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

Mitri, Frederic; Esfandiari, Navid; Coogan-Prewer, Joan; Chang, Paul; Bentov, Yaakov; McNaught, John; Klement, Anat Hershko; Casper, Robert F.

doi:10.1016/j.rbmo.2015.09.005

Cited by 9 publications

(3 citation statements)

References 16 publications

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“…(2015) used ICSI embryos and found comparable Day 3 development and PRs. A pilot RCT of 10 patients showed that fertilization and PRs were higher with conventional IVF treatment as compared to fertilization in the device (CPR: 43% (per patient ET procedure) versus 30% (per cycle)) ( Mitri etal. , 2015 ).…”

Section: Resultsmentioning

confidence: 99%

Good practice recommendations on add-ons in reproductive medicine

Lundin,

Bentzen,

Bozdag

et al. 2023

Human Reproduction

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STUDY QUESTION Which add-ons are safe and effective to be used in ART treatment? SUMMARY ANSWER Forty-two recommendations were formulated on the use of add-ons in the diagnosis of fertility problems, the IVF laboratory and clinical management of IVF treatment. WHAT IS KNOWN ALREADY The innovative nature of ART combined with the extremely high motivation of the patients has opened the door to the wide application of what has become known as ‘add-ons’ in reproductive medicine. These supplementary options are available to patients in addition to standard fertility procedures, typically incurring an additional cost. A diverse array of supplementary options is made available, encompassing tests, drugs, equipment, complementary or alternative therapies, laboratory procedures, and surgical interventions. These options share the common aim of stating to enhance pregnancy or live birth rates, mitigate the risk of miscarriage, or expedite the time to achieving pregnancy. STUDY DESIGN, SIZE, DURATION ESHRE aimed to develop clinically relevant and evidence-based recommendations focusing on the safety and efficacy of add-ons currently used in fertility procedures in order to improve the quality of care for patients with infertility. PARTICIPANTS/MATERIALS, SETTING, METHODS ESHRE appointed a European multidisciplinary working group consisting of practising clinicians, embryologists, and researchers who have demonstrated leadership and expertise in the care and research of infertility. Patient representatives were included in the working group. To ensure that the guidelines are evidence-based, the literature identified from a systematic search was reviewed and critically appraised. In the absence of any clear scientific evidence, recommendations were based on the professional experience and consensus of the working group. The guidelines are thus based on the best available evidence and expert agreement. Prior to publication, the guidelines were reviewed by 46 independent international reviewers. A total of 272 comments were received and incorporated where relevant. MAIN RESULTS AND THE ROLE OF CHANCE The multidisciplinary working group formulated 42 recommendations in three sections; diagnosis and diagnostic tests, laboratory tests and interventions, and clinical management. LIMITATIONS, REASONS FOR CAUTION Of the 42 recommendations, none could be based on high-quality evidence and only four could be based on moderate-quality evidence, implicating that 95% of the recommendations are supported only by low-quality randomized controlled trials, observational data, professional experience, or consensus of the development group. WIDER IMPLICATIONS OF THE FINDINGS These guidelines offer valuable direction for healthcare professionals who are responsible for the care of patients undergoing ART treatment for infertility. Their purpose is to promote safe and effective ART treatment, enabling patients to make informed decisions based on realistic expectations. The guidelines aim to ensure that patients are fully informed about the various treatment options available to them and the likelihood of any additional treatment or test to improve the chance of achieving a live birth. STUDY FUNDING/COMPETING INTEREST(S) All costs relating to the development process were covered from ESHRE funds. There was no external funding of the development process or manuscript production. K.L. reports speakers fees from Merck and was part of a research study by Vitrolife (unpaid). T.E. reports consulting fees from Gynemed, speakers fees from Gynemed and is part of the scientific advisory board of Hamilton Thorne. N.P.P. reports grants from Merck Serono, Ferring Pharmaceutical, Theramex, Gedeon Richter, Organon, Roche, IBSA and Besins Healthcare, speakers fees from Merck Serono, Ferring Pharmaceutical, Theramex, Gedeon Richter, Organon, Roche, IBSA and Besins Healthcare. S.R.H. declares being managing director of Fertility Europe, a not-for-profit organization receiving financial support from ESHRE. I.S. is a scientific advisor for and has stock options from Alife Health, is co-founder of IVFvision LTD (unpaid) and received speakers’ fee from the 2023 ART Young Leader Prestige workshop in China. A.P. reports grants from Gedeon Richter, Ferring Pharmaceuticals and Merck A/S, consulting fees from Preglem, Novo Nordisk, Ferring Pharmaceuticals, Gedeon Richter, Cryos and Merck A/S, speakers fees from Gedeon Richter, Ferring Pharmaceuticals, Merck A/S, Theramex and Organon, travel fees from Gedeon Richter. The other authors disclosed no conflicts of interest. DISCLAIMER This Good Practice Recommendations (GPRs) document represents the views of ESHRE, which are the result of consensus between the relevant ESHRE stakeholders and are based on the scientific evidence available at the time of preparation. ESHRE GPRs should be used for information and educational purposes. They should not be interpreted as setting a standard of care or bedeemedinclusive of all proper methods of care, or be exclusive of other methods of care reasonably directed to obtaining the same results.Theydo not replace the need for application of clinical judgement to each individual presentation, or variations based on locality and facility type. Furthermore, ESHRE GPRs do not constitute or imply the endorsement, or favouring, of any of the included technologies by ESHRE.

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Section: Resultsmentioning

confidence: 99%

Good practice recommendations on add-ons in reproductive medicine

Lundin,

Bentzen,

Bozdag

et al. 2023

Human Reproduction

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“…By lowering costs, we were able to make assisted reproduction more democratic, reaching more couples with reproductive challenges. Studies carried out in several countries have shown good results using the technique in a three day culture ( Coelho et al, 2013 ; García-Ferreyra et al , 2015 ; Lucena et al , 2012 ; Mitri et al ., 2015 ). The use of the IVC technique in prolonged culture until the 5 th day of the embryo was reported by Doody et al (2016) with promising results.…”

Section: Discussionmentioning

confidence: 99%

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

Esmaeilzadeh¹,

Ghorbani²,

Abdolahzadeh³

et al. 2022

JBRA

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Objective 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. Methods 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. Results 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. Conclusions 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.

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“…The application of mild stimulation protocols in a low-resource population and in a primarily fellow operated setting has been shown to result in clinically significant pregnancy rates at significantly reduced costs ( 3 ). Additionally, intravaginal culture is a Food and Drug Administration–approved alternative to the use of traditional embryology laboratory incubators, which could, in some settings, lower costs; however, outcome data for this method are more limited ( 72 , 73 , 74 ). These and other strategies can be implemented by clinical programs operated by residents and/or fellows to help lower financial barriers for patients.…”

Section: Strategies To Improve Barriers In Access To Care Among Train...mentioning

confidence: 99%

See one, do one, teach one: Reimagining reproductive endocrinology and infertility training programs to expand access to care

Christ

Mehr

et al. 2022

F&S Reports

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Objective: To provide a review of the current literature surrounding barriers to reproductive medicine and present examples of how resident and fellow education can be used to overcome these barriers. Design: A review of the relevant literature addressing barriers to reproductive medicine, resident and fellow education, and related materials was completed. Setting: Academic medical institutions. Patient(s): None. Intervention(s): None. Main Outcome Measure(s): Health disparities and barriers in access to care. Result(s): Of barriers in access to care, 3 were reviewed in detail: cost of health care, racial inequities, and marginalization of immigrant communities. The suggested strategies to mitigate these barriers include the following: reducing racial inequities through improved diversity within reproductive medicine and through antiracism training, developing opportunities for trainees to engage in advocacy, strengthening reproductive endocrinology and infertility clinical exposure and educational curricula in training programs, inclusion of residents and fellows in clinical care, and improving the accessibility of fertility care through implementing approaches to optimize the management of infertility in challenging, resource-constrained settings. Conclusion(s):Infertility is one of the most prevalent reproductive health diseases, yet profound disparities and inequities in access to care exist today in the United States. Lower-income, minority, and immigrant communities are among those most marginalized. Improved access to care begins with broadened obstetrics and gynecology and reproductive endocrinology and infertility trainee education, which acknowledges the barriers these communities face and provides strategies to help overcome these obstacles to care.

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

Cited by 9 publications

References 16 publications

Good practice recommendations on add-ons in reproductive medicine

Good practice recommendations on add-ons in reproductive medicine

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

See one, do one, teach one: Reimagining reproductive endocrinology and infertility training programs to expand access to care

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