14 CLINICAL STUDIES

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Selection bias limits the generalization of these findings because the type of participants in a city or

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a country could be different with other cities or countries and could be related to descent diversities.

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A total of 79 participants had been referred to the urology clinics in Rasht. Participants with idiopathic infertility in the age range of 25–40 years with normal arousal function were included in the study. Idiopathic infertility is defined as the lack of an obvious cause for couples' infertility and women's inability to get pregnant after at least 12 cycles of unprotected intercourse or after six cycles in women aged > 35 years for whom all standard evaluations are normal. Unexplained infertility is a condition when standard infertility testing has not found a cause for a couple's or a woman's inability to get pregnant. Some reproductive physicians hold that a diagnosis of unexplained infertility is a nondiagnosis.

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Estimations indicate that 15%–30% of couples with infertility are diagnosed as having unexplained infertility, making it one of the most common causes of infertility. The variation in the estimated percentage of unexplained infertility is due to the fact that experts do not agree on what should constitute “standard infertility testing.” Testing can vary according to the individual's situation and physician's testing protocols. These may be performed in addition to a physical examination and review of medical and sexual history. Both partners may have unexplained fertility problems. The primary outcomes of the study were seminal parameters that were measured by automated sperm quality analyzers (SQA IIC-P, USA).

Authors and Affiliations

Study variables included age, sperm count, semen volume, pH, abnormal morphology, semen viscosity, liquefaction time, and sperm motility. Both participants and questioners did not have any information about the study groups. Drugs were classified as follows: placebo (Marham Daru Company) and sildenafil citrate (Marham Daru Company). Drugs were placed into two separate envelopes and randomly classified. Participants were assigned to two Groups: A (n = 40) and B (n = 39). In Iran, sildenafil is the most prescribed medication to treat male sexual problems.

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To date, different studies have been reported that sildenafil could be useful to sperm function.

7. Tadliq

[20] The condensation, viscosity, and appearance of specimens were evaluated by automated (SQA IIC-P, USA). Sperm concentration and count were calculated by automated (SQA IIC-P, USA). Sperm morphology was evaluated by eosin-hematoxylin staining. Sperm motility and kinetic were evaluated after 30 min at room temperature. Then, intervention and control groups were replaced after the washout period.

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Participants underwent a semen analysis approximately 1 week before receiving the first dose of sildenafil and placebo. Data of participants were extracted and then analyzed using SPSS statistical software version 16 IBM SPSS software, USA. Independent t-test and pairwise t-test were conducted. If the variables did not have normal distribution, nonparametric Mann–Whitney and Wilcoxon tests were used (P < 0.05). In the current study, 237 specimens from 79 participants were studied.

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The mean age of participants was 34 ± 5 years. The mean sperm counts in 79 patients were approximately 43.94 × 106 per ejaculation. Table 1 shows semen analysis in 79 participants at the baseline double-blind placebo-controlled, cross-over clinical trial on the administration of 50 mg sildenafil tablet Table 1. Conversely, Tables 2 and 3 show semen viscosity and liquefaction time analysis in Groups A and B, including 39 and 40 participants, after double-blind placebo-controlled, cross-over clinical trial pre-post administration of 50 mg sildenafil and placebo tablets (P > 0.05) [Tables 2 and 3]. According to the results, 50 mg sildenafil did not have a sufficient effect on sperm motility and sperm viscosity at the baseline (P > 0.05). The current study showed that sildenafil had no significant effect on semen parameters.

5.1 Mortality with Pediatric Use

The comparison of semen quality and liquefaction time between sildenafil and placebo groups at phase II As shown in Table 4, 50 mg sildenafil and placebo tablets had no effects on ejaculatory fluid volume, semen viscosity, semen pH, sperm number, and sperm motility after sildenafil administration in both Groups (A and B) at Phase I (P > 0.05) [Table 4]. Moreover, no significant difference was shown between the volume of the ejaculatory fluid, semen viscosity, semen pH, number of sperms, baseline sperm motility, and sperm motility after administration in both Groups (A and B) at Phase II (P > 0.05) [Table 5]. Effect of sildenafil and placebo on the changes of ejaculatory fluid volume, semen viscosity, semen pH, sperm count, sperm motility of patients at phase I Effect of sildenafil and placebo on the changes of ejaculatory fluid volume, semen viscosity, semen pH, sperm count, sperm motility of patients at phase II In this randomized, double-blind, controlled cross-over clinical trial, 79 participants were treated with 50 mg sildenafil and placebo. The mean age of patients was 34 ± 5 years, and the sperm number was 43.94 ± 64.06 (million) per ejaculation [Table 1]. This study demonstrated that 50 mg sildenafil tablet did not have any effect on semen viscosity and liquefaction time in Groups A and B (P > 0.05) [Tables 2 and 3].

What is sildenafil used for?

The results show that 50 mg sildenafil tablet had no effects on ejaculatory fluid volume, semen viscosity, semen PH, sperm number, baseline sperm motility, and sperm motility after sildenafil administration in both Groups (A and B) at Phase I (P > 0.05) [Table 4]. We also found that there was no significant difference in ejaculatory fluid volume, semen viscosity, semen PH, sperm number, baseline sperm motility, and sperm motility after sildenafil administration in both Groups (A and B) at Phase II (P > 0.05) [Table 5]. showed that sildenafil has no effect on sperm count. [7,10,11] It was argued that PDE5 inhibitors increase secretory function. It is associated with increase in the serum insulin-like peptide concentrations in the sperm.

What are the serious side effects of sildenafil?

[6] The studies showed that consumption of 100 mg sildenafil would increase sperm motility. [11,22,23,24] Studies showed that Type 4 and Type 5 inhibitors improve sperm motility. [13] Researchers found that women sildenafil a low sildenafil dose had no effect on sperm motility. also confirmed the positive effects of sildenafil on sperm motility in infertile patients. [11] Moreover, we reported no significant change in morphology, viscosity, and liquefaction time of semen after sildenafil administration compared with placebo. Currently, PDE5 enzyme inhibitors, particularly sildenafil, are the first and most popular treatment options for men with impotence.

  • Sildenafil tablets LP 100 mg are used to treat erectile dysfunction in men.
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However, the results of this study show that oral sildenafil citrate

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does not have any significant effect on any of the semen parameters.

7.1 Nitrates

First, this was a single-center study; therefore, the results require further investigation. Second, the erectile and ejaculatory functions of participants were not measured. Third, the sample size of this study was small, and there was low power to detect an effect from sildenafil. Finally, patients only used one dose of sildenafil (50 mg) for evaluation. Hence, further studies seem to be required in this field. It is recommended that more studies should be conducted with a

  • Avoid using sildenafil tablets LP 100 mg with recreational drugs.
  • Seek immediate medical attention if you experience allergic reactions.
  • Talk to your healthcare provider about any side effects experienced.

larger sample size, higher sildenafil doses (≥100 mg), and longer follow-up period.

5.4 Visual Loss

In Phase I, participants in Group A received sildenafil (50 mg) and placebo after the washout period, whereas participants in Group B received placebo and then sildenafil after the washout period. In Phase II, participants in Group A received placebo and then sildenafil after the washout period, and participants in Group B received sildenafil and then placebo after the washout period. The participants in each group received 50 mg of sildenafil in a single dose, and the washout period took a week for each group. The clinical trial registration number in the “Iranian Registry of Clinical Trial” was IRCT201611291853N12. Ethical approval for this study was obtained from Guilan University of Medical Sciences (approval number: IR.

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Written informed consent was obtained from all subjects before the study. Participants had not ejaculated, smoked, and consumed caffeine for sildenafil 200 mg 3 days before receiving the drugs. Semen specimens were collected 1 h after consumption of drugs and evaluated according to the World Health Organization guidelines. [21] To transport the semen, we required the participants to prepare the sperm sample on-site (laboratory) to ensure that the best possible sperm sample was obtained. If the samples were collected outside the clinic, the participants needed to transfer them to the laboratory within 1 h after ejaculation.

Corresponding author

We advised participants that the semen samples must be kept as close to body temperature as possible. Moreover, the semen samples were stored in the container upright in a plastic bag, with the lid securely tightened. The specimen was not placed in any purse, pocket, or briefcase. The semen samples were stored at 25°C in the laboratory. The semen parameters were measured by automated (SQA IIC-P, USA). We thank our colleagues from Urology Research Center, Guilan University of Medical Sciences, who provided insight and expertise that greatly assisted the study although they may not agree with all interpretations/conclusions of this paper.

The bottom line

This is consistent with Purvis et al., who found that sildenafil had no significant effect on morphology, viscosity, and liquefaction time of semen after sildenafil administration. showed that sildenafil (100 mg) did not change sperm parameters of healthy patients and indicated that potential use of medication can be helpful in assisted reproductive techniques when ED temporarily occurs. reported that 125, 250, and 750 ng/mL sildenafil did not significantly change motility and viability of human sperm. also reported that the drug practically did not affect semen parameters and its volume and acidity. The findings of this study had some limitations.