Vaginal Gel Research Articles

Reduction of obstetric injuries by increasing of the birth canal elasticity

The objective: to evaluate the therapeutic effect of a vaginal gel containing hyaluronic acid and decamethoxine for the prevention of obstetric injuries reduction of the birth canal during childbirth, as well as to improve the course of the postpartum period.Materials and methods. An analysis of the course of vaginal births in the fetal head presentation of 500 births that took place in the communal non-commercial enterprise «Kyiv City Maternity Hospital No. 2» during 2021–2022 was carried out. The main group included 250 pregnant women who were given a vaginal gel containing decamethoxine, sodium hyaluronate and lactic acid during childbirth and in the postpartum period. The comparison group consisted of 250 pregnant women who did not use the specified gel during childbirth and in the postpartum period.Results. The average age of patients in the main and the comparison group was 28.92±1.32 and 27.17±1.56 years, respectively. In both groups, primiparous women prevailed – 157 (62.80%) persons in the main group, 158 (63.20%) – in the comparison group, 93 (37.20%) and 92 (36.80%) women had the second labor respectively. There was a tendency to decrease the time of the second period of labor in women of the main group compared to the comparison group. The frequency of episiotomy was 1.63 times lower in the main group than in the comparison group (p<0.05), the rate of soft tissue injuries in childbirth – 1.32 times lower (109 (43.60%) and 144 (57.60%) women respectively; p=0.002).During the week of the postpartum period, the number of patients with discomfort in the vagina and perineum was 2.49 times less in the main group (59 (23.60%) persons) than in the comparison group (147 (58.80%) women; p<0.001), with pain – 1.85 times (88 (35.20%) and 163 (65.20%) individuals respectively; p<0.001). 132 (52.80%) women of the comparison group complained on the limitations in their daily activities due to the mentioned symptoms, which was 2.16 times more than in the main group (61 (24.40%) persons; p<0.001).Conclusions. The use of vaginal gel, which contains hyaluronic acid and decamethoxine, during childbirth and in the postpartum period for prevention of obstetric injuries and improvement the course of the postpartum period is effective, which led to a 1.32-fold decrease of women with vaginal and perineal tears (p<0.05) and 1.63 times – the frequency of episiotomy (р<0.05) and improvement of the course of the postpartum period.

Lipid Complex-Itraconazole in Thermosensitive Mucoadhesive Vaginal Gel to Enhance the Effectiveness of Therapy for Vulvovaginal Candidiasis: Formulation, Optimization, Characterization, and Ex vivo Evaluation

Lipid Complex-Itraconazole in Thermosensitive Mucoadhesive Vaginal Gel to Enhance the Effectiveness of Therapy for Vulvovaginal Candidiasis: Formulation, Optimization, Characterization, and Ex vivo Evaluation

Comparison of the efficacy of subcutaneous versus vaginal progesterone using a rescue protocol in vitrified blastocyst transfer cycles

Does administration of subcutaneous (s.c.) progesterone support ongoing pregnancy rates (OPR) similar to vaginal progesterone using a rescue protocol in hormone replacement therapy frozen embryo transfer cycles? Retrospective cohort study. Two sequential cohorts - vaginal progesterone gel (December 2019-October 2021; n=474) and s.c. progesterone (November 2021-November 2022; n=249) -were compared. Following oestrogen priming, s.c. progesterone 25 mg twice daily (b.d.) or vaginal progesterone gel 90 mg b.d. was administered. Serum progesterone was measured 1 day prior to warmed blastocyst transfer (i.e. day 5 of progesterone administration). In patients with serum progesterone concentrations <8.75 ng/ml, additional s.c. progesterone (rescue protocol; 25 mg) was provided. In the vaginal progesterone gel group, 15.8% of patients had serum progesterone <8.75 ng/ml and received the rescue protocol, whereas no patients in the s.c. progesterone group received the rescue protocol. OPR, along with positive pregnancy and clinical pregnancy rates, were comparable between the s.c. progesterone group without the rescue protocol and the vaginal progesterone gel group with the rescue protocol. After the rescue protocol, the route of progesterone administration was not a significant predictor of ongoing pregnancy. The impact of different serum progesterone concentrations on reproductive outcomes was evaluated by percentile (<10th, 10-49th, 50-90th and >90th percentiles), taking the >90th percentile as the reference subgroup. In both the vaginal progesterone gel group and the s.c. progesterone group, all serum progesterone percentile subgroups had similar OPR. Subcutaneous progesterone 25 mg b.d. secures serum progesterone >8.75 ng/ml, whereas additional exogenous progesterone (rescue protocol) was needed in 15.8% of patients who received vaginal progesterone. The s.c. and vaginal progesterone routes, with the rescue protocol if needed, yield comparable OPR.

Repurposing Disulfiram as an Antifungal Agent: Development of a New Disulfiram Vaginal Mucoadhesive Gel.

Alternative formulations need to be developed to improve the efficacy of treatments administered via the vaginal route. Mucoadhesive gels with disulfiram, a molecule that was originally approved as an antialcoholism drug, offer an attractive alternative to treat vaginal candidiasis. The aim of the current study was to develop and optimize a mucoadhesive drug delivery system for the local administration of disulfiram. Such formulations were composed of polyethylene glycol and carrageenan to improve the mucoadhesive and mechanical properties and to prolong the residence time in the vaginal cavity. Microdilution susceptibility testing showed that these gels had antifungal activity against Candida albicans, Candida parapsilosis, and Nakaseomyces glabratus. The physicochemical properties of the gels were characterized, and the in vitro release and permeation profiles were investigated with vertical diffusion Franz cells. After quantification, it was determined that the amount of the drug retained in the pig vaginal epithelium was sufficient to treat candidiasis infection. Together, our findings suggest that mucoadhesive disulfiram gels have the potential to be an effective alternative treatment for vaginal candidiasis.

Polyphenylene carboxymethylene (PPCM), the active component of the topical contraceptive Yaso-GEL, exhibits potent antimicrobial activity against Neisseria gonorrhoeae in preclinical studies

IntroductionPolyphenylene carboxymethylene (PPCM) is a condensation polymer that has both contraceptive and antimicrobial activity against several sexually transmitted viruses including HIV, herpes simplex virus, Ebola virus and SARS-CoV-2 in preclinical...

Effects of two different types of luteal support on pregnancy outcomes following antagonist fresh embryo transfer: a retrospective study

BackgroundOnly a small number of studies have reported the use of progesterone vaginal gel in combination with dydrogesterone as part of the antagonist protocol for fresh embryo transfer. Therefore, this study aimed to compare the effects of two types of luteal support on pregnancy outcomes following the antagonist protocol for fresh embryo transfer.MethodsWe performed a retrospective analysis of clinical data from infertile patients who underwent fresh embryo transfer via the antagonist protocol (2785 cycles) between February and July 2019 and between February and July 2021 at the Peking University Third Hospital Reproductive Medicine Centre. According to the luteal support received, the cycle groups were divided into the progesterone vaginal gel group (single medication or VP group; 1170 cycles) and the progesterone vaginal gel plus dydrogesterone group (combination medication or DYD + VP group; 1615 cycles). After propensity score matching, the clinical pregnancy, ongoing pregnancy, early miscarriage, and ectopic pregnancy rates were compared between the two groups.ResultsIn total, 1057 pairs of cycles were successfully matched via propensity scores. The clinical and ongoing pregnancy rates in the combination medication group were significantly higher than those in the single medication group (P < 0.05), whereas no significant differences were noted in the early miscarriage and ectopic pregnancy rates between the two groups (both P > 0.05).ConclusionsCombined luteal support after the antagonist protocol is preferred for patients undergoing fresh cycle embryo transfer.

Optimization of a Mucoadhesive Vaginal Gel Containing Clotrimazole Using a D-Optimal Experimental Design and Multivariate Analysis.

The aim of this study was to develop a suitable clotrimazole (CLT)-loaded mucoadhesive vaginal gel (CLT-MVG) for topical applications in vaginal candidiasis. Ten CLT-MVG formulations were prepared, consisting of mixtures of acid polyacrylic (Carbopol 940) and polyethene oxides, Sentry Polyox WSRN 1105 or 750, according to an experimental D-optimal design, and CLT was suspended at a ratio of 1%. The prepared CLT-MVG formulations were studied in vitro, and the formulation containing Carbopol 940 0.89% combined with PEO 1105 1.39% was identified with the optimal rheological and in vitro bioadhesion properties, ensuring the prolonged release of CLT, with a similarity factor greater than 50, indicating dissolution profile similarity for three batches of the optimized formulation. This optimized formulation showed a pH in the tolerance range, and an adequate ex vivo mucoadhesion time, while the FT-IR studies revealed no interactions between the excipients and CLT. The microscopic analysis identified a mean particle size of suspended CLT of 5.24 ± 0.57 μm. The in vitro antifungal activity of the optimized formulation was tested on twenty strains of Candida albicans and proved to be better compared to a marketed clotrimazole preparation, showing a greater inhibition effect (p < 0.05). The optimized formulation could be a good candidate for the local treatment of vaginal mycosis.

Acceptability of Single-dose Clindamycin Gel for Bacterial Vaginosis: A Randomized Controlled Trial

The goal of this study was to assess the acceptability of a single-dose bioadhesive 2% clindamycin vaginal gel for bacterial vaginosis (BV). This double-blind, placebo-controlled, randomized study compared a new clindamycin gel with placebo gel (2:1 ratio). The primary objective was efficacy; secondary objectives were safety and acceptability. Subjects were evaluated at screening, days 7 to 14 (Day 7-14), and days 21 to 30 (test-of-cure [TOC]). An acceptability questionnaire with 9 questions was administered at the Day 7-14 visit, and a subset of questions (#7-#9) was asked again at the TOC visit. At Visit 1, subjects were provided with a daily electronic diary (e-Diary) to collect information regarding study drug administration, vaginal discharge, odor, itching, and any other treatments used. Study site staff reviewed e-Diaries at the Day 7-14 and TOC visits. A total of 307 women with BV were randomized to treatment (204 to the clindamycin gel group and 103 to the placebo gel group). Most (88.3%) reported at least one previously diagnosed BV episode, and more than one half (55.4%) had experience with other vaginal treatments for BV. At the TOC visit, almost all (91.1%) of the clindamycin gel subjects described their overall experience with the study drug as "satisfied" or "very satisfied," 95.8% indicated that they would be "likely" or "very likely" to use the product again if it became available after the study and they had BV again, and 93.7% would be "likely" or "very likely" to recommend their treatment to a friend who had BV. Almost all (90.2%) clindamycin-treated subjects responded that application was "clean" or "fairly clean," as opposed to "neither clean nor messy," "fairly messy," or "messy." Although 55.4% experienced leakage in the days after application, only 26.9% of those indicated that it was bothersome. Subjects receiving clindamycin gel also reported improvement in both odor and discharge, commencing shortly after dosing and continuing through the assessment period, regardless of whether they met the critical cure criteria. A single dose of a new bioadhesive 2% clindamycin vaginal gel showed rapid resolution of symptoms and was highly acceptable as a treatment for bacterial vaginosis. gov identifier: NCT04370548.

Failed induction of labor in term nulliparous women with an unfavorable cervix: Comparison of cervical ripening by two forms of vaginal prostaglandins (slow-release pessary and vaginal gel).

To compare the rate of failed induction after cervical ripening by two forms of vaginal prostaglandins. This two-year retrospective study (January 1, 2016, through December 31, 2017) in two tertiary maternity units included nulliparous women with a singleton fetus in cephalic presentation and an unfavorable cervix requiring labor induction for prolonged pregnancy. The principal endpoint was the rate of failed induction, defined by the performance of a cesarean delivery before 6 cm of dilation. Cervical ripening was initiated by prostaglandins for 24h, using a slow-release pessary (unit A) or a vaginal gel (unit B). The care protocol of the two groups after the first 24h were similar. The women's individual characteristics were compared between the two units. The rates of failed induction were then compared between the two units, first by univariate and then by multivariable analysis adjusted for the characteristics that differed significantly between the units. Among the 17,217 women delivered in the two maternity units during the study period, 178 met our inclusion criteria (125 in unit A (slow-release pessary) and 53 in unit B (vaginal gel)). The rate of failed induction was similar: 21.6% in unit A (slow-release pessary) and 17.0% in unit B (vaginal gel) (P=0.48). The multivariate analysis did not show any difference about failed induction, time from the onset of induction to delivery, and vaginal delivery rate within 24h. The rate of failed induction of labor did not differ between slow-release pessary and vaginal gel.

Oxytocin versus prostaglandins for labour Induction of women with an unfavourable cervix after 24 hours of cervical ripening (OPIC): protocol for an open multicentre randomised non-inferiority trial

IntroductionIt remains uncertain whether the most appropriate management for women with an unfavourable cervix after 24 hours of cervical ripening is repeating the ripening procedure or proceeding directly to induction...

Cervical cerclage vs pessary in women with a sonographic short cervix.

In the present study we sought to compare the efficacy of cervical pessary to that of cerclage in terms of reducing preterm birth rates among women with a short (<25 mm) and ultra-short (<15 and <10 mm) cervix during the ultrasonographic second trimester assessment. We retrospectively searched the hospital records for singleton pregnancies diagnosed with cervical insufficiency during the second trimester of pregnancy. The McDonald cerclage was used in all women with the use of a 5mm Mersilene tape. Arabin pessary was used uniformly. In all cases 80 mg of vaginal progesterone gel was administered daily, until 37 weeks of gestation. Overall, 294 women were selected for analysis of whom 124 (42.2%) had a McDonald cerclage and 170 (57.8%) had placement of an Arabin pessary. Preterm birth rates <37 weeks were similar in both groups (C: 30/122 vs P: 35:165, p=.581) as well as PTB <34 weeks (C: 16/122 vs 15/150, p=.278). Admission to the NICU and need for CPAP were more prevalent in the cerclage group (p<.001). Analysis of cases with a cervix <15 mm and <10 mm indicated that preterm birth rates remained equal among groups whereas an increased risk of NICU admission in cases with cervical length <10 mm that were treated with cerclage. Cervical pessary may be an alternative to cervical cerclage for women with second trimester cervical shortening and its effect may persist even among cases with an ultra-short cervix. Future randomized trials are needed to ascertain these findings.

Comparing the effects of two different progesterone vaginal gels, Progeson™ and Crinone™, from pharmacokinetics study to clinical applications in patients undergone fresh embryo transfer and frozen-thawed embryo transfer via natural cycle endometrial preparation protocol.

The pharmacokinetics performance and clinical pregnancy rate of two vaginal progesterone gel, Progeson™ and Crinone™, were compared in this study. In the pharmacokinetics performance, Progeson showed similar long-term dissolution rate as Crinone. In the clinical study, 141 subjects undergone invitro fertilization (IVF) treatments were included to compare serum progesterone level and clinical pregnancy rates. Among the subjects, 78 subjects received fresh embryo transfer and 63 subjects received frozen embryo transfer via natural cycle endometrial preparation protocol. In each group, subjects were given either Crinone™ or Progeson™ for luteal phase support without combination with other progesterone products. The study showed that Crinone™ group led to higher estrogen level at mid-luteal phase in the fresh embryo transfer group, and Progeson™ group led to higher progesterone level at mid-luteal phase and pregnancy test day in the frozen-thawed embryo transfer group. Subjects received Crinone™ or Progeson™ had similar rate of pregnancy, live birth, and stillbirth in both fresh embryo transfer and frozen-thawed embryo transfer group. Thus, Progeson™ might be a suitable substitute for Crinone™ in assisted reproductive therapy.

Effect of Dhatakyadi Oil on Upapluta Yoni Vyapad with special reference to Candida albicans

Upapluta Yoni Vyapad has mentioned in many Samhita. The genital organs are afflicted by Kapha &amp; Vata, the ailment of the woman is called Upapluta which clinical features are simulated description of Monilial Vulvovaginitis specially caused by Candida albicans. Sixty (60) patients were divided into two groups i.e., Trial group and Control group with clinical features of curdy thick white vaginal discharge, vulval pruritis, vulval itching, vulval oedema. Trial group was treated with Yoni Pichu (Vaginal Tampon) by a Dhatakyadi Oil. Control group was treated with Clotrimazole vaginal gel. This study was conducted to evaluate the efficacy of Dhatakyadi Oil on Upapluta Yoni Vyapad with special reference to candida albicans. This study was a prospective, comparative and observative. This study observe significant reduction in mean scores of clinical feature and overall compliance to the treatment was excellent in the both group and p value of &lt; 0.001 was considered highly significant.

Exploring the Bioactive Mycocompounds (Fungal Compounds) of Selected Medicinal Mushrooms and Their Potentials against HPV Infection and Associated Cancer in Humans.

Medicinal mushrooms have been used as a medicinal tool for many centuries and, nowadays, are used in the prevention and therapy of various diseases, including as an adjunct to cancer treatment. It is estimated that 14-16% of global cancer cases are caused by infectious events; one well-known infectious agent that leads to cancer is the human papillomavirus (HPV). HPV is responsible for more than 99.7% of cervical cancer cases and also may play a role in vaginal, vulvar, penile, anal, rectal, and oropharyngeal carcinogenesis. Coriolus versicolor, a basidiomycetes class mushroom, consists of glycoproteins called polysaccharide-K (PSK) and polysaccharopeptide (PSP), which are mainly responsible for its effectiveness in the fight against a variety of cancers. Its beneficial effect lies in its ability to arrest different phases of the cell cycle, immunomodulation or induction of apoptosis. Coriolus versicolor extractcan reduces BCL-2 expression or increases the expression of p53 tumour suppressor genes in breast tumour cell lines. Inhibition of proliferation was also demonstrated with HeLa cells, while cervical cytology abnormalities improved in patients who locally applied Coriolus versicolor-based vaginal gel. Coriolus versicolor extract itself, and also its combination with another medicinal mushroom, Ganoderma lucidum, leads to improved HPV clearance in HPV cervical or oral-positive patients. Medicinal mushrooms can also increase the effectiveness of vaccination. This review considers the use of medicinal mushrooms as a suitable adjunct to the treatment of many cancers or precanceroses, including those caused by the HPV virus.

Formulation and In Vitro Evaluation of Mucoadhesive Sustained Release Gels of Phytoestrogen Diarylheptanoids from Curcuma comosa for Vaginal Delivery

Diarylheptanoids (DAs) characterized by a 1,7-diphenylheptane structural skeleton are considered a novel class of phytoestrogens. The DAs available in Curcuma comosa Roxb. (C. comosa) extract demonstrated significant estrogenic activities both in vitro and in vivo. This study aimed to develop and comprehensively evaluate a mucoadhesive vaginal gel for the sustained release of DAs. Different mucoadhesive polymers as gelling agents were investigated. C. comosa ethanolic crude extract was used as a source of DAs. All C. comosa gels were light brown homogeneous with pH within 4.4-4.6. Their flow behaviors were pseudoplastic with a flow behavior index of 0.18-0.38. The viscosity at a low shear rate varied from 6.2 to 335.4 Pa·s. Their mechanical and extrudability properties were associated well with rheological properties. Polycarbophil (PCP):hydroxypropyl methylcellulose (HPMC) blends had a higher mucoadhesiveness to porcine vaginal mucosa than those of PCP-based or HPMC-based gels. All C. comosa gels exhibited a sustained, zero-order DA release pattern over 72 h. Korsmeyer and Peppas equation fitting indicated a non-Fickian, case II transport release mechanism. C. comosa gels had good physical and chemical stability under low-temperature storage for up to 12 months. PCP:HPMC-based mucoadhesive gels could be a proper delivery system for vaginal administration of DAs.

The Effect of Different Luteal Phase Support Applications on Clinical Pregnancy Outcomes in Frozen-Thawed Embryo Transfer.

During the frozen-thawed embryo transfer (FET) method, controlled ovarian hyperstimulation is used. At the same time, progesterone support is given for luteal phase support. In this study, we investigated the effects of various luteal phase support agents administered orally, intramuscularly (IM), and vaginally during FET on pregnancy rates. The files of 166 patients between the ages of 21 and 44 in the Assisted Reproductive Techniques Center of Acıbadem Mehmet Ali Aydınlar University Atakent Hospital were analyzed retrospectively between 2016 and 2022. The patients' FSH, LH, E2, P4, AMH, and TSH levels were measured. The GnRH antagonist protocol was initiated on the 2nd or 3rd day of menstruation. Three types of progesterone agents were used in females with PCOS. Three different methods were applied: 50 mg/ml of IM progesterone daily, 90 mg of progesterone gel 2∗1 vaginally, and dydrogesterone acetate tb. orally 3∗1. FET was performed on women who received 21 days of treatment by thawing 5th-day embryos. B-hCG was performed on the 12th day after the transfer, and evaluations were made. The study results were evaluated as follows: for the whole study group, for those <30 years of age, for those 30-35 years of age, and for those >35 years of age. A total of 164 patients, 57 females using vaginal progesterone gel, 30 females using oral progesterone tablet, and 77 females using IM progesterone, who met the inclusion criteria, were included in the study. The pregnancy outcomes of IM progesterone application were statistically significantly higher in the entire study group and the >35 age group when compared to the vaginal progesterone gel application. It was found that the pregnancy outcomes of IM progesterone application increased statistically significantly in the <30 age group when compared to outcomes in the other groups, using vaginal progesterone gel and oral progesterone tb. We found that IM progesterone application was more effective than vaginal progesterone gel application for luteal phase support. Many randomized controlled, especially live birth rate studies, are required before results can more closely approximate those for the general population.

Prophylaxis Effect of Metronidazole Vaginal Gel in Decreasing the Risk of Surgical Site Infections after Elective Hysterectomy.

Infections are an important cause of morbidity and mortality after hysterectomy. Here, we aimed to investigate and evaluate the beneficial effects of metronidazole vaginal gel on the rate of surgical site infections in women undergoing elective abdominal hysterectomy. This is a randomized prospective, double-blind controlled clinical trial performed in 2020 in Isfahan on 108 candidates for elective hysterectomy. At the beginning of the study, we completed a checklist of the patient's characteristics (patient age, body mass index [BMI], and history of medical conditions such as diabetes, hypertension, anemia, and immune deficiency) and the cause of hysterectomy. All patients were randomized into two groups. The first group received a lubricant vaginal gel single dosage, and the second group received a 0.75% metronidazole vaginal gel single dosage the night before surgery. Patients were visited up to 6 weeks after surgery, and the frequency of infection at the surgical site was determined. The rates of infection were lower in patients who received metronidazole vaginal gel (5.8%) compared to the control group (11.6%) (P = 0.03). Patients with an estimated blood loss volume of more than 500 mL had higher rates of infection (13.46%) compared to patients with a bleeding volume of fewer than 500 mL (1.9%) (P = 0.001). We also found that patients with diabetes (13.5%) and patients with BMI more than 30 kg/m2(13.5%) had higher rates of infection compared to patients without diabetes (5.8%) and patients with BMI <30 kg/m2 (11.5%) (P = 0.001 for both). Patients with higher hospitalization duration had higher infection rates (P = 0.009). Administration of a single dosage of metronidazole vaginal gel before abdominal hysterectomy may reduce surgical site infection and have clinical values.

Vaginal progesterone gel vs. capsule for preterm birth prevention: an indirect comparison meta-analysis

Vaginal progesterone gel vs. capsule for preterm birth prevention: an indirect comparison meta-analysis

克林霉素磷酸酯阴道凝胶和甲硝唑阴道制剂治疗阳虚质细菌性阴道病的疗效观察及机制研究

克林霉素磷酸酯阴道凝胶和甲硝唑阴道制剂治疗阳虚质细菌性阴道病的疗效观察及机制研究

Diagnostics and management of vulvovaginal atrophy according to the international guidelines

Vulvovaginal atrophy is one of the genitourinary symptoms caused by estrogen deficiency which leads to the development of immature vaginal epithelium, glycogen deficiency, reduction or even elimination of lactobacilli, and secondary genitourinary tract infection. Among the main symptoms were dryness, burning, itching, and dyspareunia. Diagnosis is typically based on the patient’s complaints, signs, and symptoms. Management of vulvovaginal atrophy includes various forms of topical estrogens and non-hormonal drugs. Low-dose vaginal estrogens can be used as monotherapy or as a supplement to hormone replacement therapy (HRT). In the case of monotherapy, there is no need to add progesterone for the endometrial protection. According to the recent studies, local vaginal estrogen therapy does not increase the risk of cancer, cardiovascular disease, and venous thromboembolism. On patients with hormonophobia, an alternative method of treatment is the use of vaginal lubricants and moisturizers or who have had cancers of various localization. For instance, usage of lactic acid vaginal gels in breast cancer survivors has improved vaginal dryness and dyspareunia as compared with the placebo. Yet, vaginal estrogen therapy has better clinical effects than non-hormonal drugs.