulating hormone (FSH) at T1 and sperm morphology at T1 and T2 compared to T0 (all p < 0.05). Group B (n = 50) had lower TT and higher FSH levels at T2 compared to T0 (all p < 0.05). At T2, TT, VT, total sperm count, progressive motility, total motility, and sperm morphology were higher in group A compared to group B (all p < 0.05). CONCLUSION: Reduced TV may predispose to infertility and hypogonadism. FSH treatment may improve Sertoli and Leydig cell function and prevent the development of hypogonadism.

Effectiveness of highly purified urofollitropin treatment in patients with idiopathic azoospermia before testicular sperm extraction.

INTRODUCTION: Recent evidences demonstrated that male factor alone is responsible for about 30% cases of infertility. Human follicle-stimulating hormone (hFSH) has been introduced to increase sperm concentration, spermatogonial population, or both natural or assisted pregnancy rates (PRs) in oligozoospermic subjects with normal concentrations of gonadotropins. METHODS: Fifty infertile men affected by idiopathic azoospermia were enrolled in this study, after undergoing medical history, physical and clinical examination, baseline semen parameters and hormonal plasma concentrations. Inclusion criteria were infertility for at least 2 years, idiopathic azoospermia, FSH <12 mIU/ml. Twenty-five patients were allocated to treatment with hFSH three times/week per 3 months (Fostimon), and 25 patients underwent just testicular sperm extraction (TESE) without medical treatment. All patients underwent, after 3 months, assisted reproduction techniques (ARTs) with TESE. The primary outcome was represented by the differences in the sperm retrieval rate (SRR) between groups, while the secondary outcomes were the differences in PR and fertilization rate (FR). RESULTS: We observed a PR of 15% (3/25) and 28% (7/25) in control and treated group, respectively. SRR after medical treatment and ART was 24% (6/25), while in the control group was 12.5% (2/25). The sperm in the ejaculate of five patients (20%) after medical treatment exhibited a mean concentration of 0.9 million/ml and a mean motility of 12%. The FR was significantly greater in the treatment group with respect to the control group, 30% and 20%, respectively. CONCLUSIONS: FSH treatment showed greater efficacy rather than control by increasing the rate of PR and FR in azoospermic patients who underwent TESE.

Recombinant versus highly-purified, urinary follicle-stimulating hormone (r-FSH vs. HP-uFSH) in ovulation induction: a prospective, randomized study with cost-minimization analysis.

BACKGROUND: Both recombinant FSH (r-FSH) and highly-purified, urinary FSH (HP-uFSH) are frequently used in ovulation induction associated with timed sexual intercourse. Their effectiveness is reported to be similar, and therefore the costs of treatment represent a major issue to be considered. Although several studies about costs in IVF have been published, data obtained in low-technology infertility treatments are still scarce. METHODS: Two hundred and sixty infertile women (184 with unexplained infertility, 76 with CC-resistant polycystic ovary syndrome) at their first treatment cycle were randomized and included in the study. Ovulation induction was accomplished by daily administration of rFSH or HP-uFSH according to a low-dose, step-up regimen aimed to obtain a monofollicular ovulation. A bi- or tri-follicular ovulation was anyway accepted, whereas hCG was withdrawn and the cycle cancelled when more than three follicles greater than or equal to 18 mm diameter were seen at ultrasound. The primary outcome measure was the cost of therapy per delivered baby, estimated according to a cost-minimization analysis. Secondary outcomes were the following: monofollicular ovulation rate, total FSH dose, cycle cancellation rate, length of the follicular phase, number of developing follicles (>12 mm diameter), endometrial thickness at hCG, incidence of twinning and ovarian hyperstimulation syndrome, delivery rate. RESULTS: The overall FSH dose needed to achieve ovulation was significantly lower with r-FSH, whereas all the other studied variables did not significantly differ with either treatments. However, a trend toward a higher delivery rate with r-FSH was observed in the whole group and also when results were considered subgrouping patients according to the indication to treatment. CONCLUSION: Considering the significantly lower number of vials/patient and the slight (although non-significant) increase in the delivery rate with r-FSH, the cost-minimization analysis showed a 9.4% reduction in the overall therapy cost per born baby in favor of r-FSH.

Prospective, randomized study comparing highly purified urinary follicle-stimulating hormone (FSH) and recombinant FSH for in vitro fertilization/intracytoplasmic sperm injection in patients with polycystic ovary syndrome.

In a randomized study comparing purified urinary FSH with recombinant FSH for IVF/intracytoplasmic sperm injection in patients with polycystic ovary syndrome, there was no significant difference between the mean total dose of FSH used, duration of stimulation, number of retrieved oocytes, number of mature oocytes, number of embryos transferred, or the ongoing pregnancy rate between the two groups. However, there were significantly more fertilized oocytes, a higher fertilization rate, more top-quality embryos, and more cryopreserved embryos in the urinary FSH group.

Clinical efficacy of highly purified urinary FSH versus recombinant FSH in volunteers undergoing controlled ovarian stimulation for in vitro fertilization: a randomized, multicenter, investigator-blind trial.

OBJECTIVE: To compare the efficacy of highly purified human urinary follicle stimulating hormone (HP-hFSH) versus human recombinant follitropin-alpha (rFSH) in volunteers undergoing controlled ovarian stimulation for IVF. DESIGN: A randomized, controlled, investigator-blind trial. SETTING: Four assisted reproductive technology centers. PATIENT(S): One hundred fifty-two IVF patients. INTERVENTION(S): Volunteers, aged 18-39, were randomized to HP-hFSH (n = 76) versus rFSH (n = 76) at a starting dose of 300 IU in down-regulated cycles. MAIN OUTCOME MEASURE(S): Number of oocytes, clinical pregnancy rate, and live birth rate with HP-hFSH versus rFSH. RESULT(S): The total IU of gonadotropin used did not differ between the two groups. There was no difference in number of oocytes retrieved with HP-hFSH (mean = 16.3) compared with rFSH (mean = 17.1), confidence interval (CI) of difference = -3.79 to +2.18. Clinical pregnancy rate, as defined by the presence of a gestational sac, was 48.7% (CI = 37.0%-60.4%) with HP-hFSH versus 44.7% (CI = 33.3%-56.6%) with rFSH (CI of difference = -11.9% to +19.8%). Live birth rate was 38.2% (29 of 76) in both groups (CI = 27.2%-50.0%), for a difference between groups of 0.0% (CI of the difference = -15.4% to +15.4%). CONCLUSION(S): There were no statistically significant differences in mean oocyte number, clinical pregnancy rate, or live birth rate between HP-hFSH versus rFSH.

Efficacy of a combined protocol of urinary and recombinant follicle-stimulating hormone used for ovarian stimulation of patients undergoing ICSI cycle.

PURPOSE: To evaluate the efficacy of using both urinary and recombinant FSH in a combined protocol for ovarian stimulation in an IVF treatment program. METHOD: A total of 119 infertile couples undergoing ICSI treatment were randomized prospectively in this study. After a standard down-regulation with GnRH analogue, the patients were randomized in 2 groups 58 received combined urinary and recombinant FSH, starting with uFSH and then rFSH, and 61 controls received only recombinant FSH. RESULT(S): Pregnancy and implantation rates were significantly higher in the combined uFSH/rFSH group than the control (rFSH) group (43.9% vs 22.1% and 27.5% vs 13.2% respectively). Metaphase II oocyte and grade 1 embryos were significantly higher in favour of combined uFSH/rFSH group than the recombinant FSH group. CONCLUSION(S): This study shows that using a combination of both urinary and recombinant FSH for ovarian stimulation improves oocyte maturity and embryo cleavage, and increases pregnancy and implantation rates.

¿Hay diferencias entre las gonadotropinas disponibles para la estimulación ovárica en técnicas de reproducción asistida? / Are there any differences in the gonadotrophins available for ovarian stimulation in assisted reproduction techniques?

En el mercado español se dispone de diversas gonadotropinas utilizadas en los programas de reproducción asistida. El objetivo de esta revisión es determinar las diferencias entre ellas y establecer las ventajas y los inconvenientes de cada una en base a su origen, seguridad y eficacia clínica. Desde el punto de vista técnico, las gonadotropinas recombinantes presentan ventajas técnicas y mayor pureza, actividad específica y homogeneidad entre lotes. Desde el punto de vista de la seguridad, aunque hay diferencias claras en el origen, y por tanto en los riesgos de transmisión de enfermedad infecciosa, todas las gonadotropinas disponibles han mostrado ser seguras. Es desde el punto de vista de la eficacia donde es más difícil establecer diferencias. Muchos de los estudios disponibles son pequeños y no siempre los parámetros de evaluación han sido comparables. La mayoría de los estudios no han podido establecer diferencias, por lo que existen en la literatura científica diversos metaanálisis que tratan de responder básicamente a dos aproximaciones: saber si las FSH recombinantes (FSHr) son mejores que las urinarias y si la hormona recombinante es mejor que la gonadotropina menopáusica humana. Los datos no permiten demostrar que las urinarias o la hMG, solas o en combinación, sean más eficaces que la FSHr, mientras que, por el contrario, las recombinantes han mostrado ser más eficaces que las urinarias purificadas agrupadas (AU)

In Spain, several different gonadotrophins are available for assisted reproductive techniques. The present review aims to determine the differences between these gonadotrophins and to establish the advantages and limitations of each in terms of their origin, safety, and efficacy. From the technical point of view, recombinant gonadotrophins have enhanced purity, specific activity and greater consistency. From the safety point of view, there are clear differences in the origin and manufacturing process and consequently in the risk of infectious diseases; however, to date, all gonadotropins have been demonstrated to be safe. Differences in efficacy are more difficult to establish. Many trials have compared preparations but, because of their small size and variations in study design, the results have been variable. Most of the studies have failed to detect any differences and consequently several meta-analyses have aimed to determine whether recombinant follicle- stimulating hormone (FSH) gonadotrophins are preferable to urinary-derived FSH and whether recombinant hormone is superior to human menopausal gonadotropin (hMG). The published results do not demonstrate that urinary-derived FSH or hMG, alone or when data are pooled, are more effective than recombinant FSH. In contrast, recombinant gonadotrophins have been shown to be more effective than urinary- derived gonadotrophins as a whole (AU)