Intravaginal Device Research Articles

Biocompatibility assessment of an integrated contraceptive and RFID-based intravaginal device in cats (Felis catus): A preliminary study

Background: An intravaginal device (IVD) made from polyethylene plastic and copper wire, integrated with a radio frequency identification (RFID) chip, was developed as a contraceptive and identity device for cats. Aim: This study evaluates the local and systemic biocompatibility of the IVD in five non-pregnant female cats. Methods: The IVD was successfully inserted into the vaginal lumen after estrogen administration. Radiographic imaging confirmed the IVD's position, which lasted up to two days post-insertion. Results: Systemic response, assessed through hematological examinations on days 0, 1, and 3 post-insertion, showed no significant changes in erythrogram and leukogram parameters. Local response, evaluated through vulvar inspection and vaginal cytology on days 0, 1, 3, and 7, revealed no neutrophil infiltration in 4 out of 5 cats, indicating compatibility with vaginal tissue. Furthermore, epithelial cell profile changes were observed, showing an increase in superficial cells, which is typical during the estrus phase. Conclusion: These findings suggest that the IVD is biocompatible and suitable for use as a contraceptive and identity device in cats. However, further long-term studies are necessary to evaluate the device's prolonged efficacy and potential for contraception failure prevention by mating trials.

Randomized trial of mechanotherapy for the treatment of stress urinary incontinence in women.

Stress urinary incontinence (SUI) presents as unintentional urine leakage associated with activities. It significantly affects quality of life (QoL) and is the most common type of incontinence in women. Current treatment options, particularly non-surgical therapies, are lacking. To assess the efficacy of mechanotherapy provided by the Flyte® intra-vaginal device during pelvic floor muscle training (PFMT). This was a randomized, controlled, double-blinded trial. Flyte is a repeat use device for conditioning and strengthening the pelvic floor muscles (PFMs). It provides two-part mechanotherapy. Part 1 is the stretching and preloading of the PFM from the internal wand. Part 2 integrates mechanical pulses which elicit muscle cellular and tissue level responses that trigger cellular regeneration, improve neuromuscular facilitation and motor learning. Subjects used the device for 5 min/day for 12 weeks. Subjects (144) were randomized and evaluated at 6 and 12 weeks. Arm A (72) received both Part 1 and Part 2 mechanotherapy for 12 weeks, whereas Arm B (72) received Part 1 therapy for 6 weeks, then crossed over to full therapy. Mean age was 50, 49, respectively, prior pelvic/abdominal surgery 26%, 46%, and previous incontinence treatments 13%, 22%. The primary endpoint was 24-h pad weight (24-HR PW) at 6 weeks. Secondary endpoints were 24-HR PW at 12 weeks and QoL [International Consultation on Incontinence Questionnaire (ICIQ), Urinary Incontinence Quality of Life (IQOL)]. Part 1 therapy had a greater than anticipated therapeutic effect. Thus, the study was underpowered to identify differences between study arms. Therefore, data were pooled to assess the effects of mechanotherapy. Twenty four-HR PW was significantly reduced at 6 weeks (p = <0.0001), with further reduction from 6 to 12 weeks (p = <0.0001). Data were stratified based on 24-HR PW severity. Significant reductions were noted in all severity groups (mild p = <0.0001, moderate p = <0.0001, severe p = <0.01). QoL was similarly improved at 6 weeks (ICIQ p = <0.0001, IQOL p = <0.0001), and 12 weeks (ICIQ p = <0.0001, IQOL p = <0.0001). Compliance was >80% at 6 weeks and 70% at 12 weeks. Two-part mechanotherapy significantly improved 24-HR PW and QoL across all severities of SUI. Improvements were noted in as little as 2 weeks and appeared to be sustained through 2-year follow up. Registered on ClinTrials.gov (NCT02954042).

Comparing CIDR with progesterone injections and eCG with human recombinant FSH for synchronizing estrous cycle in ewes.

It is desirable in estrus synchronization in sheep to avoid intravaginal devices and to shorten the program from 14 to 6 days. Moreover, replacement of eCG with safe, cheap, and efficient gonadotropin is in worldwide demand. This study investigates the possibility of replacing eCG with human recombinant FSH (hrFSH) and CIDR with progesterone injections for estrous synchronization in ewes. Assaf and Lacaune ewes (n=170) were divided into two groups and synchronized with either progesterone injections for 6 days or CIDR for 14 days. Ewes assigned in the injection group, received progesterone (37.5 mg; SC) and GnRH analogue (7.5 µg Alarelin acetate; IM) on day 0 of the experiment. On days 3 and 6, ewes received 25 and 12.5 mg progesterone (SC), respectively. On day 6, ewes in both groups received prostaglandin F2α (250 µg Cloprostenol; IM), and were divided into two subgroups to receive either hrFSH (75 IU Follitropin alfa; SC) or eCG (400 IU; IM). On day 7, fertile rams were introduced to ewes for 21 days. Data were analyzed using GLM and Glimmix. There was no difference in the respective lambing rates, prolificacy, and fecundity between CIDR (71.1, 1.63, and 1.16%) and injections (66.7, 1.55, and 1.03%); between eCG (71.4, 1.60, and 1.14%), and hrFSH (66.3, 1.58, and 1.05%, P>0.05). In conclusion, 6-day progesterone injection-based protocol produced similar results to 14-day CIDR program and hrFSH could be an effective alternative for eCG during estrus synchronization in ewes.

Customized modified therapies for ovarian cyst and persistent follicle followed with TAI in early postpartum dairy cows.

Postpartum ovarian dysfunction [ovarian cyst (OC) and persistent follicle (PF)] has been an important issue. Finding effective hormonal treatments to improve reproductive performance in dairy cows has become a necessity. Improve reproductive performance and ovarian activity in postpartum cows with specific customized treatment for OC and PFs. The study included 48 cows at 14 days P.P, which received two dosages of 500 μg IM cloprostenol, 14 days apart as presynchronization protocol. Ultrasound ovarian scans 14 days after the last injection for 4 weeks. The cows were divided into three groups according to ovarian status: OC (n = 14), PF (n = 12), and NE (n = 22). In the OC group, received 500 μg IM cloprostenol and 100 μg IM cystoriline, a second dose of cloprostenol 14 days later and a second dose of cystoriline 36 hours later, and AI after 24 hours (GnRH+ PG/PG/GnRH). In the PF group, was fitted with progesterone-releasing intravaginal device (PRID) for 9 days; the same day, they received 100 μg cystoreline then 500 μg cloprostenol 7 days later, after PRID removal AI 56 hours later (PRID + GnRH/PG). In the NE group, artificial insemination was implemented until 28 days depending on estrus detection. The ovarian activity was greatly affected by the customized treatments, leading to enhanced follicular and luteal activity, particularly after the PGF2α injection. The OC and PF groups showed substantial estrus responses of 71.43% and 75.02%, respectively, during AI time. While the NE group had an ovulation rate of 54.5% and a pregnancy rate of 31.8%, the treatment groups showed marked improvements in reproductive performance. The ovulation rates in the OC and PF groups were 71.43% and 75% and the pregnancy rates at the 1st artificial insemination were 64.28% and 66.7%. Improving reproductive performance and minimizing the time to first service are possible advantages of early case-specific treatment for postpartum cows with OC and PFs.

GnRH analogs induce a LH peak and increase pregnancy per timed-AI in ewes

To date, there have been no studies testing the capacity of GnRH analogs and respective doses to induce a LH peak in sheep. In this sense, the present study aimed to evaluate the capacity of different synthetic forms and doses of GnRH in inducing LH release in sheep, and the effect of GnRH administration at timed artificial insemination (TAI) on pregnancy per timed-AI. In experiment 1, ewes (n = 40) received an intravaginal device (IVD) of medroxyprogesterone acetate (MPA; 60 mg) for 7 d and prostaglandin F2α analog on Day 5. On Day 7, the ewes were allocated randomly into one of eight groups (n = 5/group), which received a GnRH analog at a specific dose, as follows: lecirelin (12.5 or 25 μg), gonadorelin (50 or 100 μg), buserelin acetate (4.2 or 8.4 μg), or deslorelin (375 or 750 μg). Blood samples for LH determination were obtained at 0, 2, 4, and 6 h after GnRH and the IVDs were removed after the last blood collection. The maximal LH concentration induced by gonadorelin at doses of 50 μg and 100 μg (12.0 ± 2.4 ng/mL and 28.6 ± 7.1 ng/mL, respectively) was lower (P < 0.05) than serum LH induced by 8.4 μg of buserelin (78.9 ± 12.9 ng/mL), 375 μg and 750 μg of deslorelin (75.6 ± 7.4 ng/mL and 72.1 ± 10.6 ng/mL, respectively) and 12.5 μg and 25 μg of lecirelin (73.3 ± 17.8 ng/mL and 61.6 ± 5.9 ng/mL, respectively). However, the maximal LH concentration induced by 4.2 μg of buserelin (49.4 ± 5.9 ng/mL) was similar (P > 0.05) to the 100 μg of gonadorelin. The total release of LH (area under the curve – AUC) after treatment with 50 μg of gonadorelin (31.7 ± 5.9 ng h/mL) was lower (P < 0.05) than after other agonists. In a second experiment, 330 ewes were treated with IVD containing MPA for 7 d. Simultaneously with IVD removal, 250 μg of cloprostenol and 200 IU of eCG were administered. Then, ewes were assigned randomly to either no further treatment (control); or to receive 4.2 μg of buserelin acetate (GnRH group) at cervical TAI, which was performed with fresh semen 54 h after IVD withdrawal in all the animals. Higher pregnancy per timed-AI was observed for GnRH (50.3 %) compared to control (40.7 %). We conclude that buserelin acetate (8.4 μg), lecirelin (12.5 and 25 μg) and deslorelin (375 and 750 μg) induced a greater stimulatory effect on LH secretion than gonadorelin treatment. Furthermore, buserelin acetate treatment at TAI increased pregnancy per timed-AI in ewes previously treated with MPA and eCG.

PSII-10 Effect of Equine Chorionic Gonadotrophin-Like Glycoprotein Treatment on Fertility in Angus Cows Subjected to a 7-Day Co-Synch Protocol

Abstract This study evaluated the effect of administering a glycoprotein with equine chorionic gonadotropin like activity produced by recombinant DNA technology (eCG-like) associated with a 7-d Co-Synch protocol on estrus rate (ER) and pregnancy per timed AI (P/TAI). A total of 1,344 suckled Angus cows (primiparous, n = 381; multiparous, n = 963) from 11 herds were scanned at initiation of synchronization protocol by transrectal ultrasonography and the presence of corpus luteum (CL) and uterine tone was used to classify them by cycling. On day -10, cows received 100 μg GnRH analogue and a progesterone intravaginal device (IVD; 1.0g progesterone) for 7 days. At IVD removal, cows were administered 500 μg of cloprostenol and randomly assigned to receive 400 IU of eCG-like glycoprotein (Syntex S.A., Argentina, PCT/EP2019/073277; eCG-like, n = 665) or to remain as untreated (Control, n = 679). Also on day -3, paint was applied on the sacrum to the tail head of each cow. Finally, 100 μg GnRH analog were injected concurrently with TAI on Day 0 (66h after IVD removal) and the ER was evaluated by the degree of paint loss. Pregnancy to TAI was determined on day 30 by transrectal ultrasonography when an embryo and fluid were detected in the uterus. Body condition score (BCS; scale = 1-9) was evaluated on days -10 and 30. Optimal BCS was considered ≥ 5 and BCS balance between days -10 and 30 was classified as negative (lost BCS) or positive (maintained or gained BCS). The associations among treatment, parity, cyclicity at initiation of protocol, optimal BCS on day -10, and their interactions and ER and P/TAI were analyzed by GLIMMIX (SAS 9.3). Estrus expression and BCS balance were also included as effects in the model of pregnancy per TAI. The effect of herd was included as a random effect. The model specifications included an option to retrieve the mean, SEM, and an adjustment for multiple comparisons (Tukey-Kramer). The percentage of acyclic cows was 31.3%. The ER in cyclic cows was 64.9% and the eCG-like treatment increased ER only in anestrus cows (55.8 vs. 44.3%; Treatment x cyclicity interaction; P = 0.03). The percentage of cows with negative BCS balance was 27.2%. The P/TAI in cows with positive BCS balance was 48.4% and the eCG-like treatment increased P/TAI only in cows with negative BCS balance (44.7% vs. 30.5%; Treatment x BCS balance interaction; P = 0.01). In conclusion, the addition of a recombinant eCG-like glycoprotein to a 7-day Co-Synch protocol increased estrus expression in anestrus Angus cows and P/TAI in those with negative body condition score balance. However, this addition did not influence the estrus expression in cycling cows or on P/TAI in those with positive BCS balance.

Plasma Progesterone Hormone Levels After Utilizing a Newly Developed Estrus Inducing Device [P-SyncTM], as Well as Field Studies Comparing a Commercial Intravaginal Device for Timing of Insemination in Dairy Cattle

Plasma Progesterone Hormone Levels After Utilizing a Newly Developed Estrus Inducing Device [P-SyncTM], as Well as Field Studies Comparing a Commercial Intravaginal Device for Timing of Insemination in Dairy Cattle

CASE REPORT: A SUCCESSFUL TREATMENT STRATEGY FOR CYSTIC OVARIAN DISEASE IN A DAIRY COW

A 5-year-old multiparous lactating Holstein cow was reported to have cystic ovarian disease with a history of whitish vaginal discharge on the 80th day postpartum. On the 83rd day postpartum, transrectal ultrasonography revealed a thick-walled cystic structure with visible cobwebs in the cavity, measuring 4.2[Formula: see text]cm × 3.4[Formula: see text]cm in diameter on the right ovary. The serum progesterone (P4) concentration was 6.82[Formula: see text]ng/mL, leading to a diagnosis of luteinized follicular cyst. Transvaginal aspiration of the cyst was performed to decrease the compression of ovarian stroma by the cyst, followed by intramuscular administrations of cloprostenol and buserelin. A 1.9[Formula: see text]cm diameter corpus luteum was detected on the right ovary nine days after aspiration, with a serum P4 concentration of 1.29[Formula: see text]ng/mL. Continual hormone treatment was followed, consisting of an injection of buserelin and an intravaginal progesterone-releasing device inserted for seven days. After seven days, two corpora lutea were noted on the right ovary with an average diameter of 2.8[Formula: see text]cm and 1.8[Formula: see text]cm, respectively. The device was removed and the cow showed a P4 concentration of 11.22[Formula: see text]ng/mL on that day. Estrus induction was conducted with two low doses of cloprostenol followed by an injection of gonadorelin, to induce a complete luteolysis and the following ovulation to fit a fixed-timed artificial insemination (AI). Pregnancy was confirmed 33 days after AI. Although the number of days open was 102 in this case, it took a total of 19 days from treatment to pregnancy.

Pelvic floor muscle training delivered via telehealth to treat urinary and/or faecal incontinence after gynaecological cancer surgery: a single cohort feasibility study

PurposeTo assess the feasibility and clinical outcomes of telehealth-delivered pelvic floor muscle training (PFMT) for urinary incontinence (UI) and/or faecal incontinence (FI) after gynaecological cancer surgery.MethodsIn this pre-post cohort clinical trial, patients with incontinence after gynaecological cancer surgery underwent a 12-week physiotherapist-supervised telehealth-delivered PFMT program. The intervention involved seven videoconference sessions with real-time feedback from an intra-vaginal biofeedback device and a daily home PFMT program. Feasibility outcomes included recruitment, retention, engagement and adherence rates. Clinical outcomes were assessed at baseline, immediately post-intervention and a 3-month post-intervention using International Consultation on Incontinence questionnaires for UI (ICIQ-UI-SF) and Bowel function (ICIQ-B) and the intra-vaginal biofeedback device. Means and 95%CIs for all time points were analysed using bootstrapping methods.ResultsOf the 63 eligible patients, 39 (62%) consented to the study. Three participants did not complete baseline assessment and were not enrolled in the trial. Of the 36 participants who were enrolled, 32 (89%) received the intervention. Retention was 89% (n=32/36). The majority of participants (n=30, 94%) demonstrated high engagement, attending at least six videoconference sessions. Adherence to the daily PFMT program was moderate, with 24 participants (75%) completing five-to-seven PFMT sessions per week during the intervention. All clinical outcomes improved immediately post-intervention; however, the magnitude of these improvements was small.ConclusionTelehealth-delivered PFMT may be feasible to treat incontinence after gynaecological cancer surgery.Trial registrationClinicalTrials.gov Identifier: ACTRN12621000880842)

Comparison of Gonadotropin-Releasing Hormone versus Estrogen-Based Fixed-Time Artificial Insemination Protocols in Grazing Bos taurus Suckled Beef Cows.

Fixed-timed artificial insemination (FTAI) protocols for beef cattle in South America are primarily based on estradiol esters and intravaginal progesterone-releasing devices (IVPD). The objective of this study was to determine the optimal gonadotropin-releasing hormone (GnRH)-based protocol as an alternative to the use of estrogen-based protocols in grazing Bos taurus suckling beef cows. All cows received an IVPD on the day of protocol initiation and prostaglandin F2α (PG) plus equine chorionic gonadotropin (eCG) treatments at the time of IVPD removal. In Experiment 1, cows (n = 235) were randomly assigned to one of four treatments: (i) 7-day estradiol = 2 mg of estradiol benzoate (EB) at IVPD insertion on Day 9 and 1 mg of estradiol cypionate (ECP) at IVPD removal on Day 2; (ii) 7-day GnRH = 10 µg of GnRH at IVPD insertion on Day 10, IVPD removal on Day 3 and GnRH at FTAI; (iii) 7 & 7 estradiol = PG at IVPD insertion on Day 16, EB on Day 9 and ECP at IVPD removal on Day 2; (iv) 7 & 7 GnRH = PG at IVPD insertion on Day 17, GnRH on Day 10, IVPD removal on Day 3 and GnRH at FTAI. In Experiment 2, cows (n = 462) were randomly assigned to one of four treatments: (i) 6-day estradiol = EB at IVPD insertion on Day 9, IVPD removal on Day 3 and GnRH at FTAI; (ii) 7-day estradiol; (iii) 7-day GnRH; (iv) 7 & 7 GnRH. In Experiment 1, plasma progesterone concentrations and percentage of cows with a corpus luteum (CL) at IVPD removal, and pregnancy per AI (P/AI) were greater for cows subjected to GnRH-based protocols compared with cows subjected to estrogen-based protocols (p < 0.01). In Experiment 2, cows subjected to the 7 & 7 GnRH protocol had the greatest P/AI (p < 0.01). In summary, GnRH-based FTAI protocols resulted in similar or greater P/AI compared to estrogen-based FTAI protocols in grazing postpartum Bos taurus suckled beef cows. The greatest P/AI was attained with the 7 & 7 GnRH protocol.

Evaluation of minimally invasive estrus synchronization protocols in brown brocket deer (Subulo gouazoubira)

This study aimed to evaluate minimally invasive protocols for estrus synchronization in the brown brocket deer (Subulo gouazoubira). Females were submitted to Latin square design, in different treatments. All females received 0.25 mg of estradiol benzoate on the first day of treatment, concomitant with one of the following sources of progesterone: (1) DIP: an intravaginal progesterone releasing device for eight days, (2) MGA1x: once a day (in the morning) oral dose of 1 mg melengestrol acetate for eight days, (3) MGA2x: twice a day (morning and afternoon) oral doses of 0.5 mg of MGA for eight days, (4) P4LA: a single i.m. administration of 75 mg of long-acting progesterone (P4LA). Eight days after the beginning of each treatment, females received an i.m. administration of 265 µg of prostaglandin (PGF2α; cloprostenol). Treatment efficacy was evaluated by manifestation of behavioral estrus after treatment and concentration of fecal progesterone metabolites (FPM). The time to onset of estrus in treatment P4LA was significantly longer (180 ± 38.9 h) compared to DIP (63 ± 6.6 h), MGA1x (53 ± 14.4 h) and MGA2x (41 ± 10.1 h) (P = 0.008). According to individual baseline FPM and FPM concentration during the days after estrus, the corpus luteum formation was suggested in all females which responded to the treatments (93.75 %). Low synchrony, longer interval between PGF2α administration and onset of estrus suggest that the P4LA dose (75 mg) is too high and not effective for S. gouazoubira. DIP, MGA 1x and MGA 2x, were effective in estrus synchronization.

Effects of estradiol cypionate dosage and body condition on reproductive performance of Nellore cattle synchronized for timed-artificial insemination

This experiment was designed to evaluate the effects of increasing doses of estradiol cypionate (ECP) and different body condition score (BCS) on reproductive performance of Bos indicus beef females assigned to a timed-artificial insemination (TAI) management. In this experiment, 1683 Bos indicus Nellore cows were blocked by parity and assigned to receive 1) an intravaginal P4 device (1.9 g of P4) and 2.0 mg of estradiol benzoate on day −11, 12.5 mg (i.m.) of dinoprost tromethamine, 300 IU (i.m.) of equine chorionic gonadotrophin, 0.6 mg (i.m.) of estradiol cypionate and CIDR withdrawal on day −2, followed by TAI on day 0 (n = 849; 0.6ECP) or 2) the same synchronization protocol with 1.0 mg of ECP on day −2 (n = 834; 1.0ECP). In both treatments, estrus expression was measured between days −2 and 0. Body condition score (BCS) was evaluated on days −11, 31, and 71 of the experiment and the BCS variation (Δ) was also determined between these timepoints. Transrectal ultrasonography was performed on days 31, 71, and 111 for pregnancy rate determination. All binary data were analyzed using cow as the experimental unit with GLIMMIX, whereas continuous variables were analyzed with the MIXED procedure of SAS. No treatment effects were observed on estrus expression rate. Treatment × BCS interactions were observed for pregnancy rates in all time points (days 31, 71, and 111), as 1.0ECP cows with a LOW BCS also had a greater P/AI than cows assigned to 0.6ECP. In summary, increasing the dose of ECP benefited the reproductive performance of Nellore beef cows with a reduced BCS (≤2.75), whereas no benefits were seen when the BCS was considered adequate (>2.75).

Toward Patient-specific Pessary to Manage Pelvic Organ Prolapse: Design and Simulation.

This study proposed a novel design and personalized approach to developing an intra-vaginal device, also known as a pessary, for the treatment of Pelvic Organ Prolapse (POP). Although POP is likely to have a more diverse dynamic than other health conditions in women, it is currently treated as a "one-shape-fits-all" problem in all cases. Pessaries are conservative devices inserted into the vagina to support its internal structure and predominantly come in a ring shape design. Failure rates as high as 50% within the first year of use have been attributed to the poor design of these pessaries; with symptoms such as irritation, bleeding, and lacerations felt by most users. To address this problem, a new base shape design was proposed and its deformation was examined using Finite Element Analysis (FEA). Based on the anatomical measurements of each patient, the base design can be adjusted accordingly. To demonstrate the effectiveness of the proposed design, a comparative study was conducted with the most commonly used support pessary, also known as the ring pessary. In order to model the large deformation of the pessaries, the hyperelastic constitutive law (Yeoh model) was fitted to the available stress-strain data of SIL 30 (a silicone urethane resin supplied by Carbon Inc.). The results showed that re-directing the reaction forces of the pessary towards the lateral walls, supported by the pelvic bones, could decrease the overall displacement of the pessaries, and provide effective symptomatic relief thereby, delaying or preventing surgical procedures.Clinical relevance- There is a clear clinical need to develop a more effective conservative therapy for managing POP. The personalized pessaries proposed in this paper can be an effective method for providing symptomatic relief and avoiding displacement, compared to the currently available devices on the market. Made-to-measure for each patient, the devices are anatomically suited and can be adjusted throughout a patient's treatment plan to allow for higher compliance and overall success rate.

Effect of delayed timing of artificial insemination with sex-sorted semen on pregnancy per artificial insemination in synchronized dairy heifers managed in a seasonal-calving pasture-based system

The objective of this study was to evaluate the timing of artificial insemination (AI) with frozen-thawed sex-sorted semen on pregnancy per AI (P/AI) in dairy heifers. A 6-d progesterone Co-Synch protocol was used for ovulation synchronization of dairy heifers, with timed AI (TAI) coincident with (TAI-0) or 8 h (TAI-8) after the second injection of GnRH, corresponding to either 48 h or 56 h after removal of the progesterone-releasing intravaginal device. Pregnancy diagnosis was conducted by transrectal ultrasound scanning of the uterus 34 d after TAI (n = 816 records available for analysis). Generalized linear mixed models were used to examine the effects of treatment on P/AI. Treatment (n = 2), herd (n = 11), and treatment × herd were included as categorical fixed effects. Heifer body weight and Economic Breeding Index values for milk production, fertility, calving performance, beef carcass, cow maintenance, cow management, and health were included as continuous fixed effects. Heifer ID was included as a random effect. Pregnancy per AI was greater for TAI-8 heifers (59%) compared with TAI-0 heifers (50%). Pregnancy per AI ranged from 38% to 75% between herds but there was no treatment × herd interaction. The fertility subindex (positive) and the cow management subindex (negative) were the only continuous animal variables associated with P/AI. Delaying the timing of AI with frozen-thawed sex-sorted semen by 8 h in dairy heifers enrolled on a 6-d progesterone Co-Synch protocol improved P/AI.

Clinical Performance and Safety of Vaginal Ovules in the Local Treatment of Nonspecific Vaginitis: A National, Multicentric Clinical Investigation

PurposeNonspecific vaginitis is a distinct clinical entity with particular microscopic and immunologic features. There is currently no standard of care for women with nonspecific vaginitis. The aim of our study was to assess the change in vaginal symptoms score after 3 months of treatment with an intravaginal medical device in participants with abnormal vaginal discharge and specific signs and symptoms. As secondary objectives, the study analyzed other clinical and microscopic features, such as vaginal discharge aspect, change in vaginal pH, change in vaginal microbiome, and vaginal inflammation. MethodsThe study population included 47 participants with symptomatic vulvovaginitis, distinct from candidiasis, trichomoniasis, or bacterial vaginosis. The study design included 2 research sites from Romania. The treatment protocol consisted of 1 ovule per day inserted intravaginally during 15 consecutive days. The total study duration was 3 months. FindingsThe intravaginal medical device had a positive impact on the vaginal symptoms score for 72.34% of the study participants. Topical administration of the ovules balanced vaginal pH values and significantly reduced signs of inflammation between study visits. ImplicationsThis intravaginal medical device had curative effects that support its use as a stand-alone treatment in women with nonspecific vaginitis. A second clinical investigation is ongoing to evaluate the clinical efficacy of the device in postoperative care of cervical and vaginal wounds traumatic or secondary to surgical interventions. ClinicalTrials.gov identifier: NCT04735705.

GnRH34 with or without estradiol cypionate in timed AI in Bos indicus beef cows

Two experiments were performed to evaluate the effects of GnRH treatment on the fertility of suckled Nelore beef cows treated with an estradiol/progesterone (E2/P4)-based protocol for timed artificial insemination (TAI). Experiment 1 focused on determining the effects of estradiol cypionate (EC) on ovulation in TAI cows treated with GnRH 34 h after removal of the intravaginal P4 device (IPD). Suckled cows (n = 26) were treated with 2 mg estradiol benzoate (EB) and IPD containing 1 g P4. After 8 days, IPDs were removed, and all cows were treated with 150 μg of d-cloprostenol (prostaglandin F2 alpha analog) and 300 IU of equine chorionic gonadotropin (eCG), then separated into two treatment groups consisting of cows who received 1) saline 0.9% i.m. (GnRH34 group) or 2) 0.6 mg i.m. of EC (EC-GnRH34 group). On day 9 (05:00 p.m.), all cows were given GnRH (10.5 μg of buserelin acetate) i.m. No differences were observed between the groups (P > 0.05) in the time of ovulation after IPD removal or in the proportion of cows ovulating. Experiment 2 focused on determining the effects of GnRH34 along with or in the absence of EC on day 8 on pregnancy per AI (P/AI) in postpartum beef cows. Cows (n = 981) were treated similarly to those in Experiment 1, but an additional group, the EC-GnRH48 group, was included, in which cows received EC on day 8 whereas those that did not show estrus received GnRH at TAI. Thus, in this experiment, groups consisted of GnRH34 (n = 322), EC-GnRH34 (n = 335), and EC-GnRH48 (n = 324). A higher rate of estrus expression was observed in cows treated with EC following IPD removal (EC-GnRH34: 69%, EC-GnRH48: 64.8%) than in cows in the GnRH34 group (45.6%). No difference in P/AI was observed between the treatment groups (P = 0.45), but P/AI in cows in the EC-GnRH34 group (64.2%) tended to be greater (P = 0.1) than in cows in the GnRH34 group (58%). In summary, although ovulation synchrony did not differ among the groups, P/AI in cows treated with EC and GnRH 34 h after IPD removal tended to be greater than in cows treated solely with GnRH; this was most likely due to a shorter proestrus/estrus period, considering the lower proportion of cows that displayed estrus in the GnRH34 group. Finally, given that P/AI did not differ between the EC-GnRH34 and EC-GnRH48 groups, our results suggest that, for cows not displaying estrus, administration of EC at the time of IPD removal followed by treatment with GnRH 48 h afterward represents the most cost-efficient TAI strategy for South American Zebu-based beef operations.

Vaginal temperature modeling in Holstein cows and cluster analysis by the cophenetic correlation coefficient

The objective was to establish a model for the prediction and characterization of vaginal temperature in Holstein cows, based on environmental predictors and thermal comfort indices, through cluster analysis, validation by the cophenetic correlation coefficient, and multiple regression analysis. The micrometeorological characterization of the site was carried out by recording the air temperature (Tair), the relative humidity (RH), the black globe temperature (BGT), the black globe temperature and humidity (BGHI), and dew point temperature (TDP). The recording of vaginal temperature (Tv) was performed in eight dairy cows using temperature sensors, equipped with data loggers, coupled with intravaginal devices. The data were analyzed using descriptive statistics and cluster analysis (CA) by using the hierarchical agglomerative method based on the value of the cophenetic correlation coefficient (CCC >0.70), in which representative physiological models were established, characterizing the Tv through multiple regression. In the afternoon the coefficient of variation (CV) was low for all variables, indicating homogeneity of the meteorological variables and efficiency of the ventilation system. The temperature and humidity index (THI) was mild only on the morning. There was a variation of 0.28 °C of Tv between shifts, sufficient to characterize the condition of comfort and stress of the animal, with values above 39 °C indicating animal stress. Tv showed strong correlation with BGT, Tair, TDP and RH, assuming that physiological variables, such as Tv, tend to have greater relationship with abiotic variables. Empirical models were established for estimating Tv based on the analyses performed in this study. Model 1 is recommended for TDP ranges of 14.00–21.00 °C and RH of 30–100%, while model 2 can be used for Tair situations up to 35 °C. The regression models for estimating Tv are promising for characterizing the thermal comfort of dairy cows housed in compost barn systems.

Cultural considerations and beliefs surrounding preterm birth in Kenya and South Africa

BackgroundPreterm birth (PTB) is a global health epidemic, sub-Saharan Africa is severely impacted due to its limited healthcare resources. Pregnancy knowledge, cultural beliefs and practices play a role in the identification of risk and management of PTB. This study explored knowledge, understandings, cultural beliefs and attitudes to pregnancy and PTB, as well as cultural considerations for the introduction of an intravaginal device which could be used to identify PTB risk.MethodsQualitative research was conducted in South Africa and Kenya. In-depth interviews were conducted using semi-structured guides with women with a history of PTB (n = 10), healthcare providers (n = 16) and health systems experts (n = 10); and 26 focus group discussions with pregnant women seeking antenatal care (n = 132) and community male partners/fathers (n = 54). Interviews/discussions were transcribed, translated, and analysed thematically.ResultsPregnancy knowledge, especially for first time pregnancies was poor, with many reporting late entry to antenatal care. Knowledge about PTB was understood in terms of gestational age, weight or small size of baby, with concerns about long term health and stigma. Various risk factors for PTB were described, including those related to traditions and beliefs of witchcraft/curses. Cultural practices, such as the use of traditional medicines and pica, and religion and its impact on health seeking behaviour were also viewed as risk factors. Although insertion of intravaginal devices was not widely acceptable in traditional communities, especially during pregnancy, it was felt that the use of one to detect risk of PTB would be accepted if proven effective in reducing PTB risk.ConclusionsVarious culturally-informed beliefs exist which explain understandings of and attitudes toward pregnancy, pregnancy risk, and PTB. An inclusive exploratory process is critical to facilitate an understanding of the beliefs and traditions which could impact the introduction and design of a product to detect the risk of PTB.

Intravaginal progesterone device reinsertion during the early luteal phase affects luteal function and embryo yield in superovulated ewes

This study checked the efficacy of progesterone (P4) device reinsertion during the early luteal phase on luteal function and embryo yield in superovulated crossbred ewes. Twenty multiparous ewes received an intravaginal P4 device for nine days (D0 to D9) followed by six decreasing doses (25, 25, 15, 15, 10, 10%) of 133 mg pFSH i.m. at 12 h intervals, starting 60 h before P4 device removal. Ewes were naturally mated at 12 h intervals while in estrus. On D13, ewes with viable corpora lutea (CL; n = 19) were equally allocated for receiving their P4 device reinsertion (G-P4; n = 10) or not (G-Control; n = 9). On D17, the P4 device was removed, and all females received the cervical relaxation protocol 16 h to 20 min before non-surgical embryo recovery. CL count and their functionality classification were performed on D13 and D17 by transrectal B-mode and color Doppler ultrasonography (US). Plasma P4 concentrations (ng/mL) of G-P4 ewes increased (P < 0.05) over the days, being greater on D17 (9.2 ± 2.8) than on D9 (1.9 ± 0.7) and D13 (1.6 ± 0.4). The overall CL count per ewe tended to be greater (P = 0.09) in G-P4 compared with G-Control. The occurrence of premature regression of corpora lutea did not differ (P > 0.05) between G-P4 (30.0%) and G-Control (44.4%). The number of ova/embryos recovered was greater (P < 0.05) in G-P4 (11.6 ± 2.9) compared with G-Control (3.7 ± 2.0), respectively. Altogether, the reinsertion of the P4 device for four days after superovulation in ewes promotes greater P4 concentrations, resulting in greater ova/embryos recovered.

Factors affecting pregnancy rates in acyclic recipient mares prepared with an intravaginal progesterone device

In acyclic embryo recipient mares, artificial cycle protocols are conventionally based on estradiol followed by long acting (LA) progesterone injections. The use of intravaginal devices has been encouraged because it allows a rapid resynchronization of recipients (Rigoleto-Júnior et al., Journal of Equine Veterinary Science 2021; 97:103325) and days of estradiol injections have also been discussed (Silva et al., Journal of Equine Veterinary Science 2021; 103:103669), but further studies are needed to develop more appropriate protocols. The present work aimed to evaluate factors that affect fertility in a commercial ET program. A total of 114 healthy mares (5-15yr-old) were used as embryo recipients and divided into two groups according to ovarian activity: cyclic (n=57) and acyclic (n=57, anestrus or transitional). Day-0 was defined as the day of ovulation in the cyclic group and the day of a 1g intravaginal P4 device (iP4) insertion in the acyclic group. Before iP4 insertion, 17β-estradiol doses varied from 0 to 10mg daily depending on the presence of natural or induced uterine edema that ranged from 3 to 7 days in duration. A one-by-one Pearson's Chi-square test was used to compare pregnancy rates between groups and the effects on pregnancy rate of 1) number of days of 17β-estradiol injections, 2) uterine edema (0-4 score)on D0 in the acyclic group, and 3) day of ET in both groups. Plasma P4 concentrations were evaluated daily by RIA in acyclic (n=10) and cyclic (n=13) mares from D0 to D7. Repeated measure models followed by Tukey's test were used to compare mean plasma P4 within groups. Pregnancy rates did not differ between acyclic (82%, 47/57) and cyclic (75%, 43/57) mares (P=0.5). Uterine edema on Day 0 (P=0.7) and day of ET (P=0.05) did not affect pregnancy rates of acyclic mares. Three days of estradiol treatment in acyclic mares resulted in a lower pregnancy rate (P=0.0425) than four days of injections. For cyclic recipient mares, day of ET affected pregnancy rates (P=0.0001) where D4 (96%, 26/27) showed higher pregnancy rates than D5 (66.7%, 12/18) and D6-7 (41.7%, 5/12), but D5 and D6-7 did not differ. Mean plasma P4 concentrations varied over days for both groups (P>0.05). In cyclic mares, mean plasma P4 increased daily to D5 (plasma P4 = 10ng/mL) followed by a plateau, whereas in the acyclic group, iP4 insertion caused an abrupt rise in plasma P4 concentration within 24h (plasma P4=5.67mg/mL) followed by a gradual daily fall to D7 (plasma P4=2.78mg/dL). In conclusion, the use of acyclic recipient mares prepared with iP4 results in similar pregnancy rates as in cyclic mares despite differences in the plasma P4 profile.