Intravaginal Culture Research Articles

Alternatives to in vitro fertilization

There have been concerns on the potential overuse of invitro fertilization (IVF) in view of the lack of evidence on effectiveness in certain populations, potential short and long-term safety risks, and economic considerations. On the other hand, the use of alternatives to IVF seems to be underappreciated in clinical practice as well as research. In this review, we summarized the up-to-date evidence on the effectiveness, safety as well as cost-effectiveness of different alternatives to IVF, including expectant management, intrauterine insemination, tubal flushing, invitro maturation as well as intravaginal culture. We also discussed the trend of IVF use over the last decade and the available tiers of service because of intravaginal culture, and revisited the roles of different alternatives to IVF in modern reproductive medicine from both clinical and research perspectives.

Intravaginal embryo culture: a successful alternative to standard IVF that may improve access to care.

To discuss existing literature and current use of intravaginal culture (IVC) as an option for patients seeking fertility therapies. IVC is the combination of oocytes and sperm with culture media in a sealed device that is placed vaginally and left in place while fertilization and early embryo development occurs. Studies show that IVC is safe, well-tolerated, and has similar outcomes in patients as compared to standard in vitro fertilization techniques (conventional insemination and/or intracytoplasmic sperm injection). The new device, INVOcell, while recommended by the FDA for minimal stimulation and up to 72 h of culture and seven oocytes, has been used successfully with more oocytes and for 5 days (until blastocyst stage for transfer) in many centers. Live birth rates and neonatal outcomes are reassuring. Infertility is a common disease and the vast majority of patients globally will not seek care. IVC may improve access to care, lower costs, provide an alternative for patients who have ethical or religious concerns, and be an increasingly utilized option for those seeking ART therapies. It may also ease workflow burdens in labs where space, equipment, or highly trained lab staff are scarce. More data is warranted to track cumulative outcomes and optimize the ideal patient candidate, but it is a viable alternative in the armamentarium of fertility therapies.

A case series to examine the perinatal outcomes of infants conceived by intravaginal culture (IVC).

In vitro fertilization (IVF) has been a well-established method for treating infertility for over four decades. The mainstay method of culture of oocytes and embryos has been in gas incubators. More recently, the novel use of a gas-permeable closed vessel to culture oocytes and embryos in the vagina, intravaginal culture (IVC), has been introduced as a viable lower-cost option for infertility patients. Several studies have studied the efficacy of IVC; however, there is no data on the perinatal outcomes of the babies born using this newer technology. Our study is a retrospective case series (n = 66) from a single center, uniquely examining the perinatal outcomes of infants born after IVC. There were 50 singleton and 16 twin gestations in this case series. For singleton infants conceived via IVC (n = 50), the mean gestational age at delivery was 38weeks and 4days, and the mean birth weight was 3159.1 + / - 501.5g. Four infants were born with low birth weight, three were born preterm, and one was born macrosomic. The twin pregnancies had a mean gestational age at delivery of 33weeks 4days and a mean birth weight of 1992.9 + / - 620.7g. Twenty-seven infants met the criteria for low birthweight, and twenty-four infants delivered preterm. No twin infants met the criteria for macrosomia. This case series provides an initial description of the perinatal outcomes of IVC conceived infants, which shows no concerning trends in adverse birth outcomes for singleton infants. As expected, IVC twin gestations had a high rate of low birth weight and preterm delivery. Continued larger studies are essential to provide more comprehensive data on perinatal outcomes of infants conceived by this new technology.

Randomized prospective study comparing conventional In Vitro Fertilization technique to Intravaginal Culture with the INVOCELL™ device for 3 and 5 days.

The objective was to analyse and compare the formation and quality of the embryos developed using conventional in vitro fertilization (IVF) and IVC techniques with an INVOCell™ device. Two groups were formed, with eight couples in each, one in culture for three days (D3) and another in culture for five days (D5), using intravaginal culture technique with an INVOcell device and a conventional in vitro fertilization technique. Embryo formation in Group D5 showed 46.7% (IVC) and 40% (IVF) of recovered blastocysts. In the group D5, the conventional IVF, better embryo development dynamics was observed, with 66% of expanded blastocysts, against 28% in the IVC. Group D3 showed 75% (IVC) and 53% (IVF) of embryo formation. Embryonic quality in Group D3 demonstrated that IVF embryos had a better synchrony in the number and quality of blastomeres. All embryos recovered in Group D3, in both techniques, did not show fragmentation. The pH of the medium contained in the INVOCell™ device in both Groups D5 and D3 showed no differences. The means were 7.26 and 7.25, respectively. The pH of the medium used in IVF was 7.29 in both groups. Microbiological analyzes of the culture media contained in the INVOCell™ devices used in Group D5 were negative. The results showed that the IVC technique, using the INVOCell™ device, provided a healthy and balanced environment for the development and obtaining of quality embryos with three and five days of culture.

DUO INTRAVAGINAL CULTURE (IVC) PROVIDES A POTENTIALLY ADVANTAGEOUS SECOND SOURCE OF EMBRYOS FOR SAME-SEX FEMALE COUPLES

Intravaginal culture (IVC) with the INVOcell™ device (INVO Bioscience, FL, USA) is a recent addition to assisted reproductive technology (ART). While originally positioned to increase access to in vitro fertilization (IVF) by decreasing costs, IVC’s role in ART continues to evolve. One expanded use of IVC is to provide an opportunity for same-sex female couples to physically share in the culture and gestating process by allowing one partner to incubate embryos and the other to carry the pregnancy. Another possible advantage of IVC in this population is the opportunity to have each partner concomitantly carry an INVOcell device with sibling oocytes. To report a case of a same-sex female couple who concomitantly cultured sibling oocytes intravaginally but had markedly different outcomes. Partner A underwent controlled ovarian stimulation (COS). Partner B underwent medicated uterine preparation for an anticipated fresh embryo transfer of embryos derived from Partner A’s IVC. Prior to egg retrieval, the couple was counseled that the expected egg yield would be significantly greater than the amount of oocytes that is recommended by the manufacturer to be used in a single INVOcell™ device. Options for the disposition of supernumerary eggs were discussed including the use of a second IVC device in Partner B and standard benchtop laboratory culture. Partner A’s egg retrieval yielded a total of 33 oocytes and the couple elected to use both additional culture options. 13 oocytes were fertilized and cultured in a benchtop incubator (Geri, Genea Biomedx, Sydney, Australia). Two INVOcell™ devices were loaded with 10 eggs each, placed intravaginally into each partner and removed after 5 days of culture. Standard benchtop culture of 13 oocytes yielded a total of 9 high-quality blastocysts. IVC of 10 oocytes in Partner A yielded a solitary degenerating blastocyst. IVC of 10 sibling oocytes in Partner B yielded three transfer-grade blastocysts. After extensive counseling, Partner B underwent an embryo transfer of two blastocysts, one from standard benchtop culture and one from Partner B’s IVC. An intrauterine pregnancy resulted and is currently ongoing. Same-sex female couples utilizing IVC should consider each carrying an INVOcell™ device. This approach allows more eggs to be cultured per cycle, requires a minimal amount of extra pre- and post-IVC lab work and potentially safeguards against a poor outcome in the event that one culture system fails to yield any usable embryos.

IS IN VIVO BETTER THAN IN VITRO? A COMPARISON OF SIBLING EMBRYO DEVELOPMENT AND PREGNANCY RATES THROUGH INVOCELL AND CONVENTIONAL IVF

To determine whether in vivo embryo development by INVOCELL intravaginal culture system is superior to in vitro by conventional IVF (cIVF) and whether pregnancy outcome is different by using sibling oocytes.

Профилактика осложненных родов путем нормализации вагинального микробиоценоза

Aim: to assess the effect of Lactobacilli on vaginal microbiocenosis in pregnant women with its pre-existing disturbances manifested as an increase in vaginal pH levels (>4.5) and pathological vaginal discharge in the 1st trimester of pregnancy. Patients and Methods: a prospective study involved 261 pregnant women who registered their pregnancy before 14 weeks. Group 1 included 147 women with vaginal pH>4.5 and gray white smelling discharge, but no cornified squamous epithelial cells and negative whiff test. Group 2 included 114 pregnant women with vaginal pH 3.8–4.5 and no vaginal discharge. At 11–14 weeks, 18–21 weeks, 30–34 weeks, and before delivery (36–41 weeks), vaginal pH, the composition of opportunistic flora, and Lactobacilli count were evaluated. In group 1, intravaginal lyophilized culture of L. casei rhamnosus (LCR) Doderleini was prescribed after each screening and before the delivery (in total, 4 courses). Results: the use of LCR preparation throughout the gestation reduced vaginal pH from 4.9 (11–14 weeks) to 4.5 (36–41 weeks) (p=0.001). In group 2, vaginal pH increased from 4.35 to 4.7 (p=0.000). In group 1 (probiotic containing LCR Lactobacilli was prescribed), the percentage of women with isolated L. jensenii strain increased by 1.6 times (from 9.52% to 14.96%). Meanwhile, in group 2 (no probiotic was prescribed), the percentage of women with isolated L. jensenii strain reduced by 4.2 times (from 14.91% to 3,51%; p=0.000). In group 1, abnormal birth activity and premature rupture of membranes were reported significantly less common (р=0.0001 and р=0.0001, respectively). Conclusions: probiotic containing LCR is favorable in terms of reducing the rate of pregnancy and birth complications. This fact is of particular importance for women who are at risk of bacterial vaginosis. KEYWORDS: pregnancy, Lactobacilli, vaginal microbiocenosis, pH measurement, probiotics. FOR CITATION: Karakhalis L.Yu., Ivantsiv N.S. Prevention of labor complication via the improvement of vaginal microbiocenosis. Russian Journal of Woman and Child Health. 2021;4(1):31–35. DOI: 10.32364/2618-8430-2021-4-1-31-35.

Real-world experience with intravaginal culture using INVOCELL: an alternative model for infertility treatment

ObjectiveTo describe the current practice indications, methodology, and outcomes from a real-world experience of intravaginal culture (IVC) using INVOCELL.DesignA descriptive study outlining real-world experience with INVOCELL that addresses patient selection, ovarian stimulation, embryology laboratory practices, and outcomes.SettingFive fertility centers in Missouri, Texas, North Carolina, South Carolina, and Virginia.PatientsFour hundred sixty-three patients undergoing 526 cycles.InterventionIVC using INVOCELL.Main Outcome MeasuresCumulative pregnancy rate and live births. Secondary outcomes of interest included percent good quality embryos.ResultsIVC with INVOCELL was primarily used in women <38 years with anti-Mullerian hormone level >0.8 ng/mL. The mean numbers of retrieved oocytes ranged from 9.2 to 16. Mean numbers of oocytes and sperm-injected oocytes loaded per INVOCELL ranged from a mean of 6.4–9.5 with a reported maximum of 34 oocytes loaded into the device. Most (95%) of the embryos were transferred on day 5. The mean blastocyst recovery per oocyte loaded into the device ranged from 19% to 34%; mean cumulative live birth plus ongoing pregnancy rates ranged from 29% to 53% per cycle start and 40% to 61% per transfer.ConclusionsThis study of IVC using INVOCELL as an alternative model for infertility treatment confirms its utility as a viable alternative to standard incubator-based in vitro fertilization. The technology is compatible within the current framework of practice patterns and, when appropriately used, results in acceptable blastocyst recovery and live birth rates. Further use of INVOCELL in other clinical situations is warranted.

Assessment of the INVOcell Intravaginal Culture System

Assessment of the INVOcell Intravaginal Culture System

Comparing bhcg values and pregnancy outcomes in intravaginal culture (IVC) to traditional in vitro incubation

Comparing bhcg values and pregnancy outcomes in intravaginal culture (IVC) to traditional in vitro incubation

A study to compare the birth outcomes of infants conceived by intravaginal culture using the invocellTM device and conventional in vitro fertilization in traditional incubators

A study to compare the birth outcomes of infants conceived by intravaginal culture using the invocellTM device and conventional in vitro fertilization in traditional incubators

Intravaginal embryo culture: more than just a novelty?

Intravaginal culture (IVC) devices offer a novel assisted reproductive technology (ART) treatment option at a significantly reduced cost from traditional in-vitro fertilization (IVF) cycles. This study aimed to assess the efficacy of the INVOcell (INVO Bioscience) intravaginal culture device with day 5 blastocyst transfers in our center compared with intrauterine insemination (IUI) cycles. Retrospective study. Patients were initially informed that IVC had unknown success rates in our clinic prior to starting their cycle. These cycles were offered at a discounted cost. Patient were only offered IVC as a potential treatment option if they met the following criteria: normal semen analysis, normal uterine cavity, anti-mullerian hormone value of 1 - 6 ng/mL, follicular stimulating hormone value of <10 mIU/mL, estradiol level <60 pg/mL, no previous IVF cycle failures, and no plastic allergies or history of toxic shock. Following oocyte retrieval, cumulus oocyte complexes were trimmed and inseminated for 5 minutes before being placed in an IVC device loaded with pre-equilibrated continuous culture media overlaid with mineral oil. The device was inserted into the patient’s vagina for incubation and carried for 5 days before she returned to have embryo development evaluated and an embryo transfer. IUI’s were performed with gradient prepared semen per standard protocols. Data was collected for a single calendar year in 2017. A total of 36 patients, between ages 27 and 42, opted to have IVC cycles performed. All patients were able to tolerate the device well, with no adverse events requiring premature removal of the device. The per-start positive biochemical pregnancy rate was 52% and the ultrasound confirmed pregnancy rate was 47%. The per-transfer pregnancy rates were 69% and 63% respectively with a total of 28 transfers performed (a 22% non-transfer rate). The pregnancy rates for IUI performed in the same calendar year were 13% and 12% respectively for patients in the same age bracket with a total of 869 cycles performed. IVC with day 5 blastocyst transfers appears to offer an appreciable pregnancy rate increase when compared with IUI cycles. While IVC cannot compete with full IVF cycles, due to inherent treatment limitations, it may offer a more efficacious first treatment option for infertility patients that meet the selection criteria than several rounds of IUIs. However, despite success for a large percentage of patients, we observed a high non-transfer rate of 22% due to either no fertilization or poor embryo progression. Although disappointing, these patients can now progress to full IVF cycles sooner than if they had continued with IUI cycles as IVC cycles offer more diagnostic value than IUIs. More research is needed to understand if IVC can effectively, in terms of cost and patient success, be added to most center’s treatment repertoires and become an additional standard of care.

Is intravaginal culture a more economical treatment for lesbian couples?

Is intravaginal culture a more economical treatment for lesbian couples?

Comparing blastocyst quality and live birth rates of intravaginal culture using INVOcell™ to traditional in vitro incubation in a randomized open-label prospective controlled trial.

PurposeThe purpose of this study is to to compare the efficacy of intravaginal culture (IVC) of embryos in INVOcell™ (INVO Bioscience, MA, USA) to traditional in vitro fertilization (IVF) incubators in a laboratory setting using a mild pre-determined stimulation regimen based solely on anti-mullerian hormone (AMH) and body weight with minimal ultrasound monitoring. The primary endpoint examined was total quality blastocysts expressed as a percentage of total oocytes placed in incubation. Secondary endpoints included percentage of quality blastocysts transferred, pregnancy, and live birth rates.MethodsIn this prospective randomized open-label controlled single-center study, 40 women aged <38 years of age with a body mass index (BMI) of <36 and an AMH of 1–3 ng/mL were randomized prior to trigger to receive either IVC or IVF. Controlled ovarian stimulation was administered with human menopausal gonadotropin (hMG) in a fixed gonadotropin-releasing hormone (GnRH) agonist cycle based solely on AMH and body weight. A single ultrasound-monitoring visit was performed on the 10th day of stimulation. One or two embryos were transferred following 5 days of culture.ResultsIVF produced a greater percentage of total quality embryos as compared to IVC (50.6 vs. 30.7 %, p = 0.0007, respectively). There was no significant difference between in IVF and IVC in the percentage of quality blastocysts transferred (97.5 vs. 84.9 %, p = 0.09) or live birth rate (60 % IVF, 55 % IVC).ConclusionsIVF was shown to be superior to IVC in creating quality blastocysts. However, both IVF and IVC produced identical blastocysts for transfer resulting in similar live birth rates. IVC using INVOcell™ is effective and may broaden access to fertility care in selected patient populations by ameliorating the need for a traditional IVF laboratory setting. Further studies will help elucidate the potential physiological, psychological, geographic, and financial impact of IVC on the delivery of fertility care.

A pilot study to evaluate a device for the intravaginal culture of embryos

The aim of this comparative randomized embryology trial was to determine if an intravaginal culture device (IVC) can provide acceptable embryo development compared with conventional IVF. Ten women between the ages of 27 and 37 years with an indication for IVF treatment were included in this study. After ovarian stimulation, oocytes were randomized to fertilization in the IVC device or using conventional IVF. Fertilization rates were higher in the IVF group compared with the IVC device (68.7% ± 36 % versus 40.7% ± 27%), respectively, whereas cleavage rates were similar (93% ± 1.5% versus 97% ± 6%) for both groups. A significantly lower number of embryos of suitable quality for transfer was obtained from the IVC device compared with conventional IVF (OR, 0.47; 95% CI, 0.26 to 0.87). The clinical pregnancy rate from transfer of IVC device embryos was 30%. Satisfaction questionnaires were also completed by all participants. Most women (70%) placed high importance on having had fertilization and embryo development occur while carrying the device. Overall, the IVC device produced reasonable pregnancy rates suggesting this technology may have a place under certain circumstances. Cost-benefit analysis, psychological factors and future studies must be considered.

In Vivo Culture System Using the INVOcell Device Shows Similar Pregnancy and Implantation Rates to Those Obtained from In Vivo Culture System in ICSI Procedures.

CAPSULEClinical outcomes using INVOcell device with ICSI.OBJECTIVEIntravaginal culture of oocytes (INVO) procedure is an intravaginal culture system that utilizes the INVOcell device in which the fertilization and embryo culture occur. In this procedure, the vaginal cavity serves as an incubator for oocyte fertilization and early embryonic development. The objective of this study was to evaluate the clinical outcomes of this intravaginal culture system in intracytoplasmic sperm injection (ICSI).METHODSA total of 24 cycles INVO-ICSI (study group) and 74 cycles of ICSI (control group) were included in the study. The cleaved oocytes at day 3/total injected oocytes, embryo quality, pregnancy rate (PR), implantation rate (IR), and miscarriage rate (MR) were compared between both groups.RESULTSAt day 3, there was no difference in the cleaved oocyte rate (78.7 and 76.1%) and embryo quality (77 and 86.8%) for the study and control groups, respectively. In the study group, more embryos were significantly transferred compared to the control group (2.63 ± 0.58 versus 1.93 ± 0.25; P < 0.05). PRs, IRs, and MRs were similar for the study group compared with the control group (PR: 54.2% versus 58.1%; IR: 31.7% versus 33.6%; MR: 7.7% versus 20.9%).CONCLUSIONSGood PR and IR can be obtained using the INVOcell device, and the INVO-ICSI procedure can be considered as an alternative option to infertile patients.

Invo & ICSI: a pioneer idea and a real alternative for ART

Intravaginal culture of oocytes (INVO) is an assisted reproductive technique (ART) that allows oocyte fertilization and early embryo development inside of air free, gas-permeable (CO2 and O2) plastic device called INVOcellTM. This study reports an application of INVO procedure for patients displaying male factor. After intracitoplasmatic sperm injection (ICSI) procedure, microinjected oocytes are placed into INVO device to be incubated inside of vaginal cavity. A total of 172 of cycles of couples showing male factor as cause of infertility were included in the INVO – ICSI protocol, from January to December 2012 in CECOLFES as a novel optional treatment in ART, showing similar results compared to classical ICSI procedures.

A randomized prospective controlled trial confirms the safety and efficacy of extended intravaginal culture of embryos with invocell compared to laboratory incubators

The purpose of this IRB approved trial is to compare the safety and efficacy of intravaginal culture of embryos in INVOcell (INVO Bioscience, MA, USA) to traditional incubator laboratory systems for the purpose of IVF.

Introduction of the method of intravaginal culture (IVC), through the device InVOCell routine laboratory RHA in Brazil

The conventional in vitro fertilization and the intracytoplasmic sperm microinjection are currently the established techniques for the treatment of infertility. In the last decade, however, the process of in vitro fertilization has suffered several changes in ovulation induction and oocyte retrieval (Ranoux 1990, ; ).The INVO procedure has been used to treat patients with different causes of infertility in many countries. This is a procedure which was developed over 20 years ago and is simpler and less costly to the infertility treatment when compared to conventional techniques. Interesting finding of this intravaginal culture technique are the physiological benefits and the reduction of the number of handling steps, reducing the risk of contamination. This study aimed to evaluate the possibility of including the method INVO through the use of the deviceINVOCell™ in routine laboratory treatments of couple infertility. That, in turn, tends to provide the simplification of laboratory work and thereby reduce the costs of infertility treatment. 40 women were included in this study, who were treated at the Service of Human Reproduction School Hospital Álvaro Alvim, in the period from August 2011 to January 2012. On all of them it was used the protocol of modified mild ovarian stimulation. The number of pre-embryos transferred into the uterine cavity followed the CFM Resolution nº. 1.957/10. There was no significant difference in the results presented by the device INVOCell™. Therefore showing that it can be included in routine laboratory assisted human reproduction.

INVO Procedure: Minimally Invasive IVF as an Alternative Treatment Option for Infertile Couples

Intravaginal culture (IVC), also called INVO (intravaginal culture of oocytes), is an assisted reproduction procedure where oocyte fertilization and early embryo development are carried out within a gas permeable air-free plastic device, placed into the maternal vaginal cavity for incubation. In the present study we assessed the outcome of the INVO procedure, using the recently designed INVOcell device, in combination with a mild ovarian stimulation protocol. A total of 125 cycles were performed. On average 6.5 oocytes per cycle were retrieved, and a mean of 4.2 were placed per INVOcell device. The cleavage rate obtained after the INVO culture was 63%. The procedure yielded 40%, 31.2%, and 24% of clinical pregnancy, live birth, and single live birth rates per cycle, respectively. Our results suggest that the INVO procedure is an effective alternative treatment option in assisted reproduction that shows comparable results to those reported for existing IVF techniques.